Hikma Pharmaceuticals
FDA Approved Drugs

Hikma Pharmaceuticals

FDA Approved Drugs Database

FDA approved drug product records including application numbers, product numbers, drug names, active ingredients, dosage forms, strengths, approval dates and regulatory status.

RX Discontinued Unclassified OTC
  • Total Records 1144
  • Latest Approval Date Jul 28, 2026
  • Data Source FDA
  • First Approval Date Jan 01, 1982
All
1144
View
Unclassified
29
View
Discontinued
529
View
OTC
1
View
RX
585
View
Company Overview

Company

Hikma Pharmaceuticals

Country

United Kingdom

Social Profiles

LinkedIn X / Twitter
Company Snapshot

Hikma Pharmaceuticals

1 New Burlington Place, Mayfair, London, W1S 2HR

United Kingdom

www.hikma.com/home/ Sarrar@hikma.com View on Map
FDA Approved Drug Records ( 1144 records )
2018
31 Oct
RX Application: 208339

Drug Name

ABIRATERONE ACETATE

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2018-10-31

208339 / 1

Active Ingredient

ABIRATERONE ACETATE

Application Number

208339

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2018-10-31

Regulatory Status

RX

2008
07 May
RX Application: 78470

Drug Name

ACARBOSE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2008-05-07

78470 / 1

Active Ingredient

ACARBOSE

Application Number

78470

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2008-05-07

Regulatory Status

RX

2008
07 May
RX Application: 78470

Drug Name

ACARBOSE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2008-05-07

78470 / 2

Active Ingredient

ACARBOSE

Application Number

78470

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2008-05-07

Regulatory Status

RX

2008
07 May
RX Application: 78470

Drug Name

ACARBOSE

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2008-05-07

78470 / 3

Active Ingredient

ACARBOSE

Application Number

78470

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2008-05-07

Regulatory Status

RX

2016
13 Jun
RX Application: 202605

Drug Name

ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

1GM/100ML (10MG/ML)

Approval Date

2016-06-13

202605 / 1

Active Ingredient

ACETAMINOPHEN

Application Number

202605

Product Number

1

Dosage Form

-

Strength

1GM/100ML (10MG/ML)

Approval Date

2016-06-13

Regulatory Status

RX

2022
03 Jun
RX Application: 206968

Drug Name

ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

1GM/100ML (10MG/ML)

Approval Date

2022-06-03

206968 / 1

Active Ingredient

ACETAMINOPHEN

Application Number

206968

Product Number

1

Dosage Form

-

Strength

1GM/100ML (10MG/ML)

Approval Date

2022-06-03

Regulatory Status

RX

1995
28 Feb
RX Application: 40089

Drug Name

ACETAZOLAMIDE SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1995-02-28

40089 / 1

Active Ingredient

ACETAZOLAMIDE SODIUM

Application Number

40089

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1995-02-28

Regulatory Status

RX

2005
07 Jun
Discontinued Application: 77026

Drug Name

ACYCLOVIR

Product Number

1

Dosage Form

-

Strength

200MG/5ML

Approval Date

2005-06-07

77026 / 1

Active Ingredient

ACYCLOVIR

Application Number

77026

Product Number

1

Dosage Form

-

Strength

200MG/5ML

Approval Date

2005-06-07

Regulatory Status

Discontinued

1997
19 Dec
Discontinued Application: 74885

Drug Name

ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1997-12-19

74885 / 1

Active Ingredient

ACYCLOVIR SODIUM

Application Number

74885

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1997-12-19

Regulatory Status

Discontinued

1997
19 Dec
Discontinued Application: 74885

Drug Name

ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1997-12-19

74885 / 2

Active Ingredient

ACYCLOVIR SODIUM

Application Number

74885

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1997-12-19

Regulatory Status

Discontinued

1997
15 Oct
Discontinued Application: 74913

Drug Name

ACYCLOVIR SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1997-10-15

74913 / 1

Active Ingredient

ACYCLOVIR SODIUM

Application Number

74913

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1997-10-15

Regulatory Status

Discontinued

1997
15 Oct
Discontinued Application: 74913

Drug Name

ACYCLOVIR SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1997-10-15

74913 / 2

Active Ingredient

ACYCLOVIR SODIUM

Application Number

74913

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1997-10-15

Regulatory Status

Discontinued

2016
29 Feb
Discontinued Application: 205771

Drug Name

ACYCLOVIR SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2016-02-29

205771 / 1

Active Ingredient

ACYCLOVIR SODIUM

Application Number

205771

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2016-02-29

Regulatory Status

Discontinued

2016
29 Feb
Discontinued Application: 205771

Drug Name

ACYCLOVIR SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2016-02-29

205771 / 2

Active Ingredient

ACYCLOVIR SODIUM

Application Number

205771

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2016-02-29

Regulatory Status

Discontinued

2004
16 Jun
RX Application: 76404

Drug Name

ADENOSINE

Product Number

1

Dosage Form

-

Strength

3MG/ML

Approval Date

2004-06-16

76404 / 1

Active Ingredient

ADENOSINE

Application Number

76404

Product Number

1

Dosage Form

-

Strength

3MG/ML

Approval Date

2004-06-16

Regulatory Status

RX

2004
16 Jun
RX Application: 76500

Drug Name

ADENOSINE

Product Number

1

Dosage Form

-

Strength

3MG/ML

Approval Date

2004-06-16

76500 / 1

Active Ingredient

ADENOSINE

Application Number

76500

Product Number

1

Dosage Form

-

Strength

3MG/ML

Approval Date

2004-06-16

Regulatory Status

RX

2004
16 Jun
Discontinued Application: 76501

Drug Name

ADENOSINE

Product Number

1

Dosage Form

-

Strength

3MG/ML

Approval Date

2004-06-16

76501 / 1

Active Ingredient

ADENOSINE

Application Number

76501

Product Number

1

Dosage Form

-

Strength

3MG/ML

Approval Date

2004-06-16

Regulatory Status

Discontinued

1998
30 Jan
Discontinued Application: 74749

Drug Name

ALBUTEROL SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/5ML

Approval Date

1998-01-30

74749 / 1

Active Ingredient

ALBUTEROL SULFATE

Application Number

74749

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/5ML

Approval Date

1998-01-30

Regulatory Status

Discontinued

2013
25 Feb
RX Application: 90520

Drug Name

ALENDRONATE SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 70MG BASE/75ML

Approval Date

2013-02-25

90520 / 1

Active Ingredient

ALENDRONATE SODIUM

Application Number

90520

Product Number

1

Dosage Form

-

Strength

EQ 70MG BASE/75ML

Approval Date

2013-02-25

Regulatory Status

RX

2004
26 Aug
RX Application: 76870

Drug Name

ALLOPURINOL SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2004-08-26

76870 / 1

Active Ingredient

ALLOPURINOL SODIUM

Application Number

76870

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2004-08-26

Regulatory Status

RX

2015
04 May
Discontinued Application: 200652

Drug Name

ALOSETRON HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE

Approval Date

2015-05-04

200652 / 1

Active Ingredient

ALOSETRON HYDROCHLORIDE

Application Number

200652

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE

Approval Date

2015-05-04

Regulatory Status

Discontinued

2015
04 May
Discontinued Application: 200652

Drug Name

ALOSETRON HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2015-05-04

200652 / 2

Active Ingredient

ALOSETRON HYDROCHLORIDE

Application Number

200652

Product Number

2

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2015-05-04

Regulatory Status

Discontinued

1993
31 Oct
RX Application: 74312

Drug Name

ALPRAZOLAM

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

1993-10-31

74312 / 1

Active Ingredient

ALPRAZOLAM

Application Number

74312

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

1993-10-31

Regulatory Status

RX

1998
20 Jan
RX Application: 74815

Drug Name

ALPROSTADIL

Product Number

1

Dosage Form

-

Strength

0.5MG/ML

Approval Date

1998-01-20

74815 / 1

Active Ingredient

ALPROSTADIL

Application Number

74815

Product Number

1

Dosage Form

-

Strength

0.5MG/ML

Approval Date

1998-01-20

Regulatory Status

RX

2023
31 Aug
RX Application: 217753

Drug Name

ALVIMOPAN

Product Number

1

Dosage Form

-

Strength

12MG

Approval Date

2023-08-31

217753 / 1

Active Ingredient

ALVIMOPAN

Application Number

217753

Product Number

1

Dosage Form

-

Strength

12MG

Approval Date

2023-08-31

Regulatory Status

RX

1982
01 Jan
RX Application: 15197

Drug Name

AMICAR

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

15197 / 1

Active Ingredient

AMINOCAPROIC ACID

Application Number

15197

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

Regulatory Status

RX

2004
24 Jun
RX Application: 15197

Drug Name

AMICAR

Product Number

2

Dosage Form

-

Strength

1GM

Approval Date

2004-06-24

15197 / 2

Active Ingredient

AMINOCAPROIC ACID

Application Number

15197

Product Number

2

Dosage Form

-

Strength

1GM

Approval Date

2004-06-24

Regulatory Status

RX

1982
01 Jan
RX Application: 15230

Drug Name

AMICAR

Product Number

2

Dosage Form

-

Strength

0.25GM/ML

Approval Date

1982-01-01

15230 / 2

Active Ingredient

AMINOCAPROIC ACID

Application Number

15230

Product Number

2

Dosage Form

-

Strength

0.25GM/ML

Approval Date

1982-01-01

Regulatory Status

RX

1992
18 May
Discontinued Application: 63274

Drug Name

AMIKACIN SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/ML

Approval Date

1992-05-18

63274 / 1

Active Ingredient

AMIKACIN SULFATE

Application Number

63274

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/ML

Approval Date

1992-05-18

Regulatory Status

Discontinued

1992
18 May
Discontinued Application: 63275

Drug Name

AMIKACIN SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE/ML

Approval Date

1992-05-18

63275 / 1

Active Ingredient

AMIKACIN SULFATE

Application Number

63275

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE/ML

Approval Date

1992-05-18

Regulatory Status

Discontinued

1994
11 Apr
RX Application: 63313

Drug Name

AMIKACIN SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/ML

Approval Date

1994-04-11

63313 / 1

Active Ingredient

AMIKACIN SULFATE

Application Number

63313

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/ML

Approval Date

1994-04-11

Regulatory Status

RX

1994
11 Apr
RX Application: 63315

Drug Name

AMIKACIN SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE/ML

Approval Date

1994-04-11

63315 / 1

Active Ingredient

AMIKACIN SULFATE

Application Number

63315

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE/ML

Approval Date

1994-04-11

Regulatory Status

RX

2001
24 May
Discontinued Application: 75602

Drug Name

AMINOCAPROIC

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2001-05-24

75602 / 1

Active Ingredient

AMINOCAPROIC ACID

Application Number

75602

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2001-05-24

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84540

Drug Name

AMINOPHYLLINE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

84540 / 1

Active Ingredient

AMINOPHYLLINE

Application Number

84540

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85003

Drug Name

AMINOPHYLLINE

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1982-01-01

85003 / 1

Active Ingredient

AMINOPHYLLINE

Application Number

85003

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2008
25 Feb
RX Application: 77234

Drug Name

AMIODARONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

2008-02-25

77234 / 1

Active Ingredient

AMIODARONE HYDROCHLORIDE

Application Number

77234

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

2008-02-25

Regulatory Status

RX

2007
09 Jul
Discontinued Application: 77262

Drug Name

AMLODIPINE BESYLATE

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2007-07-09

77262 / 1

Active Ingredient

AMLODIPINE BESYLATE

Application Number

77262

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2007-07-09

Regulatory Status

Discontinued

2007
09 Jul
Discontinued Application: 77262

Drug Name

AMLODIPINE BESYLATE

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2007-07-09

77262 / 2

Active Ingredient

AMLODIPINE BESYLATE

Application Number

77262

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2007-07-09

Regulatory Status

Discontinued

2007
09 Jul
Discontinued Application: 77262

Drug Name

AMLODIPINE BESYLATE

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2007-07-09

77262 / 3

Active Ingredient

AMLODIPINE BESYLATE

Application Number

77262

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2007-07-09

Regulatory Status

Discontinued

2011
12 Apr
Discontinued Application: 77771

Drug Name

AMLODIPINE BESYLATE

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2011-04-12

77771 / 1

Active Ingredient

AMLODIPINE BESYLATE

Application Number

77771

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2011-04-12

Regulatory Status

Discontinued

2011
12 Apr
Discontinued Application: 77771

Drug Name

AMLODIPINE BESYLATE

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2011-04-12

77771 / 2

Active Ingredient

AMLODIPINE BESYLATE

Application Number

77771

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2011-04-12

Regulatory Status

Discontinued

2011
12 Apr
Discontinued Application: 77771

Drug Name

AMLODIPINE BESYLATE

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2011-04-12

77771 / 3

Active Ingredient

AMLODIPINE BESYLATE

Application Number

77771

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2011-04-12

Regulatory Status

Discontinued

2006
29 Mar
RX Application: 65255

Drug Name

AMOXICILLIN

Product Number

1

Dosage Form

-

Strength

875MG

Approval Date

2006-03-29

65255 / 1

Active Ingredient

AMOXICILLIN

Application Number

65255

Product Number

1

Dosage Form

-

Strength

875MG

Approval Date

2006-03-29

Regulatory Status

RX

2007
05 Feb
RX Application: 65291

Drug Name

AMOXICILLIN

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2007-02-05

65291 / 1

Active Ingredient

AMOXICILLIN

Application Number

65291

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2007-02-05

Regulatory Status

RX

2007
05 Feb
RX Application: 65291

Drug Name

AMOXICILLIN

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2007-02-05

65291 / 2

Active Ingredient

AMOXICILLIN

Application Number

65291

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2007-02-05

Regulatory Status

RX

2006
19 Jun
RX Application: 65322

Drug Name

AMOXICILLIN

Product Number

1

Dosage Form

-

Strength

250MG/5ML

Approval Date

2006-06-19

65322 / 1

Active Ingredient

AMOXICILLIN

Application Number

65322

Product Number

1

Dosage Form

-

Strength

250MG/5ML

Approval Date

2006-06-19

Regulatory Status

RX

2006
19 Jun
RX Application: 65322

Drug Name

AMOXICILLIN

Product Number

2

Dosage Form

-

Strength

125MG/5ML

Approval Date

2006-06-19

65322 / 2

Active Ingredient

AMOXICILLIN

Application Number

65322

Product Number

2

Dosage Form

-

Strength

125MG/5ML

Approval Date

2006-06-19

Regulatory Status

RX

2006
19 Jun
RX Application: 65325

Drug Name

AMOXICILLIN

Product Number

1

Dosage Form

-

Strength

400MG/5ML

Approval Date

2006-06-19

65325 / 1

Active Ingredient

AMOXICILLIN

Application Number

65325

Product Number

1

Dosage Form

-

Strength

400MG/5ML

Approval Date

2006-06-19

Regulatory Status

RX

2006
19 Jun
RX Application: 65325

Drug Name

AMOXICILLIN

Product Number

2

Dosage Form

-

Strength

200MG/5ML

Approval Date

2006-06-19

65325 / 2

Active Ingredient

AMOXICILLIN

Application Number

65325

Product Number

2

Dosage Form

-

Strength

200MG/5ML

Approval Date

2006-06-19

Regulatory Status

RX

2020
25 Jun
Discontinued Application: 205274

Drug Name

AMOXICILLIN

Product Number

1

Dosage Form

-

Strength

125MG

Approval Date

2020-06-25

205274 / 1

Active Ingredient

AMOXICILLIN

Application Number

205274

Product Number

1

Dosage Form

-

Strength

125MG

Approval Date

2020-06-25

Regulatory Status

Discontinued

2020
25 Jun
Discontinued Application: 205274

Drug Name

AMOXICILLIN

Product Number

2

Dosage Form

-

Strength

250MG

Approval Date

2020-06-25

205274 / 2

Active Ingredient

AMOXICILLIN

Application Number

205274

Product Number

2

Dosage Form

-

Strength

250MG

Approval Date

2020-06-25

Regulatory Status

Discontinued

2005
25 Jan
RX Application: 65191

Drug Name

AMOXICILLIN AND CLAVULANATE POTASSIUM

Product Number

1

Dosage Form

-

Strength

400MG/5ML;EQ 57MG BASE/5ML

Approval Date

2005-01-25

65191 / 1

Active Ingredient

AMOXICILLIN; CLAVULANATE POTASSIUM

Application Number

65191

Product Number

1

Dosage Form

-

Strength

400MG/5ML;EQ 57MG BASE/5ML

Approval Date

2005-01-25

Regulatory Status

RX

2005
25 Jan
RX Application: 65191

Drug Name

AMOXICILLIN AND CLAVULANATE POTASSIUM

Product Number

2

Dosage Form

-

Strength

200MG/5ML;EQ 28.5MG BASE/5ML

Approval Date

2005-01-25

65191 / 2

Active Ingredient

AMOXICILLIN; CLAVULANATE POTASSIUM

Application Number

65191

Product Number

2

Dosage Form

-

Strength

200MG/5ML;EQ 28.5MG BASE/5ML

Approval Date

2005-01-25

Regulatory Status

RX

2007
09 Nov
RX Application: 65373

Drug Name

AMOXICILLIN AND CLAVULANATE POTASSIUM

Product Number

1

Dosage Form

-

Strength

600MG/5ML;EQ 42.9MG BASE/5ML

Approval Date

2007-11-09

65373 / 1

Active Ingredient

AMOXICILLIN; CLAVULANATE POTASSIUM

Application Number

65373

Product Number

1

Dosage Form

-

Strength

600MG/5ML;EQ 42.9MG BASE/5ML

Approval Date

2007-11-09

Regulatory Status

RX

2016
23 Aug
RX Application: 203824

Drug Name

AMOXICILLIN AND CLAVULANATE POTASSIUM

Product Number

1

Dosage Form

-

Strength

875MG;EQ 125MG BASE

Approval Date

2016-08-23

203824 / 1

Active Ingredient

AMOXICILLIN; CLAVULANATE POTASSIUM

Application Number

203824

Product Number

1

Dosage Form

-

Strength

875MG;EQ 125MG BASE

Approval Date

2016-08-23

Regulatory Status

RX

2002
19 Mar
Discontinued Application: 65074

Drug Name

AMPICILLIN AND SULBACTAM

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL

Approval Date

2002-03-19

65074 / 1

Active Ingredient

AMPICILLIN SODIUM; SULBACTAM SODIUM

Application Number

65074

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL

Approval Date

2002-03-19

Regulatory Status

Discontinued

2002
19 Mar
Discontinued Application: 65074

Drug Name

AMPICILLIN AND SULBACTAM

Product Number

2

Dosage Form

-

Strength

EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL

Approval Date

2002-03-19

65074 / 2

Active Ingredient

AMPICILLIN SODIUM; SULBACTAM SODIUM

Application Number

65074

Product Number

2

Dosage Form

-

Strength

EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL

Approval Date

2002-03-19

Regulatory Status

Discontinued

2002
19 Mar
RX Application: 65076

Drug Name

AMPICILLIN AND SULBACTAM

Product Number

1

Dosage Form

-

Strength

EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL

Approval Date

2002-03-19

65076 / 1

Active Ingredient

AMPICILLIN SODIUM; SULBACTAM SODIUM

Application Number

65076

Product Number

1

Dosage Form

-

Strength

EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL

Approval Date

2002-03-19

Regulatory Status

RX

1986
24 Jun
Discontinued Application: 62692

Drug Name

AMPICILLIN SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE/VIAL

Approval Date

1986-06-24

62692 / 1

Active Ingredient

AMPICILLIN SODIUM

Application Number

62692

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE/VIAL

Approval Date

1986-06-24

Regulatory Status

Discontinued

1986
24 Jun
Discontinued Application: 62692

Drug Name

AMPICILLIN SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE/VIAL

Approval Date

1986-06-24

62692 / 2

Active Ingredient

AMPICILLIN SODIUM

Application Number

62692

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE/VIAL

Approval Date

1986-06-24

Regulatory Status

Discontinued

1986
24 Jun
Discontinued Application: 62692

Drug Name

AMPICILLIN SODIUM

Product Number

3

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1986-06-24

62692 / 3

Active Ingredient

AMPICILLIN SODIUM

Application Number

62692

Product Number

3

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1986-06-24

Regulatory Status

Discontinued

1986
24 Jun
Discontinued Application: 62692

Drug Name

AMPICILLIN SODIUM

Product Number

4

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1986-06-24

62692 / 4

Active Ingredient

AMPICILLIN SODIUM

Application Number

62692

Product Number

4

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1986-06-24

Regulatory Status

Discontinued

1986
24 Jun
Discontinued Application: 62692

Drug Name

AMPICILLIN SODIUM

Product Number

5

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

1986-06-24

62692 / 5

Active Ingredient

AMPICILLIN SODIUM

Application Number

62692

Product Number

5

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

1986-06-24

Regulatory Status

Discontinued

1986
24 Jun
Discontinued Application: 62692

Drug Name

AMPICILLIN SODIUM

Product Number

6

Dosage Form

-

Strength

EQ 10GM BASE/VIAL

Approval Date

1986-06-24

62692 / 6

Active Ingredient

AMPICILLIN SODIUM

Application Number

62692

Product Number

6

Dosage Form

-

Strength

EQ 10GM BASE/VIAL

Approval Date

1986-06-24

Regulatory Status

Discontinued

2000
09 May
RX Application: 75513

Drug Name

AMRINONE LACTATE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

2000-05-09

75513 / 1

Active Ingredient

INAMRINONE LACTATE

Application Number

75513

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

2000-05-09

Regulatory Status

RX

2010
28 Jun
Discontinued Application: 78485

Drug Name

ANASTROZOLE

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2010-06-28

78485 / 1

Active Ingredient

ANASTROZOLE

Application Number

78485

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2010-06-28

Regulatory Status

Discontinued

2012
05 Jan
RX Application: 203049

Drug Name

ARGATROBAN

Product Number

1

Dosage Form

-

Strength

250MG/2.5ML (100MG/ML)

Approval Date

2012-01-05

203049 / 1

Active Ingredient

ARGATROBAN

Application Number

203049

Product Number

1

Dosage Form

-

Strength

250MG/2.5ML (100MG/ML)

Approval Date

2012-01-05

Regulatory Status

RX

2016
30 Sep
RX Application: 203049

Drug Name

ARGATROBAN

Product Number

2

Dosage Form

-

Strength

50MG/50ML (1MG/ML)

Approval Date

2016-09-30

203049 / 2

Active Ingredient

ARGATROBAN

Application Number

203049

Product Number

2

Dosage Form

-

Strength

50MG/50ML (1MG/ML)

Approval Date

2016-09-30

Regulatory Status

RX

1982
01 Jan
RX Application: 18140

Drug Name

ATIVAN

Product Number

1

Dosage Form

-

Strength

2MG/ML

Approval Date

1982-01-01

18140 / 1

Active Ingredient

LORAZEPAM

Application Number

18140

Product Number

1

Dosage Form

-

Strength

2MG/ML

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 18140

Drug Name

ATIVAN

Product Number

2

Dosage Form

-

Strength

4MG/ML

Approval Date

1982-01-01

18140 / 2

Active Ingredient

LORAZEPAM

Application Number

18140

Product Number

2

Dosage Form

-

Strength

4MG/ML

Approval Date

1982-01-01

Regulatory Status

RX

1997
18 Jul
RX Application: 74901

Drug Name

ATRACURIUM BESYLATE

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1997-07-18

74901 / 1

Active Ingredient

ATRACURIUM BESYLATE

Application Number

74901

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1997-07-18

Regulatory Status

RX

1997
18 Jul
RX Application: 74900

Drug Name

ATRACURIUM BESYLATE PRESERVATIVE FREE

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1997-07-18

74900 / 1

Active Ingredient

ATRACURIUM BESYLATE

Application Number

74900

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1997-07-18

Regulatory Status

RX

2021
01 Dec
RX Application: 213561

Drug Name

ATROPINE SULFATE

Product Number

1

Dosage Form

-

Strength

8MG/20ML (0.4MG/ML)

Approval Date

2021-12-01

213561 / 1

Active Ingredient

ATROPINE SULFATE

Application Number

213561

Product Number

1

Dosage Form

-

Strength

8MG/20ML (0.4MG/ML)

Approval Date

2021-12-01

Regulatory Status

RX

2025
24 Oct
RX Application: 217345

Drug Name

ATROPINE SULFATE

Product Number

1

Dosage Form

-

Strength

0.4MG/ML (0.4MG/ML)

Approval Date

2025-10-24

217345 / 1

Active Ingredient

ATROPINE SULFATE

Application Number

217345

Product Number

1

Dosage Form

-

Strength

0.4MG/ML (0.4MG/ML)

Approval Date

2025-10-24

Regulatory Status

RX

2025
24 Oct
RX Application: 217345

Drug Name

ATROPINE SULFATE

Product Number

2

Dosage Form

-

Strength

1MG/ML (1MG/ML)

Approval Date

2025-10-24

217345 / 2

Active Ingredient

ATROPINE SULFATE

Application Number

217345

Product Number

2

Dosage Form

-

Strength

1MG/ML (1MG/ML)

Approval Date

2025-10-24

Regulatory Status

RX

2020
08 Jun
RX Application: 209337

Drug Name

AZACITIDINE

Product Number

1

Dosage Form

-

Strength

100MG/VIAL

Approval Date

2020-06-08

209337 / 1

Active Ingredient

AZACITIDINE

Application Number

209337

Product Number

1

Dosage Form

-

Strength

100MG/VIAL

Approval Date

2020-06-08

Regulatory Status

RX

1995
31 Mar
RX Application: 74419

Drug Name

AZATHIOPRINE SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE/VIAL

Approval Date

1995-03-31

74419 / 1

Active Ingredient

AZATHIOPRINE SODIUM

Application Number

74419

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE/VIAL

Approval Date

1995-03-31

Regulatory Status

RX

2014
24 Oct
Discontinued Application: 91444

Drug Name

AZELASTINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.137MG/SPRAY

Approval Date

2014-10-24

91444 / 1

Active Ingredient

AZELASTINE HYDROCHLORIDE

Application Number

91444

Product Number

1

Dosage Form

-

Strength

0.137MG/SPRAY

Approval Date

2014-10-24

Regulatory Status

Discontinued

2017
22 Sep
Discontinued Application: 207243

Drug Name

AZELASTINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.2055MG/SPRAY

Approval Date

2017-09-22

207243 / 1

Active Ingredient

AZELASTINE HYDROCHLORIDE

Application Number

207243

Product Number

1

Dosage Form

-

Strength

0.2055MG/SPRAY

Approval Date

2017-09-22

Regulatory Status

Discontinued

2007
18 Jan
Discontinued Application: 65265

Drug Name

AZITHROMYCIN

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2007-01-18

65265 / 1

Active Ingredient

AZITHROMYCIN

Application Number

65265

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2007-01-18

Regulatory Status

Discontinued

2011
23 Mar
Discontinued Application: 65286

Drug Name

AZTREONAM

Product Number

1

Dosage Form

-

Strength

1GM/VIAL

Approval Date

2011-03-23

65286 / 1

Active Ingredient

AZTREONAM

Application Number

65286

Product Number

1

Dosage Form

-

Strength

1GM/VIAL

Approval Date

2011-03-23

Regulatory Status

Discontinued

2011
23 Mar
Discontinued Application: 65286

Drug Name

AZTREONAM

Product Number

2

Dosage Form

-

Strength

2GM/VIAL

Approval Date

2011-03-23

65286 / 2

Active Ingredient

AZTREONAM

Application Number

65286

Product Number

2

Dosage Form

-

Strength

2GM/VIAL

Approval Date

2011-03-23

Regulatory Status

Discontinued

2026
05 Feb
Discontinued Application: 207069

Drug Name

AZTREONAM

Product Number

1

Dosage Form

-

Strength

1GM/VIAL

Approval Date

2026-02-05

207069 / 1

Active Ingredient

AZTREONAM

Application Number

207069

Product Number

1

Dosage Form

-

Strength

1GM/VIAL

Approval Date

2026-02-05

Regulatory Status

Discontinued

2026
05 Feb
Discontinued Application: 207069

Drug Name

AZTREONAM

Product Number

2

Dosage Form

-

Strength

2GM/VIAL

Approval Date

2026-02-05

207069 / 2

Active Ingredient

AZTREONAM

Application Number

207069

Product Number

2

Dosage Form

-

Strength

2GM/VIAL

Approval Date

2026-02-05

Regulatory Status

Discontinued

2007
28 Dec
RX Application: 77806

Drug Name

BALSALAZIDE DISODIUM

Product Number

1

Dosage Form

-

Strength

750MG

Approval Date

2007-12-28

77806 / 1

Active Ingredient

BALSALAZIDE DISODIUM

Application Number

77806

Product Number

1

Dosage Form

-

Strength

750MG

Approval Date

2007-12-28

Regulatory Status

RX

2009
31 Aug
RX Application: 90287

Drug Name

BENZTROPINE MESYLATE

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2009-08-31

90287 / 1

Active Ingredient

BENZTROPINE MESYLATE

Application Number

90287

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2009-08-31

Regulatory Status

RX

2021
14 Oct
RX Application: 209442

Drug Name

BENZTROPINE MESYLATE

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2021-10-14

209442 / 1

Active Ingredient

BENZTROPINE MESYLATE

Application Number

209442

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2021-10-14

Regulatory Status

RX

2023
17 Jan
RX Application: 77838

Drug Name

BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE

Product Number

1

Dosage Form

-

Strength

3MG/ML;EQ 3MG BASE/ML

Approval Date

2023-01-17

77838 / 1

Active Ingredient

BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE

Application Number

77838

Product Number

1

Dosage Form

-

Strength

3MG/ML;EQ 3MG BASE/ML

Approval Date

2023-01-17

Regulatory Status

RX

2019
11 Oct
Discontinued Application: 208849

Drug Name

BETAMETHASONE DIPROPIONATE

Product Number

1

Dosage Form

-

Strength

EQ 0.05% BASE

Approval Date

2019-10-11

208849 / 1

Active Ingredient

BETAMETHASONE DIPROPIONATE

Application Number

208849

Product Number

1

Dosage Form

-

Strength

EQ 0.05% BASE

Approval Date

2019-10-11

Regulatory Status

Discontinued

2018
06 Feb
Discontinued Application: 209896

Drug Name

BETAMETHASONE DIPROPIONATE

Product Number

1

Dosage Form

-

Strength

EQ 0.05% BASE

Approval Date

2018-02-06

209896 / 1

Active Ingredient

BETAMETHASONE DIPROPIONATE

Application Number

209896

Product Number

1

Dosage Form

-

Strength

EQ 0.05% BASE

Approval Date

2018-02-06

Regulatory Status

Discontinued

2020
16 Jun
RX Application: 203663

Drug Name

BEXAROTENE

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

2020-06-16

203663 / 1

Active Ingredient

BEXAROTENE

Application Number

203663

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

2020-06-16

Regulatory Status

RX

2018
09 Oct
Discontinued Application: 203051

Drug Name

BIMATOPROST

Product Number

1

Dosage Form

-

Strength

0.03%

Approval Date

2018-10-09

203051 / 1

Active Ingredient

BIMATOPROST

Application Number

203051

Product Number

1

Dosage Form

-

Strength

0.03%

Approval Date

2018-10-09

Regulatory Status

Discontinued

2018
08 Nov
Discontinued Application: 203299

Drug Name

BIMATOPROST

Product Number

1

Dosage Form

-

Strength

0.03%

Approval Date

2018-11-08

203299 / 1

Active Ingredient

BIMATOPROST

Application Number

203299

Product Number

1

Dosage Form

-

Strength

0.03%

Approval Date

2018-11-08

Regulatory Status

Discontinued

2001
17 Oct
RX Application: 65042

Drug Name

BLEOMYCIN SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 30 UNITS BASE/VIAL

Approval Date

2001-10-17

65042 / 1

Active Ingredient

BLEOMYCIN SULFATE

Application Number

65042

Product Number

1

Dosage Form

-

Strength

EQ 30 UNITS BASE/VIAL

Approval Date

2001-10-17

Regulatory Status

RX

2001
17 Oct
RX Application: 65042

Drug Name

BLEOMYCIN SULFATE

Product Number

2

Dosage Form

-

Strength

EQ 15 UNITS BASE/VIAL

Approval Date

2001-10-17

65042 / 2

Active Ingredient

BLEOMYCIN SULFATE

Application Number

65042

Product Number

2

Dosage Form

-

Strength

EQ 15 UNITS BASE/VIAL

Approval Date

2001-10-17

Regulatory Status

RX

2019
26 Apr
Discontinued Application: 208695

Drug Name

BOSENTAN

Product Number

1

Dosage Form

-

Strength

62.5MG

Approval Date

2019-04-26

208695 / 1

Active Ingredient

BOSENTAN

Application Number

208695

Product Number

1

Dosage Form

-

Strength

62.5MG

Approval Date

2019-04-26

Regulatory Status

Discontinued

2019
26 Apr
Discontinued Application: 208695

Drug Name

BOSENTAN

Product Number

2

Dosage Form

-

Strength

125MG

Approval Date

2019-04-26

208695 / 2

Active Ingredient

BOSENTAN

Application Number

208695

Product Number

2

Dosage Form

-

Strength

125MG

Approval Date

2019-04-26

Regulatory Status

Discontinued

1986
14 May
Discontinued Application: 70545

Drug Name

BRETYLIUM TOSYLATE

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

1986-05-14

70545 / 1

Active Ingredient

BRETYLIUM TOSYLATE

Application Number

70545

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

1986-05-14

Regulatory Status

Discontinued

1986
14 May
Discontinued Application: 70546

Drug Name

BRETYLIUM TOSYLATE

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

1986-05-14

70546 / 1

Active Ingredient

BRETYLIUM TOSYLATE

Application Number

70546

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

1986-05-14

Regulatory Status

Discontinued

2021
11 Feb
RX Application: 205141

Drug Name

BUPIVACAINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.25%

Approval Date

2021-02-11

205141 / 1

Active Ingredient

BUPIVACAINE HYDROCHLORIDE

Application Number

205141

Product Number

1

Dosage Form

-

Strength

0.25%

Approval Date

2021-02-11

Regulatory Status

RX

2021
11 Feb
RX Application: 205141

Drug Name

BUPIVACAINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

0.5%

Approval Date

2021-02-11

205141 / 2

Active Ingredient

BUPIVACAINE HYDROCHLORIDE

Application Number

205141

Product Number

2

Dosage Form

-

Strength

0.5%

Approval Date

2021-02-11

Regulatory Status

RX

2021
11 Feb
RX Application: 204842

Drug Name

BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE

Product Number

1

Dosage Form

-

Strength

0.25%

Approval Date

2021-02-11

204842 / 1

Active Ingredient

BUPIVACAINE HYDROCHLORIDE

Application Number

204842

Product Number

1

Dosage Form

-

Strength

0.25%

Approval Date

2021-02-11

Regulatory Status

RX

2021
11 Feb
RX Application: 204842

Drug Name

BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE

Product Number

2

Dosage Form

-

Strength

0.5%

Approval Date

2021-02-11

204842 / 2

Active Ingredient

BUPIVACAINE HYDROCHLORIDE

Application Number

204842

Product Number

2

Dosage Form

-

Strength

0.5%

Approval Date

2021-02-11

Regulatory Status

RX

2021
11 Feb
RX Application: 204842

Drug Name

BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE

Product Number

3

Dosage Form

-

Strength

0.75%

Approval Date

2021-02-11

204842 / 3

Active Ingredient

BUPIVACAINE HYDROCHLORIDE

Application Number

204842

Product Number

3

Dosage Form

-

Strength

0.75%

Approval Date

2021-02-11

Regulatory Status

RX

2005
02 Mar
RX Application: 76931

Drug Name

BUPRENORPHINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 0.3MG BASE/ML

Approval Date

2005-03-02

76931 / 1

Active Ingredient

BUPRENORPHINE HYDROCHLORIDE

Application Number

76931

Product Number

1

Dosage Form

-

Strength

EQ 0.3MG BASE/ML

Approval Date

2005-03-02

Regulatory Status

RX

2009
08 Oct
RX Application: 78633

Drug Name

BUPRENORPHINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2009-10-08

78633 / 1

Active Ingredient

BUPRENORPHINE HYDROCHLORIDE

Application Number

78633

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2009-10-08

Regulatory Status

RX

2009
08 Oct
RX Application: 78633

Drug Name

BUPRENORPHINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 8MG BASE

Approval Date

2009-10-08

78633 / 2

Active Ingredient

BUPRENORPHINE HYDROCHLORIDE

Application Number

78633

Product Number

2

Dosage Form

-

Strength

EQ 8MG BASE

Approval Date

2009-10-08

Regulatory Status

RX

2014
27 Jun
RX Application: 203326

Drug Name

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE;EQ 0.5MG BASE

Approval Date

2014-06-27

203326 / 1

Active Ingredient

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Application Number

203326

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE;EQ 0.5MG BASE

Approval Date

2014-06-27

Regulatory Status

RX

2014
27 Jun
RX Application: 203326

Drug Name

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 8MG BASE;EQ 2MG BASE

Approval Date

2014-06-27

203326 / 2

Active Ingredient

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Application Number

203326

Product Number

2

Dosage Form

-

Strength

EQ 8MG BASE;EQ 2MG BASE

Approval Date

2014-06-27

Regulatory Status

RX

1998
28 Oct
Discontinued Application: 40261

Drug Name

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

Product Number

1

Dosage Form

-

Strength

500MG;50MG;40MG

Approval Date

1998-10-28

40261 / 1

Active Ingredient

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

Application Number

40261

Product Number

1

Dosage Form

-

Strength

500MG;50MG;40MG

Approval Date

1998-10-28

Regulatory Status

Discontinued

1999
18 Aug
Discontinued Application: 40336

Drug Name

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

Product Number

1

Dosage Form

-

Strength

500MG;50MG;40MG

Approval Date

1999-08-18

40336 / 1

Active Ingredient

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

Application Number

40336

Product Number

1

Dosage Form

-

Strength

500MG;50MG;40MG

Approval Date

1999-08-18

Regulatory Status

Discontinued

1995
12 Jun
Discontinued Application: 89718

Drug Name

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

Product Number

1

Dosage Form

-

Strength

325MG;50MG;40MG

Approval Date

1995-06-12

89718 / 1

Active Ingredient

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

Application Number

89718

Product Number

1

Dosage Form

-

Strength

325MG;50MG;40MG

Approval Date

1995-06-12

Regulatory Status

Discontinued

2022
25 Mar
Discontinued Application: 215135

Drug Name

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

Product Number

1

Dosage Form

-

Strength

300MG;50MG;40MG

Approval Date

2022-03-25

215135 / 1

Active Ingredient

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

Application Number

215135

Product Number

1

Dosage Form

-

Strength

300MG;50MG;40MG

Approval Date

2022-03-25

Regulatory Status

Discontinued

2022
25 Mar
Discontinued Application: 215135

Drug Name

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

Product Number

2

Dosage Form

-

Strength

325MG;50MG;40MG

Approval Date

2022-03-25

215135 / 2

Active Ingredient

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

Application Number

215135

Product Number

2

Dosage Form

-

Strength

325MG;50MG;40MG

Approval Date

2022-03-25

Regulatory Status

Discontinued

2001
23 Mar
Discontinued Application: 75618

Drug Name

BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

325MG;50MG;40MG;30MG

Approval Date

2001-03-23

75618 / 1

Active Ingredient

ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE

Application Number

75618

Product Number

1

Dosage Form

-

Strength

325MG;50MG;40MG;30MG

Approval Date

2001-03-23

Regulatory Status

Discontinued

2022
26 Jan
RX Application: 215138

Drug Name

BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

325MG;50MG;40MG;30MG

Approval Date

2022-01-26

215138 / 1

Active Ingredient

ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE

Application Number

215138

Product Number

1

Dosage Form

-

Strength

325MG;50MG;40MG;30MG

Approval Date

2022-01-26

Regulatory Status

RX

2022
26 Jan
RX Application: 215138

Drug Name

BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE

Product Number

2

Dosage Form

-

Strength

300MG;50MG;40MG;30MG

Approval Date

2022-01-26

215138 / 2

Active Ingredient

ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE

Application Number

215138

Product Number

2

Dosage Form

-

Strength

300MG;50MG;40MG;30MG

Approval Date

2022-01-26

Regulatory Status

RX

1984
16 Feb
Discontinued Application: 86162

Drug Name

BUTALBITAL, ASPIRIN AND CAFFEINE

Product Number

2

Dosage Form

-

Strength

325MG;50MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1984-02-16

86162 / 2

Active Ingredient

ASPIRIN; BUTALBITAL; CAFFEINE

Application Number

86162

Product Number

2

Dosage Form

-

Strength

325MG;50MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1984-02-16

Regulatory Status

Discontinued

1998
12 Aug
RX Application: 75046

Drug Name

BUTORPHANOL TARTRATE

Product Number

1

Dosage Form

-

Strength

2MG/ML

Approval Date

1998-08-12

75046 / 1

Active Ingredient

BUTORPHANOL TARTRATE

Application Number

75046

Product Number

1

Dosage Form

-

Strength

2MG/ML

Approval Date

1998-08-12

Regulatory Status

RX

2002
12 Mar
RX Application: 75824

Drug Name

BUTORPHANOL TARTRATE

Product Number

1

Dosage Form

-

Strength

1MG/SPRAY

Approval Date

2002-03-12

75824 / 1

Active Ingredient

BUTORPHANOL TARTRATE

Application Number

75824

Product Number

1

Dosage Form

-

Strength

1MG/SPRAY

Approval Date

2002-03-12

Regulatory Status

RX

2009
29 Apr
Discontinued Application: 78247

Drug Name

BUTORPHANOL TARTRATE

Product Number

1

Dosage Form

-

Strength

2MG/ML

Approval Date

2009-04-29

78247 / 1

Active Ingredient

BUTORPHANOL TARTRATE

Application Number

78247

Product Number

1

Dosage Form

-

Strength

2MG/ML

Approval Date

2009-04-29

Regulatory Status

Discontinued

2009
01 May
RX Application: 78400

Drug Name

BUTORPHANOL TARTRATE

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2009-05-01

78400 / 1

Active Ingredient

BUTORPHANOL TARTRATE

Application Number

78400

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2009-05-01

Regulatory Status

RX

2009
01 May
RX Application: 78400

Drug Name

BUTORPHANOL TARTRATE

Product Number

2

Dosage Form

-

Strength

2MG/ML

Approval Date

2009-05-01

78400 / 2

Active Ingredient

BUTORPHANOL TARTRATE

Application Number

78400

Product Number

2

Dosage Form

-

Strength

2MG/ML

Approval Date

2009-05-01

Regulatory Status

RX

1998
12 Aug
RX Application: 75045

Drug Name

BUTORPHANOL TARTRATE PRESERVATIVE FREE

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

1998-08-12

75045 / 1

Active Ingredient

BUTORPHANOL TARTRATE

Application Number

75045

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

1998-08-12

Regulatory Status

RX

1998
12 Aug
RX Application: 75045

Drug Name

BUTORPHANOL TARTRATE PRESERVATIVE FREE

Product Number

2

Dosage Form

-

Strength

2MG/ML

Approval Date

1998-08-12

75045 / 2

Active Ingredient

BUTORPHANOL TARTRATE

Application Number

75045

Product Number

2

Dosage Form

-

Strength

2MG/ML

Approval Date

1998-08-12

Regulatory Status

RX

1999
21 Sep
RX Application: 20793

Drug Name

CAFCIT

Product Number

1

Dosage Form

-

Strength

EQ 30MG BASE/3ML (EQ 10MG BASE/ML)

Approval Date

1999-09-21

20793 / 1

Active Ingredient

CAFFEINE CITRATE

Application Number

20793

Product Number

1

Dosage Form

-

Strength

EQ 30MG BASE/3ML (EQ 10MG BASE/ML)

Approval Date

1999-09-21

Regulatory Status

RX

2000
12 Apr
Discontinued Application: 20793

Drug Name

CAFCIT

Product Number

2

Dosage Form

-

Strength

EQ 30MG BASE/3ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2000-04-12

20793 / 2

Active Ingredient

CAFFEINE CITRATE

Application Number

20793

Product Number

2

Dosage Form

-

Strength

EQ 30MG BASE/3ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2000-04-12

Regulatory Status

Discontinued

2009
19 Nov
Discontinued Application: 77579

Drug Name

CALCIPOTRIENE

Product Number

1

Dosage Form

-

Strength

0.005%

Approval Date

2009-11-19

77579 / 1

Active Ingredient

CALCIPOTRIENE

Application Number

77579

Product Number

1

Dosage Form

-

Strength

0.005%

Approval Date

2009-11-19

Regulatory Status

Discontinued

2003
18 Jul
RX Application: 76242

Drug Name

CALCITRIOL

Product Number

1

Dosage Form

-

Strength

1MCG/ML

Approval Date

2003-07-18

76242 / 1

Active Ingredient

CALCITRIOL

Application Number

76242

Product Number

1

Dosage Form

-

Strength

1MCG/ML

Approval Date

2003-07-18

Regulatory Status

RX

2006
27 Mar
RX Application: 76917

Drug Name

CALCITRIOL

Product Number

1

Dosage Form

-

Strength

0.25MCG

Approval Date

2006-03-27

76917 / 1

Active Ingredient

CALCITRIOL

Application Number

76917

Product Number

1

Dosage Form

-

Strength

0.25MCG

Approval Date

2006-03-27

Regulatory Status

RX

2008
30 Jan
Discontinued Application: 77693

Drug Name

CALCIUM ACETATE

Product Number

1

Dosage Form

-

Strength

667MG

Approval Date

2008-01-30

77693 / 1

Active Ingredient

CALCIUM ACETATE

Application Number

77693

Product Number

1

Dosage Form

-

Strength

667MG

Approval Date

2008-01-30

Regulatory Status

Discontinued

2008
26 Feb
RX Application: 77728

Drug Name

CALCIUM ACETATE

Product Number

1

Dosage Form

-

Strength

667MG

Approval Date

2008-02-26

77728 / 1

Active Ingredient

CALCIUM ACETATE

Application Number

77728

Product Number

1

Dosage Form

-

Strength

667MG

Approval Date

2008-02-26

Regulatory Status

RX

2016
14 Jul
Discontinued Application: 200483

Drug Name

CAPECITABINE

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2016-07-14

200483 / 1

Active Ingredient

CAPECITABINE

Application Number

200483

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2016-07-14

Regulatory Status

Discontinued

2016
14 Jul
Discontinued Application: 200483

Drug Name

CAPECITABINE

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2016-07-14

200483 / 2

Active Ingredient

CAPECITABINE

Application Number

200483

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2016-07-14

Regulatory Status

Discontinued

1996
13 Feb
RX Application: 74505

Drug Name

CAPTOPRIL

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

1996-02-13

74505 / 1

Active Ingredient

CAPTOPRIL

Application Number

74505

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

1996-02-13

Regulatory Status

RX

1996
13 Feb
RX Application: 74505

Drug Name

CAPTOPRIL

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

1996-02-13

74505 / 2

Active Ingredient

CAPTOPRIL

Application Number

74505

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

1996-02-13

Regulatory Status

RX

1996
13 Feb
RX Application: 74505

Drug Name

CAPTOPRIL

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

1996-02-13

74505 / 3

Active Ingredient

CAPTOPRIL

Application Number

74505

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

1996-02-13

Regulatory Status

RX

1996
13 Feb
RX Application: 74505

Drug Name

CAPTOPRIL

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

1996-02-13

74505 / 4

Active Ingredient

CAPTOPRIL

Application Number

74505

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

1996-02-13

Regulatory Status

RX

2004
14 Oct
Discontinued Application: 76099

Drug Name

CARBOPLATIN

Product Number

1

Dosage Form

-

Strength

50MG/VIAL

Approval Date

2004-10-14

76099 / 1

Active Ingredient

CARBOPLATIN

Application Number

76099

Product Number

1

Dosage Form

-

Strength

50MG/VIAL

Approval Date

2004-10-14

Regulatory Status

Discontinued

2004
14 Oct
Discontinued Application: 76099

Drug Name

CARBOPLATIN

Product Number

2

Dosage Form

-

Strength

150MG/VIAL

Approval Date

2004-10-14

76099 / 2

Active Ingredient

CARBOPLATIN

Application Number

76099

Product Number

2

Dosage Form

-

Strength

150MG/VIAL

Approval Date

2004-10-14

Regulatory Status

Discontinued

2004
14 Oct
Discontinued Application: 76099

Drug Name

CARBOPLATIN

Product Number

3

Dosage Form

-

Strength

450MG/VIAL

Approval Date

2004-10-14

76099 / 3

Active Ingredient

CARBOPLATIN

Application Number

76099

Product Number

3

Dosage Form

-

Strength

450MG/VIAL

Approval Date

2004-10-14

Regulatory Status

Discontinued

2004
15 Oct
RX Application: 77244

Drug Name

CARBOPLATIN

Product Number

1

Dosage Form

-

Strength

50MG/5ML (10MG/ML)

Approval Date

2004-10-15

77244 / 1

Active Ingredient

CARBOPLATIN

Application Number

77244

Product Number

1

Dosage Form

-

Strength

50MG/5ML (10MG/ML)

Approval Date

2004-10-15

Regulatory Status

RX

2004
15 Oct
RX Application: 77244

Drug Name

CARBOPLATIN

Product Number

2

Dosage Form

-

Strength

150MG/15ML (10MG/ML)

Approval Date

2004-10-15

77244 / 2

Active Ingredient

CARBOPLATIN

Application Number

77244

Product Number

2

Dosage Form

-

Strength

150MG/15ML (10MG/ML)

Approval Date

2004-10-15

Regulatory Status

RX

2004
15 Oct
RX Application: 77244

Drug Name

CARBOPLATIN

Product Number

3

Dosage Form

-

Strength

450MG/45ML (10MG/ML)

Approval Date

2004-10-15

77244 / 3

Active Ingredient

CARBOPLATIN

Application Number

77244

Product Number

3

Dosage Form

-

Strength

450MG/45ML (10MG/ML)

Approval Date

2004-10-15

Regulatory Status

RX

2006
20 Jan
RX Application: 77244

Drug Name

CARBOPLATIN

Product Number

4

Dosage Form

-

Strength

600MG/60ML (10MG/ML)

Approval Date

2006-01-20

77244 / 4

Active Ingredient

CARBOPLATIN

Application Number

77244

Product Number

4

Dosage Form

-

Strength

600MG/60ML (10MG/ML)

Approval Date

2006-01-20

Regulatory Status

RX

1996
24 Jan
Discontinued Application: 40124

Drug Name

CARISOPRODOL

Product Number

1

Dosage Form

-

Strength

350MG

Approval Date

1996-01-24

40124 / 1

Active Ingredient

CARISOPRODOL

Application Number

40124

Product Number

1

Dosage Form

-

Strength

350MG

Approval Date

1996-01-24

Regulatory Status

Discontinued

2007
07 Sep
Discontinued Application: 77887

Drug Name

CARVEDILOL

Product Number

1

Dosage Form

-

Strength

3.125MG

Approval Date

2007-09-07

77887 / 1

Active Ingredient

CARVEDILOL

Application Number

77887

Product Number

1

Dosage Form

-

Strength

3.125MG

Approval Date

2007-09-07

Regulatory Status

Discontinued

2007
07 Sep
Discontinued Application: 77887

Drug Name

CARVEDILOL

Product Number

2

Dosage Form

-

Strength

6.25MG

Approval Date

2007-09-07

77887 / 2

Active Ingredient

CARVEDILOL

Application Number

77887

Product Number

2

Dosage Form

-

Strength

6.25MG

Approval Date

2007-09-07

Regulatory Status

Discontinued

2007
07 Sep
Discontinued Application: 77887

Drug Name

CARVEDILOL

Product Number

3

Dosage Form

-

Strength

12.5MG

Approval Date

2007-09-07

77887 / 3

Active Ingredient

CARVEDILOL

Application Number

77887

Product Number

3

Dosage Form

-

Strength

12.5MG

Approval Date

2007-09-07

Regulatory Status

Discontinued

2007
07 Sep
Discontinued Application: 77887

Drug Name

CARVEDILOL

Product Number

4

Dosage Form

-

Strength

25MG

Approval Date

2007-09-07

77887 / 4

Active Ingredient

CARVEDILOL

Application Number

77887

Product Number

4

Dosage Form

-

Strength

25MG

Approval Date

2007-09-07

Regulatory Status

Discontinued

2007
03 Apr
Discontinued Application: 65350

Drug Name

CEFACLOR

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2007-04-03

65350 / 1

Active Ingredient

CEFACLOR

Application Number

65350

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2007-04-03

Regulatory Status

Discontinued

2007
03 Apr
Discontinued Application: 65350

Drug Name

CEFACLOR

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2007-04-03

65350 / 2

Active Ingredient

CEFACLOR

Application Number

65350

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2007-04-03

Regulatory Status

Discontinued

2006
30 Mar
Discontinued Application: 65260

Drug Name

CEFADROXIL

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE

Approval Date

2006-03-30

65260 / 1

Active Ingredient

CEFADROXIL/CEFADROXIL HEMIHYDRATE

Application Number

65260

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE

Approval Date

2006-03-30

Regulatory Status

Discontinued

2006
07 Feb
Discontinued Application: 65311

Drug Name

CEFADROXIL

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2006-02-07

65311 / 1

Active Ingredient

CEFADROXIL/CEFADROXIL HEMIHYDRATE

Application Number

65311

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2006-02-07

Regulatory Status

Discontinued

2012
28 Nov
Discontinued Application: 91036

Drug Name

CEFADROXIL

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE/5ML

Approval Date

2012-11-28

91036 / 1

Active Ingredient

CEFADROXIL/CEFADROXIL HEMIHYDRATE

Application Number

91036

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE/5ML

Approval Date

2012-11-28

Regulatory Status

Discontinued

2012
28 Nov
Discontinued Application: 91036

Drug Name

CEFADROXIL

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/5ML

Approval Date

2012-11-28

91036 / 2

Active Ingredient

CEFADROXIL/CEFADROXIL HEMIHYDRATE

Application Number

91036

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/5ML

Approval Date

2012-11-28

Regulatory Status

Discontinued

1988
12 Jan
Discontinued Application: 62807

Drug Name

CEFAZOLIN SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE/VIAL

Approval Date

1988-01-12

62807 / 1

Active Ingredient

CEFAZOLIN SODIUM

Application Number

62807

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE/VIAL

Approval Date

1988-01-12

Regulatory Status

Discontinued

1988
12 Jan
Discontinued Application: 62807

Drug Name

CEFAZOLIN SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1988-01-12

62807 / 2

Active Ingredient

CEFAZOLIN SODIUM

Application Number

62807

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1988-01-12

Regulatory Status

Discontinued

1988
12 Jan
Discontinued Application: 62807

Drug Name

CEFAZOLIN SODIUM

Product Number

3

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1988-01-12

62807 / 3

Active Ingredient

CEFAZOLIN SODIUM

Application Number

62807

Product Number

3

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1988-01-12

Regulatory Status

Discontinued

1988
12 Jan
Discontinued Application: 62807

Drug Name

CEFAZOLIN SODIUM

Product Number

4

Dosage Form

-

Strength

EQ 5GM BASE/VIAL

Approval Date

1988-01-12

62807 / 4

Active Ingredient

CEFAZOLIN SODIUM

Application Number

62807

Product Number

4

Dosage Form

-

Strength

EQ 5GM BASE/VIAL

Approval Date

1988-01-12

Regulatory Status

Discontinued

1988
12 Jan
Discontinued Application: 62807

Drug Name

CEFAZOLIN SODIUM

Product Number

5

Dosage Form

-

Strength

EQ 10GM BASE/VIAL

Approval Date

1988-01-12

62807 / 5

Active Ingredient

CEFAZOLIN SODIUM

Application Number

62807

Product Number

5

Dosage Form

-

Strength

EQ 10GM BASE/VIAL

Approval Date

1988-01-12

Regulatory Status

Discontinued

1988
12 Jan
Discontinued Application: 62807

Drug Name

CEFAZOLIN SODIUM

Product Number

6

Dosage Form

-

Strength

EQ 20GM BASE/VIAL

Approval Date

1988-01-12

62807 / 6

Active Ingredient

CEFAZOLIN SODIUM

Application Number

62807

Product Number

6

Dosage Form

-

Strength

EQ 20GM BASE/VIAL

Approval Date

1988-01-12

Regulatory Status

Discontinued

2001
18 Sep
RX Application: 65047

Drug Name

CEFAZOLIN SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2001-09-18

65047 / 1

Active Ingredient

CEFAZOLIN SODIUM

Application Number

65047

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2001-09-18

Regulatory Status

RX

2001
18 Sep
RX Application: 65047

Drug Name

CEFAZOLIN SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2001-09-18

65047 / 2

Active Ingredient

CEFAZOLIN SODIUM

Application Number

65047

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2001-09-18

Regulatory Status

RX

2004
18 Oct
RX Application: 65143

Drug Name

CEFAZOLIN SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 10GM BASE/VIAL

Approval Date

2004-10-18

65143 / 1

Active Ingredient

CEFAZOLIN SODIUM

Application Number

65143

Product Number

1

Dosage Form

-

Strength

EQ 10GM BASE/VIAL

Approval Date

2004-10-18

Regulatory Status

RX

2022
07 Oct
RX Application: 216109

Drug Name

CEFAZOLIN SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

2022-10-07

216109 / 1

Active Ingredient

CEFAZOLIN SODIUM

Application Number

216109

Product Number

1

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

2022-10-07

Regulatory Status

RX

2022
07 Oct
RX Application: 216109

Drug Name

CEFAZOLIN SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 3GM BASE/VIAL

Approval Date

2022-10-07

216109 / 2

Active Ingredient

CEFAZOLIN SODIUM

Application Number

216109

Product Number

2

Dosage Form

-

Strength

EQ 3GM BASE/VIAL

Approval Date

2022-10-07

Regulatory Status

RX

2024
22 May
RX Application: 214402

Drug Name

CEFEPIME HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2024-05-22

214402 / 1

Active Ingredient

CEFEPIME HYDROCHLORIDE

Application Number

214402

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2024-05-22

Regulatory Status

RX

2024
22 May
RX Application: 214402

Drug Name

CEFEPIME HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

2024-05-22

214402 / 2

Active Ingredient

CEFEPIME HYDROCHLORIDE

Application Number

214402

Product Number

2

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

2024-05-22

Regulatory Status

RX

2002
20 Nov
Discontinued Application: 65071

Drug Name

CEFOTAXIME

Product Number

1

Dosage Form

-

Strength

EQ 10GM BASE/VIAL

Approval Date

2002-11-20

65071 / 1

Active Ingredient

CEFOTAXIME SODIUM

Application Number

65071

Product Number

1

Dosage Form

-

Strength

EQ 10GM BASE/VIAL

Approval Date

2002-11-20

Regulatory Status

Discontinued

2002
20 Nov
Discontinued Application: 65072

Drug Name

CEFOTAXIME

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2002-11-20

65072 / 1

Active Ingredient

CEFOTAXIME SODIUM

Application Number

65072

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2002-11-20

Regulatory Status

Discontinued

2002
20 Nov
Discontinued Application: 65072

Drug Name

CEFOTAXIME

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2002-11-20

65072 / 2

Active Ingredient

CEFOTAXIME SODIUM

Application Number

65072

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2002-11-20

Regulatory Status

Discontinued

2002
20 Nov
Discontinued Application: 65072

Drug Name

CEFOTAXIME

Product Number

3

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

2002-11-20

65072 / 3

Active Ingredient

CEFOTAXIME SODIUM

Application Number

65072

Product Number

3

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

2002-11-20

Regulatory Status

Discontinued

2011
26 Oct
Discontinued Application: 91031

Drug Name

CEFOTETAN

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2011-10-26

91031 / 1

Active Ingredient

CEFOTETAN DISODIUM

Application Number

91031

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2011-10-26

Regulatory Status

Discontinued

2011
26 Oct
Discontinued Application: 91031

Drug Name

CEFOTETAN

Product Number

2

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

2011-10-26

91031 / 2

Active Ingredient

CEFOTETAN DISODIUM

Application Number

91031

Product Number

2

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

2011-10-26

Regulatory Status

Discontinued

2000
11 Sep
RX Application: 65050

Drug Name

CEFOXITIN

Product Number

1

Dosage Form

-

Strength

EQ 10GM BASE/VIAL

Approval Date

2000-09-11

65050 / 1

Active Ingredient

CEFOXITIN SODIUM

Application Number

65050

Product Number

1

Dosage Form

-

Strength

EQ 10GM BASE/VIAL

Approval Date

2000-09-11

Regulatory Status

RX

2000
11 Sep
RX Application: 65051

Drug Name

CEFOXITIN

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2000-09-11

65051 / 1

Active Ingredient

CEFOXITIN SODIUM

Application Number

65051

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2000-09-11

Regulatory Status

RX

2000
11 Sep
RX Application: 65051

Drug Name

CEFOXITIN

Product Number

2

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

2000-09-11

65051 / 2

Active Ingredient

CEFOXITIN SODIUM

Application Number

65051

Product Number

2

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

2000-09-11

Regulatory Status

RX

2010
12 Mar
RX Application: 65238

Drug Name

CEFOXITIN

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2010-03-12

65238 / 1

Active Ingredient

CEFOXITIN SODIUM

Application Number

65238

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2010-03-12

Regulatory Status

RX

2010
12 Mar
RX Application: 65238

Drug Name

CEFOXITIN

Product Number

2

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

2010-03-12

65238 / 2

Active Ingredient

CEFOXITIN SODIUM

Application Number

65238

Product Number

2

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

2010-03-12

Regulatory Status

RX

2010
02 Mar
RX Application: 65239

Drug Name

CEFOXITIN

Product Number

1

Dosage Form

-

Strength

EQ 10GM BASE/VIAL

Approval Date

2010-03-02

65239 / 1

Active Ingredient

CEFOXITIN SODIUM

Application Number

65239

Product Number

1

Dosage Form

-

Strength

EQ 10GM BASE/VIAL

Approval Date

2010-03-02

Regulatory Status

RX

2008
10 Jan
RX Application: 65342

Drug Name

CEFTRIAXONE

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE/VIAL

Approval Date

2008-01-10

65342 / 1

Active Ingredient

CEFTRIAXONE SODIUM

Application Number

65342

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE/VIAL

Approval Date

2008-01-10

Regulatory Status

RX

2008
10 Jan
RX Application: 65342

Drug Name

CEFTRIAXONE

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2008-01-10

65342 / 2

Active Ingredient

CEFTRIAXONE SODIUM

Application Number

65342

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2008-01-10

Regulatory Status

RX

2008
10 Jan
RX Application: 65342

Drug Name

CEFTRIAXONE

Product Number

3

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2008-01-10

65342 / 3

Active Ingredient

CEFTRIAXONE SODIUM

Application Number

65342

Product Number

3

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2008-01-10

Regulatory Status

RX

2008
10 Jan
RX Application: 65342

Drug Name

CEFTRIAXONE

Product Number

4

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

2008-01-10

65342 / 4

Active Ingredient

CEFTRIAXONE SODIUM

Application Number

65342

Product Number

4

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

2008-01-10

Regulatory Status

RX

2017
04 Oct
RX Application: 90701

Drug Name

CEFTRIAXONE SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 10GM BASE/VIAL

Approval Date

2017-10-04

90701 / 1

Active Ingredient

CEFTRIAXONE SODIUM

Application Number

90701

Product Number

1

Dosage Form

-

Strength

EQ 10GM BASE/VIAL

Approval Date

2017-10-04

Regulatory Status

RX

-
Unclassified Application: 65048

Drug Name

CEFUROXIME

Product Number

3

Dosage Form

-

Strength

1.5G/20ML

Approval Date

-

65048 / 3

Active Ingredient

CEFUROXIME

Application Number

65048

Product Number

3

Dosage Form

-

Strength

1.5G/20ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 65048

Drug Name

CEFUROXIME

Product Number

4

Dosage Form

-

Strength

1.5G/100ML

Approval Date

-

65048 / 4

Active Ingredient

CEFUROXIME

Application Number

65048

Product Number

4

Dosage Form

-

Strength

1.5G/100ML

Approval Date

-

Regulatory Status

Unclassified

2004
09 Jan
Discontinued Application: 65046

Drug Name

CEFUROXIME SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 7.5GM BASE/VIAL

Approval Date

2004-01-09

65046 / 1

Active Ingredient

CEFUROXIME SODIUM

Application Number

65046

Product Number

1

Dosage Form

-

Strength

EQ 7.5GM BASE/VIAL

Approval Date

2004-01-09

Regulatory Status

Discontinued

2004
09 Jan
RX Application: 65048

Drug Name

CEFUROXIME SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 750MG BASE/VIAL

Approval Date

2004-01-09

65048 / 1

Active Ingredient

CEFUROXIME SODIUM

Application Number

65048

Product Number

1

Dosage Form

-

Strength

EQ 750MG BASE/VIAL

Approval Date

2004-01-09

Regulatory Status

RX

2004
09 Jan
RX Application: 65048

Drug Name

CEFUROXIME SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 1.5GM BASE/VIAL

Approval Date

2004-01-09

65048 / 2

Active Ingredient

CEFUROXIME SODIUM

Application Number

65048

Product Number

2

Dosage Form

-

Strength

EQ 1.5GM BASE/VIAL

Approval Date

2004-01-09

Regulatory Status

RX

2006
24 Jan
Discontinued Application: 65215

Drug Name

CEPHALEXIN

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2006-01-24

65215 / 1

Active Ingredient

CEPHALEXIN

Application Number

65215

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2006-01-24

Regulatory Status

Discontinued

2006
24 Jan
Discontinued Application: 65215

Drug Name

CEPHALEXIN

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2006-01-24

65215 / 2

Active Ingredient

CEPHALEXIN

Application Number

65215

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2006-01-24

Regulatory Status

Discontinued

2009
28 Aug
Discontinued Application: 65444

Drug Name

CEPHALEXIN

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE/5ML

Approval Date

2009-08-28

65444 / 1

Active Ingredient

CEPHALEXIN

Application Number

65444

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE/5ML

Approval Date

2009-08-28

Regulatory Status

Discontinued

2009
28 Aug
Discontinued Application: 65444

Drug Name

CEPHALEXIN

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE/5ML

Approval Date

2009-08-28

65444 / 2

Active Ingredient

CEPHALEXIN

Application Number

65444

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE/5ML

Approval Date

2009-08-28

Regulatory Status

Discontinued

1987
02 Jul
Discontinued Application: 62720

Drug Name

CEPHAPIRIN SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1987-07-02

62720 / 1

Active Ingredient

CEPHAPIRIN SODIUM

Application Number

62720

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1987-07-02

Regulatory Status

Discontinued

1987
02 Jul
Discontinued Application: 62720

Drug Name

CEPHAPIRIN SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1987-07-02

62720 / 2

Active Ingredient

CEPHAPIRIN SODIUM

Application Number

62720

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1987-07-02

Regulatory Status

Discontinued

1987
02 Jul
Discontinued Application: 62720

Drug Name

CEPHAPIRIN SODIUM

Product Number

3

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

1987-07-02

62720 / 3

Active Ingredient

CEPHAPIRIN SODIUM

Application Number

62720

Product Number

3

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

1987-07-02

Regulatory Status

Discontinued

1987
02 Jul
Discontinued Application: 62720

Drug Name

CEPHAPIRIN SODIUM

Product Number

4

Dosage Form

-

Strength

EQ 20GM BASE/VIAL

Approval Date

1987-07-02

62720 / 4

Active Ingredient

CEPHAPIRIN SODIUM

Application Number

62720

Product Number

4

Dosage Form

-

Strength

EQ 20GM BASE/VIAL

Approval Date

1987-07-02

Regulatory Status

Discontinued

1995
03 Feb
RX Application: 64103

Drug Name

CERUBIDINE

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE/VIAL

Approval Date

1995-02-03

64103 / 1

Active Ingredient

DAUNORUBICIN HYDROCHLORIDE

Application Number

64103

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE/VIAL

Approval Date

1995-02-03

Regulatory Status

RX

2013
08 Jul
RX Application: 91591

Drug Name

CEVIMELINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

2013-07-08

91591 / 1

Active Ingredient

CEVIMELINE HYDROCHLORIDE

Application Number

91591

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

2013-07-08

Regulatory Status

RX

1998
09 Sep
RX Application: 40273

Drug Name

CHLOROPROCAINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1998-09-09

40273 / 1

Active Ingredient

CHLOROPROCAINE HYDROCHLORIDE

Application Number

40273

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1998-09-09

Regulatory Status

RX

1998
09 Sep
RX Application: 40273

Drug Name

CHLOROPROCAINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

3%

Approval Date

1998-09-09

40273 / 2

Active Ingredient

CHLOROPROCAINE HYDROCHLORIDE

Application Number

40273

Product Number

2

Dosage Form

-

Strength

3%

Approval Date

1998-09-09

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 83082

Drug Name

CHLOROQUINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

83082 / 1

Active Ingredient

CHLOROQUINE PHOSPHATE

Application Number

83082

Product Number

1

Dosage Form

-

Strength

250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1999
17 Sep
Discontinued Application: 83082

Drug Name

CHLOROQUINE PHOSPHATE

Product Number

2

Dosage Form

-

Strength

500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1999-09-17

83082 / 2

Active Ingredient

CHLOROQUINE PHOSPHATE

Application Number

83082

Product Number

2

Dosage Form

-

Strength

500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1999-09-17

Regulatory Status

Discontinued

1982
14 Jul
Discontinued Application: 86028

Drug Name

CHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1982-07-14

86028 / 1

Active Ingredient

CHLOROTHIAZIDE

Application Number

86028

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1982-07-14

Regulatory Status

Discontinued

1982
14 Jul
Discontinued Application: 87736

Drug Name

CHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1982-07-14

87736 / 1

Active Ingredient

CHLOROTHIAZIDE

Application Number

87736

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1982-07-14

Regulatory Status

Discontinued

1983
22 Dec
Discontinued Application: 88365

Drug Name

CHLOROTHIAZIDE AND RESERPINE

Product Number

1

Dosage Form

-

Strength

500MG;0.125MG

Approval Date

1983-12-22

88365 / 1

Active Ingredient

CHLOROTHIAZIDE; RESERPINE

Application Number

88365

Product Number

1

Dosage Form

-

Strength

500MG;0.125MG

Approval Date

1983-12-22

Regulatory Status

Discontinued

1983
22 Dec
Discontinued Application: 88365

Drug Name

CHLOROTHIAZIDE AND RESERPINE

Product Number

2

Dosage Form

-

Strength

250MG;0.125MG

Approval Date

1983-12-22

88365 / 2

Active Ingredient

CHLOROTHIAZIDE; RESERPINE

Application Number

88365

Product Number

2

Dosage Form

-

Strength

250MG;0.125MG

Approval Date

1983-12-22

Regulatory Status

Discontinued

-
Unclassified Application: 88557

Drug Name

CHLOROTHIAZIDE AND RESERPINE

Product Number

1

Dosage Form

-

Strength

250MG;0.125MG

Approval Date

-

88557 / 1

Active Ingredient

CHLOROTHIAZIDE; RESERPINE

Application Number

88557

Product Number

1

Dosage Form

-

Strength

250MG;0.125MG

Approval Date

-

Regulatory Status

Unclassified

1982
01 Jan
RX Application: 83329

Drug Name

CHLORPROMAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG/ML

Approval Date

1982-01-01

83329 / 1

Active Ingredient

CHLORPROMAZINE HYDROCHLORIDE

Application Number

83329

Product Number

1

Dosage Form

-

Strength

25MG/ML

Approval Date

1982-01-01

Regulatory Status

RX

1983
27 Apr
Discontinued Application: 88157

Drug Name

CHLORPROMAZINE HYDROCHLORIDE INTENSOL

Product Number

1

Dosage Form

-

Strength

30MG/ML

Approval Date

1983-04-27

88157 / 1

Active Ingredient

CHLORPROMAZINE HYDROCHLORIDE

Application Number

88157

Product Number

1

Dosage Form

-

Strength

30MG/ML

Approval Date

1983-04-27

Regulatory Status

Discontinued

1983
27 Apr
Discontinued Application: 88158

Drug Name

CHLORPROMAZINE HYDROCHLORIDE INTENSOL

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

1983-04-27

88158 / 1

Active Ingredient

CHLORPROMAZINE HYDROCHLORIDE

Application Number

88158

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

1983-04-27

Regulatory Status

Discontinued

2007
18 Sep
Discontinued Application: 78270

Drug Name

CICLOPIROX

Product Number

1

Dosage Form

-

Strength

8%

Approval Date

2007-09-18

78270 / 1

Active Ingredient

CICLOPIROX

Application Number

78270

Product Number

1

Dosage Form

-

Strength

8%

Approval Date

2007-09-18

Regulatory Status

Discontinued

2005
17 May
Discontinued Application: 77024

Drug Name

CILOSTAZOL

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2005-05-17

77024 / 1

Active Ingredient

CILOSTAZOL

Application Number

77024

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2005-05-17

Regulatory Status

Discontinued

2005
17 May
Discontinued Application: 77024

Drug Name

CILOSTAZOL

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2005-05-17

77024 / 2

Active Ingredient

CILOSTAZOL

Application Number

77024

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2005-05-17

Regulatory Status

Discontinued

1998
18 Dec
Discontinued Application: 74890

Drug Name

CIMETIDINE

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1998-12-18

74890 / 1

Active Ingredient

CIMETIDINE

Application Number

74890

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1998-12-18

Regulatory Status

Discontinued

1998
18 Dec
Discontinued Application: 74890

Drug Name

CIMETIDINE

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

1998-12-18

74890 / 2

Active Ingredient

CIMETIDINE

Application Number

74890

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

1998-12-18

Regulatory Status

Discontinued

1998
18 Dec
Discontinued Application: 74890

Drug Name

CIMETIDINE

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

1998-12-18

74890 / 3

Active Ingredient

CIMETIDINE

Application Number

74890

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

1998-12-18

Regulatory Status

Discontinued

1998
18 Dec
Discontinued Application: 74890

Drug Name

CIMETIDINE

Product Number

4

Dosage Form

-

Strength

800MG

Approval Date

1998-12-18

74890 / 4

Active Ingredient

CIMETIDINE

Application Number

74890

Product Number

4

Dosage Form

-

Strength

800MG

Approval Date

1998-12-18

Regulatory Status

Discontinued

-
Unclassified Application: 76558

Drug Name

CIPROFLOXACIN

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

-

76558 / 1

Active Ingredient

CIPROFLOXACIN

Application Number

76558

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

-

Regulatory Status

Unclassified

2009
22 Dec
RX Application: 76717

Drug Name

CIPROFLOXACIN

Product Number

1

Dosage Form

-

Strength

200MG/20ML (10MG/ML)

Approval Date

2009-12-22

76717 / 1

Active Ingredient

CIPROFLOXACIN

Application Number

76717

Product Number

1

Dosage Form

-

Strength

200MG/20ML (10MG/ML)

Approval Date

2009-12-22

Regulatory Status

RX

2009
22 Dec
RX Application: 76717

Drug Name

CIPROFLOXACIN

Product Number

2

Dosage Form

-

Strength

400MG/40ML (10MG/ML)

Approval Date

2009-12-22

76717 / 2

Active Ingredient

CIPROFLOXACIN

Application Number

76717

Product Number

2

Dosage Form

-

Strength

400MG/40ML (10MG/ML)

Approval Date

2009-12-22

Regulatory Status

RX

2004
09 Jun
Discontinued Application: 76558

Drug Name

CIPROFLOXACIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2004-06-09

76558 / 2

Active Ingredient

CIPROFLOXACIN HYDROCHLORIDE

Application Number

76558

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2004-06-09

Regulatory Status

Discontinued

2004
09 Jun
Discontinued Application: 76558

Drug Name

CIPROFLOXACIN HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2004-06-09

76558 / 3

Active Ingredient

CIPROFLOXACIN HYDROCHLORIDE

Application Number

76558

Product Number

3

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2004-06-09

Regulatory Status

Discontinued

2004
09 Jun
Discontinued Application: 76558

Drug Name

CIPROFLOXACIN HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 750MG BASE

Approval Date

2004-06-09

76558 / 4

Active Ingredient

CIPROFLOXACIN HYDROCHLORIDE

Application Number

76558

Product Number

4

Dosage Form

-

Strength

EQ 750MG BASE

Approval Date

2004-06-09

Regulatory Status

Discontinued

2008
21 Apr
Discontinued Application: 76757

Drug Name

CIPROFLOXACIN IN DEXTROSE 5%

Product Number

1

Dosage Form

-

Strength

200MG/100ML

Approval Date

2008-04-21

76757 / 1

Active Ingredient

CIPROFLOXACIN

Application Number

76757

Product Number

1

Dosage Form

-

Strength

200MG/100ML

Approval Date

2008-04-21

Regulatory Status

Discontinued

2009
18 Nov
RX Application: 78431

Drug Name

CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

400MG/200ML

Approval Date

2009-11-18

78431 / 1

Active Ingredient

CIPROFLOXACIN

Application Number

78431

Product Number

1

Dosage Form

-

Strength

400MG/200ML

Approval Date

2009-11-18

Regulatory Status

RX

2022
28 Jun
RX Application: 203078

Drug Name

CISATRACURIUM BESYLATE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2022-06-28

203078 / 1

Active Ingredient

CISATRACURIUM BESYLATE

Application Number

203078

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2022-06-28

Regulatory Status

RX

2023
18 Dec
RX Application: 203078

Drug Name

CISATRACURIUM BESYLATE

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

2023-12-18

203078 / 2

Active Ingredient

CISATRACURIUM BESYLATE

Application Number

203078

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

2023-12-18

Regulatory Status

RX

2023
19 Apr
RX Application: 203079

Drug Name

CISATRACURIUM BESYLATE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2023-04-19

203079 / 1

Active Ingredient

CISATRACURIUM BESYLATE

Application Number

203079

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2023-04-19

Regulatory Status

RX

2000
07 Nov
RX Application: 75036

Drug Name

CISPLATIN

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2000-11-07

75036 / 1

Active Ingredient

CISPLATIN

Application Number

75036

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2000-11-07

Regulatory Status

RX

2004
13 Dec
RX Application: 77043

Drug Name

CITALOPRAM HYDROBROMIDE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/5ML

Approval Date

2004-12-13

77043 / 1

Active Ingredient

CITALOPRAM HYDROBROMIDE

Application Number

77043

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/5ML

Approval Date

2004-12-13

Regulatory Status

RX

2000
28 Feb
RX Application: 75405

Drug Name

CLADRIBINE

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2000-02-28

75405 / 1

Active Ingredient

CLADRIBINE

Application Number

75405

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2000-02-28

Regulatory Status

RX

2004
25 May
Discontinued Application: 65178

Drug Name

CLARITHROMYCIN

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2004-05-25

65178 / 1

Active Ingredient

CLARITHROMYCIN

Application Number

65178

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2004-05-25

Regulatory Status

Discontinued

2004
25 May
Discontinued Application: 65178

Drug Name

CLARITHROMYCIN

Product Number

2

Dosage Form

-

Strength

250MG

Approval Date

2004-05-25

65178 / 2

Active Ingredient

CLARITHROMYCIN

Application Number

65178

Product Number

2

Dosage Form

-

Strength

250MG

Approval Date

2004-05-25

Regulatory Status

Discontinued

1987
15 Oct
Discontinued Application: 62806

Drug Name

CLINDAMYCIN PHOSPHATE

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE/ML

Approval Date

1987-10-15

62806 / 1

Active Ingredient

CLINDAMYCIN PHOSPHATE

Application Number

62806

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE/ML

Approval Date

1987-10-15

Regulatory Status

Discontinued

1988
25 Apr
RX Application: 62889

Drug Name

CLINDAMYCIN PHOSPHATE

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE/ML

Approval Date

1988-04-25

62889 / 1

Active Ingredient

CLINDAMYCIN PHOSPHATE

Application Number

62889

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE/ML

Approval Date

1988-04-25

Regulatory Status

RX

1988
21 Apr
Discontinued Application: 62953

Drug Name

CLINDAMYCIN PHOSPHATE

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE/ML

Approval Date

1988-04-21

62953 / 1

Active Ingredient

CLINDAMYCIN PHOSPHATE

Application Number

62953

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE/ML

Approval Date

1988-04-21

Regulatory Status

Discontinued

1989
28 Aug
Discontinued Application: 63068

Drug Name

CLINDAMYCIN PHOSPHATE

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE/ML

Approval Date

1989-08-28

63068 / 1

Active Ingredient

CLINDAMYCIN PHOSPHATE

Application Number

63068

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE/ML

Approval Date

1989-08-28

Regulatory Status

Discontinued

2004
24 Sep
RX Application: 65206

Drug Name

CLINDAMYCIN PHOSPHATE

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE/ML

Approval Date

2004-09-24

65206 / 1

Active Ingredient

CLINDAMYCIN PHOSPHATE

Application Number

65206

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE/ML

Approval Date

2004-09-24

Regulatory Status

RX

2023
05 Apr
RX Application: 214401

Drug Name

CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%

Product Number

1

Dosage Form

-

Strength

EQ 6MG BASE/ML

Approval Date

2023-04-05

214401 / 1

Active Ingredient

CLINDAMYCIN PHOSPHATE

Application Number

214401

Product Number

1

Dosage Form

-

Strength

EQ 6MG BASE/ML

Approval Date

2023-04-05

Regulatory Status

RX

2023
05 Apr
RX Application: 214401

Drug Name

CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%

Product Number

2

Dosage Form

-

Strength

EQ 12MG BASE/ML

Approval Date

2023-04-05

214401 / 2

Active Ingredient

CLINDAMYCIN PHOSPHATE

Application Number

214401

Product Number

2

Dosage Form

-

Strength

EQ 12MG BASE/ML

Approval Date

2023-04-05

Regulatory Status

RX

2023
05 Apr
RX Application: 214401

Drug Name

CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%

Product Number

3

Dosage Form

-

Strength

EQ 18MG BASE/ML

Approval Date

2023-04-05

214401 / 3

Active Ingredient

CLINDAMYCIN PHOSPHATE

Application Number

214401

Product Number

3

Dosage Form

-

Strength

EQ 18MG BASE/ML

Approval Date

2023-04-05

Regulatory Status

RX

2018
22 Oct
Discontinued Application: 208785

Drug Name

CLOBAZAM

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2018-10-22

208785 / 1

Active Ingredient

CLOBAZAM

Application Number

208785

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2018-10-22

Regulatory Status

Discontinued

2018
22 Oct
Discontinued Application: 208785

Drug Name

CLOBAZAM

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2018-10-22

208785 / 2

Active Ingredient

CLOBAZAM

Application Number

208785

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2018-10-22

Regulatory Status

Discontinued

2018
22 Oct
Discontinued Application: 209715

Drug Name

CLOBAZAM

Product Number

1

Dosage Form

-

Strength

2.5MG/ML

Approval Date

2018-10-22

209715 / 1

Active Ingredient

CLOBAZAM

Application Number

209715

Product Number

1

Dosage Form

-

Strength

2.5MG/ML

Approval Date

2018-10-22

Regulatory Status

Discontinued

2017
27 Oct
Discontinued Application: 209871

Drug Name

CLOBETASOL PROPIONATE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2017-10-27

209871 / 1

Active Ingredient

CLOBETASOL PROPIONATE

Application Number

209871

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2017-10-27

Regulatory Status

Discontinued

2011
26 Jan
RX Application: 200300

Drug Name

CLONIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

1MG/10ML (0.1MG/ML)

Approval Date

2011-01-26

200300 / 1

Active Ingredient

CLONIDINE HYDROCHLORIDE

Application Number

200300

Product Number

1

Dosage Form

-

Strength

1MG/10ML (0.1MG/ML)

Approval Date

2011-01-26

Regulatory Status

RX

2011
26 Jan
RX Application: 200300

Drug Name

CLONIDINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

5MG/10ML (0.5MG/ML)

Approval Date

2011-01-26

200300 / 2

Active Ingredient

CLONIDINE HYDROCHLORIDE

Application Number

200300

Product Number

2

Dosage Form

-

Strength

5MG/10ML (0.5MG/ML)

Approval Date

2011-01-26

Regulatory Status

RX

2004
29 Jul
RX Application: 76387

Drug Name

CLOTRIMAZOLE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2004-07-29

76387 / 1

Active Ingredient

CLOTRIMAZOLE

Application Number

76387

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2004-07-29

Regulatory Status

RX

2009
16 Jul
RX Application: 22402

Drug Name

CODEINE SULFATE

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2009-07-16

22402 / 1

Active Ingredient

CODEINE SULFATE

Application Number

22402

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2009-07-16

Regulatory Status

RX

2009
16 Jul
RX Application: 22402

Drug Name

CODEINE SULFATE

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2009-07-16

22402 / 2

Active Ingredient

CODEINE SULFATE

Application Number

22402

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2009-07-16

Regulatory Status

RX

2009
16 Jul
RX Application: 22402

Drug Name

CODEINE SULFATE

Product Number

3

Dosage Form

-

Strength

60MG

Approval Date

2009-07-16

22402 / 3

Active Ingredient

CODEINE SULFATE

Application Number

22402

Product Number

3

Dosage Form

-

Strength

60MG

Approval Date

2009-07-16

Regulatory Status

RX

2011
30 Jun
Discontinued Application: 202245

Drug Name

CODEINE SULFATE

Product Number

1

Dosage Form

-

Strength

30MG/5ML

Approval Date

2011-06-30

202245 / 1

Active Ingredient

CODEINE SULFATE

Application Number

202245

Product Number

1

Dosage Form

-

Strength

30MG/5ML

Approval Date

2011-06-30

Regulatory Status

Discontinued

2023
17 Oct
RX Application: 215320

Drug Name

COMBOGESIC IV

Product Number

1

Dosage Form

-

Strength

1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML)

Approval Date

2023-10-17

215320 / 1

Active Ingredient

ACETAMINOPHEN; IBUPROFEN SODIUM

Application Number

215320

Product Number

1

Dosage Form

-

Strength

1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML)

Approval Date

2023-10-17

Regulatory Status

RX

1997
16 May
Discontinued Application: 74220

Drug Name

CORMAX

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

1997-05-16

74220 / 1

Active Ingredient

CLOBETASOL PROPIONATE

Application Number

74220

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

1997-05-16

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 80776

Drug Name

CORTISONE ACETATE

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

80776 / 2

Active Ingredient

CORTISONE ACETATE

Application Number

80776

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2002
30 Apr
Discontinued Application: 75333

Drug Name

CROMOLYN SODIUM

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2002-04-30

75333 / 1

Active Ingredient

CROMOLYN SODIUM

Application Number

75333

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2002-04-30

Regulatory Status

Discontinued

2013
16 Sep
RX Application: 203856

Drug Name

CYCLOPHOSPHAMIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2013-09-16

203856 / 1

Active Ingredient

CYCLOPHOSPHAMIDE

Application Number

203856

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2013-09-16

Regulatory Status

RX

2013
16 Sep
RX Application: 203856

Drug Name

CYCLOPHOSPHAMIDE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2013-09-16

203856 / 2

Active Ingredient

CYCLOPHOSPHAMIDE

Application Number

203856

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2013-09-16

Regulatory Status

RX

2023
18 Dec
RX Application: 216958

Drug Name

CYCLOPHOSPHAMIDE

Product Number

1

Dosage Form

-

Strength

500MG/VIAL

Approval Date

2023-12-18

216958 / 1

Active Ingredient

CYCLOPHOSPHAMIDE

Application Number

216958

Product Number

1

Dosage Form

-

Strength

500MG/VIAL

Approval Date

2023-12-18

Regulatory Status

RX

2023
18 Dec
RX Application: 216958

Drug Name

CYCLOPHOSPHAMIDE

Product Number

2

Dosage Form

-

Strength

1GM/VIAL

Approval Date

2023-12-18

216958 / 2

Active Ingredient

CYCLOPHOSPHAMIDE

Application Number

216958

Product Number

2

Dosage Form

-

Strength

1GM/VIAL

Approval Date

2023-12-18

Regulatory Status

RX

2023
18 Dec
RX Application: 216958

Drug Name

CYCLOPHOSPHAMIDE

Product Number

3

Dosage Form

-

Strength

2GM/VIAL

Approval Date

2023-12-18

216958 / 3

Active Ingredient

CYCLOPHOSPHAMIDE

Application Number

216958

Product Number

3

Dosage Form

-

Strength

2GM/VIAL

Approval Date

2023-12-18

Regulatory Status

RX

1999
29 Oct
RX Application: 65004

Drug Name

CYCLOSPORINE

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

1999-10-29

65004 / 1

Active Ingredient

CYCLOSPORINE

Application Number

65004

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

1999-10-29

Regulatory Status

RX

1989
02 Aug
RX Application: 71471

Drug Name

CYTARABINE

Product Number

1

Dosage Form

-

Strength

100MG/VIAL

Approval Date

1989-08-02

71471 / 1

Active Ingredient

CYTARABINE

Application Number

71471

Product Number

1

Dosage Form

-

Strength

100MG/VIAL

Approval Date

1989-08-02

Regulatory Status

RX

1989
02 Aug
RX Application: 71472

Drug Name

CYTARABINE

Product Number

1

Dosage Form

-

Strength

500MG/VIAL

Approval Date

1989-08-02

71472 / 1

Active Ingredient

CYTARABINE

Application Number

71472

Product Number

1

Dosage Form

-

Strength

500MG/VIAL

Approval Date

1989-08-02

Regulatory Status

RX

2001
15 Jun
RX Application: 75812

Drug Name

DACARBAZINE

Product Number

1

Dosage Form

-

Strength

200MG/VIAL

Approval Date

2001-06-15

75812 / 1

Active Ingredient

DACARBAZINE

Application Number

75812

Product Number

1

Dosage Form

-

Strength

200MG/VIAL

Approval Date

2001-06-15

Regulatory Status

RX

2002
31 Oct
RX Application: 75812

Drug Name

DACARBAZINE

Product Number

2

Dosage Form

-

Strength

500MG/VIAL

Approval Date

2002-10-31

75812 / 2

Active Ingredient

DACARBAZINE

Application Number

75812

Product Number

2

Dosage Form

-

Strength

500MG/VIAL

Approval Date

2002-10-31

Regulatory Status

RX

2010
16 Mar
Discontinued Application: 90304

Drug Name

DACTINOMYCIN

Product Number

1

Dosage Form

-

Strength

0.5MG/VIAL

Approval Date

2010-03-16

90304 / 1

Active Ingredient

DACTINOMYCIN

Application Number

90304

Product Number

1

Dosage Form

-

Strength

0.5MG/VIAL

Approval Date

2010-03-16

Regulatory Status

Discontinued

2018
24 Oct
Discontinued Application: 206646

Drug Name

DALFAMPRIDINE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2018-10-24

206646 / 1

Active Ingredient

DALFAMPRIDINE

Application Number

206646

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2018-10-24

Regulatory Status

Discontinued

2017
19 Jun
RX Application: 204762

Drug Name

DANTROLENE SODIUM

Product Number

1

Dosage Form

-

Strength

20MG/VIAL

Approval Date

2017-06-19

204762 / 1

Active Ingredient

DANTROLENE SODIUM

Application Number

204762

Product Number

1

Dosage Form

-

Strength

20MG/VIAL

Approval Date

2017-06-19

Regulatory Status

RX

2017
20 Oct
RX Application: 209949

Drug Name

DAPTOMYCIN

Product Number

1

Dosage Form

-

Strength

350MG/VIAL

Approval Date

2017-10-20

209949 / 1

Active Ingredient

DAPTOMYCIN

Application Number

209949

Product Number

1

Dosage Form

-

Strength

350MG/VIAL

Approval Date

2017-10-20

Regulatory Status

RX

2023
30 Jan
RX Application: 217415

Drug Name

DAPTOMYCIN

Product Number

1

Dosage Form

-

Strength

350MG/VIAL

Approval Date

2023-01-30

217415 / 1

Active Ingredient

DAPTOMYCIN

Application Number

217415

Product Number

1

Dosage Form

-

Strength

350MG/VIAL

Approval Date

2023-01-30

Regulatory Status

RX

2023
30 Jan
RX Application: 217415

Drug Name

DAPTOMYCIN

Product Number

2

Dosage Form

-

Strength

500MG/VIAL

Approval Date

2023-01-30

217415 / 2

Active Ingredient

DAPTOMYCIN

Application Number

217415

Product Number

2

Dosage Form

-

Strength

500MG/VIAL

Approval Date

2023-01-30

Regulatory Status

RX

1998
30 Jan
RX Application: 50731

Drug Name

DAUNORUBICIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

1998-01-30

50731 / 1

Active Ingredient

DAUNORUBICIN HYDROCHLORIDE

Application Number

50731

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

1998-01-30

Regulatory Status

RX

2021
29 Mar
RX Application: 213239

Drug Name

DEFERIPRONE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2021-03-29

213239 / 1

Active Ingredient

DEFERIPRONE

Application Number

213239

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2021-03-29

Regulatory Status

RX

2022
08 Feb
RX Application: 213239

Drug Name

DEFERIPRONE

Product Number

2

Dosage Form

-

Strength

1GM

Approval Date

2022-02-08

213239 / 2

Active Ingredient

DEFERIPRONE

Application Number

213239

Product Number

2

Dosage Form

-

Strength

1GM

Approval Date

2022-02-08

Regulatory Status

RX

2007
30 May
Discontinued Application: 78086

Drug Name

DEFEROXAMINE MESYLATE

Product Number

1

Dosage Form

-

Strength

500MG/VIAL

Approval Date

2007-05-30

78086 / 1

Active Ingredient

DEFEROXAMINE MESYLATE

Application Number

78086

Product Number

1

Dosage Form

-

Strength

500MG/VIAL

Approval Date

2007-05-30

Regulatory Status

Discontinued

2007
30 May
Discontinued Application: 78086

Drug Name

DEFEROXAMINE MESYLATE

Product Number

2

Dosage Form

-

Strength

2GM/VIAL

Approval Date

2007-05-30

78086 / 2

Active Ingredient

DEFEROXAMINE MESYLATE

Application Number

78086

Product Number

2

Dosage Form

-

Strength

2GM/VIAL

Approval Date

2007-05-30

Regulatory Status

Discontinued

2017
27 Mar
Discontinued Application: 208836

Drug Name

DESONIDE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2017-03-27

208836 / 1

Active Ingredient

DESONIDE

Application Number

208836

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2017-03-27

Regulatory Status

Discontinued

2016
16 Feb
RX Application: 204083

Drug Name

DESVENLAFAXINE SUCCINATE

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2016-02-16

204083 / 1

Active Ingredient

DESVENLAFAXINE SUCCINATE

Application Number

204083

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2016-02-16

Regulatory Status

RX

2016
16 Feb
RX Application: 204083

Drug Name

DESVENLAFAXINE SUCCINATE

Product Number

2

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2016-02-16

204083 / 2

Active Ingredient

DESVENLAFAXINE SUCCINATE

Application Number

204083

Product Number

2

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2016-02-16

Regulatory Status

RX

2016
16 Feb
RX Application: 204083

Drug Name

DESVENLAFAXINE SUCCINATE

Product Number

3

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2016-02-16

204083 / 3

Active Ingredient

DESVENLAFAXINE SUCCINATE

Application Number

204083

Product Number

3

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2016-02-16

Regulatory Status

RX

1982
01 Jan
RX Application: 84612

Drug Name

DEXAMETHASONE

Product Number

1

Dosage Form

-

Strength

4MG

Approval Date

1982-01-01

84612 / 1

Active Ingredient

DEXAMETHASONE

Application Number

84612

Product Number

1

Dosage Form

-

Strength

4MG

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 84612

Drug Name

DEXAMETHASONE

Product Number

2

Dosage Form

-

Strength

0.5MG

Approval Date

1982-01-01

84612 / 2

Active Ingredient

DEXAMETHASONE

Application Number

84612

Product Number

2

Dosage Form

-

Strength

0.5MG

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 84612

Drug Name

DEXAMETHASONE

Product Number

3

Dosage Form

-

Strength

0.75MG

Approval Date

1982-01-01

84612 / 3

Active Ingredient

DEXAMETHASONE

Application Number

84612

Product Number

3

Dosage Form

-

Strength

0.75MG

Approval Date

1982-01-01

Regulatory Status

RX

1983
15 Sep
RX Application: 84612

Drug Name

DEXAMETHASONE

Product Number

4

Dosage Form

-

Strength

1MG

Approval Date

1983-09-15

84612 / 4

Active Ingredient

DEXAMETHASONE

Application Number

84612

Product Number

4

Dosage Form

-

Strength

1MG

Approval Date

1983-09-15

Regulatory Status

RX

1982
01 Jan
RX Application: 84612

Drug Name

DEXAMETHASONE

Product Number

5

Dosage Form

-

Strength

1.5MG

Approval Date

1982-01-01

84612 / 5

Active Ingredient

DEXAMETHASONE

Application Number

84612

Product Number

5

Dosage Form

-

Strength

1.5MG

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 84612

Drug Name

DEXAMETHASONE

Product Number

6

Dosage Form

-

Strength

2MG

Approval Date

1982-01-01

84612 / 6

Active Ingredient

DEXAMETHASONE

Application Number

84612

Product Number

6

Dosage Form

-

Strength

2MG

Approval Date

1982-01-01

Regulatory Status

RX

1983
15 Sep
RX Application: 84612

Drug Name

DEXAMETHASONE

Product Number

7

Dosage Form

-

Strength

6MG

Approval Date

1983-09-15

84612 / 7

Active Ingredient

DEXAMETHASONE

Application Number

84612

Product Number

7

Dosage Form

-

Strength

6MG

Approval Date

1983-09-15

Regulatory Status

RX

1983
01 Sep
RX Application: 88248

Drug Name

DEXAMETHASONE

Product Number

1

Dosage Form

-

Strength

0.5MG/5ML

Approval Date

1983-09-01

88248 / 1

Active Ingredient

DEXAMETHASONE

Application Number

88248

Product Number

1

Dosage Form

-

Strength

0.5MG/5ML

Approval Date

1983-09-01

Regulatory Status

RX

-
Unclassified Application: 88316

Drug Name

DEXAMETHASONE

Product Number

1

Dosage Form

-

Strength

6MG

Approval Date

-

88316 / 1

Active Ingredient

DEXAMETHASONE

Application Number

88316

Product Number

1

Dosage Form

-

Strength

6MG

Approval Date

-

Regulatory Status

Unclassified

1983
01 Sep
RX Application: 88252

Drug Name

DEXAMETHASONE INTENSOL

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

1983-09-01

88252 / 1

Active Ingredient

DEXAMETHASONE

Application Number

88252

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

1983-09-01

Regulatory Status

RX

1982
01 Jan
RX Application: 84282

Drug Name

DEXAMETHASONE SODIUM PHOSPHATE

Product Number

1

Dosage Form

-

Strength

EQ 4MG PHOSPHATE/ML

Approval Date

1982-01-01

84282 / 1

Active Ingredient

DEXAMETHASONE SODIUM PHOSPHATE

Application Number

84282

Product Number

1

Dosage Form

-

Strength

EQ 4MG PHOSPHATE/ML

Approval Date

1982-01-01

Regulatory Status

RX

1982
07 Sep
RX Application: 87702

Drug Name

DEXAMETHASONE SODIUM PHOSPHATE

Product Number

1

Dosage Form

-

Strength

EQ 10MG PHOSPHATE/ML

Approval Date

1982-09-07

87702 / 1

Active Ingredient

DEXAMETHASONE SODIUM PHOSPHATE

Application Number

87702

Product Number

1

Dosage Form

-

Strength

EQ 10MG PHOSPHATE/ML

Approval Date

1982-09-07

Regulatory Status

RX

2023
01 Aug
Discontinued Application: 211451

Drug Name

DEXAMETHASONE SODIUM PHOSPHATE

Product Number

1

Dosage Form

-

Strength

EQ 4MG PHOSPHATE/ML

Approval Date

2023-08-01

211451 / 1

Active Ingredient

DEXAMETHASONE SODIUM PHOSPHATE

Application Number

211451

Product Number

1

Dosage Form

-

Strength

EQ 4MG PHOSPHATE/ML

Approval Date

2023-08-01

Regulatory Status

Discontinued

2017
26 Apr
RX Application: 205046

Drug Name

DEXMEDETOMIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)

Approval Date

2017-04-26

205046 / 1

Active Ingredient

DEXMEDETOMIDINE HYDROCHLORIDE

Application Number

205046

Product Number

1

Dosage Form

-

Strength

EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)

Approval Date

2017-04-26

Regulatory Status

RX

2020
30 Jan
RX Application: 206407

Drug Name

DEXMEDETOMIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)

Approval Date

2020-01-30

206407 / 1

Active Ingredient

DEXMEDETOMIDINE HYDROCHLORIDE

Application Number

206407

Product Number

1

Dosage Form

-

Strength

EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)

Approval Date

2020-01-30

Regulatory Status

RX

2020
30 Jan
RX Application: 206407

Drug Name

DEXMEDETOMIDINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)

Approval Date

2020-01-30

206407 / 2

Active Ingredient

DEXMEDETOMIDINE HYDROCHLORIDE

Application Number

206407

Product Number

2

Dosage Form

-

Strength

EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)

Approval Date

2020-01-30

Regulatory Status

RX

2025
30 May
RX Application: 206407

Drug Name

DEXMEDETOMIDINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 1MG BASE/250ML (EQ 4MCG BASE/ML)

Approval Date

2025-05-30

206407 / 3

Active Ingredient

DEXMEDETOMIDINE HYDROCHLORIDE

Application Number

206407

Product Number

3

Dosage Form

-

Strength

EQ 1MG BASE/250ML (EQ 4MCG BASE/ML)

Approval Date

2025-05-30

Regulatory Status

RX

2004
28 Sep
RX Application: 76068

Drug Name

DEXRAZOXANE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE/VIAL

Approval Date

2004-09-28

76068 / 1

Active Ingredient

DEXRAZOXANE HYDROCHLORIDE

Application Number

76068

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE/VIAL

Approval Date

2004-09-28

Regulatory Status

RX

2004
28 Sep
RX Application: 76068

Drug Name

DEXRAZOXANE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2004-09-28

76068 / 2

Active Ingredient

DEXRAZOXANE HYDROCHLORIDE

Application Number

76068

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2004-09-28

Regulatory Status

RX

1985
16 Dec
RX Application: 70311

Drug Name

DIAZEPAM

Product Number

1

Dosage Form

-

Strength

50MG/10ML (5MG/ML)

Approval Date

1985-12-16

70311 / 1

Active Ingredient

DIAZEPAM

Application Number

70311

Product Number

1

Dosage Form

-

Strength

50MG/10ML (5MG/ML)

Approval Date

1985-12-16

Regulatory Status

RX

1985
16 Dec
Discontinued Application: 70311

Drug Name

DIAZEPAM

Product Number

2

Dosage Form

-

Strength

5MG/ML (5MG/ML)

Approval Date

1985-12-16

70311 / 2

Active Ingredient

DIAZEPAM

Application Number

70311

Product Number

2

Dosage Form

-

Strength

5MG/ML (5MG/ML)

Approval Date

1985-12-16

Regulatory Status

Discontinued

1985
16 Dec
Discontinued Application: 70311

Drug Name

DIAZEPAM

Product Number

3

Dosage Form

-

Strength

10MG/2ML (5MG/ML)

Approval Date

1985-12-16

70311 / 3

Active Ingredient

DIAZEPAM

Application Number

70311

Product Number

3

Dosage Form

-

Strength

10MG/2ML (5MG/ML)

Approval Date

1985-12-16

Regulatory Status

Discontinued

1985
16 Dec
Discontinued Application: 70312

Drug Name

DIAZEPAM

Product Number

1

Dosage Form

-

Strength

5MG/ML

Approval Date

1985-12-16

70312 / 1

Active Ingredient

DIAZEPAM

Application Number

70312

Product Number

1

Dosage Form

-

Strength

5MG/ML

Approval Date

1985-12-16

Regulatory Status

Discontinued

1985
16 Dec
RX Application: 70313

Drug Name

DIAZEPAM

Product Number

1

Dosage Form

-

Strength

10MG/2ML (5MG/ML)

Approval Date

1985-12-16

70313 / 1

Active Ingredient

DIAZEPAM

Application Number

70313

Product Number

1

Dosage Form

-

Strength

10MG/2ML (5MG/ML)

Approval Date

1985-12-16

Regulatory Status

RX

1987
03 Apr
RX Application: 70928

Drug Name

DIAZEPAM

Product Number

1

Dosage Form

-

Strength

5MG/5ML

Approval Date

1987-04-03

70928 / 1

Active Ingredient

DIAZEPAM

Application Number

70928

Product Number

1

Dosage Form

-

Strength

5MG/5ML

Approval Date

1987-04-03

Regulatory Status

RX

1987
17 Jul
Discontinued Application: 71308

Drug Name

DIAZEPAM

Product Number

1

Dosage Form

-

Strength

5MG/ML

Approval Date

1987-07-17

71308 / 1

Active Ingredient

DIAZEPAM

Application Number

71308

Product Number

1

Dosage Form

-

Strength

5MG/ML

Approval Date

1987-07-17

Regulatory Status

Discontinued

1987
17 Jul
Discontinued Application: 71309

Drug Name

DIAZEPAM

Product Number

1

Dosage Form

-

Strength

5MG/ML

Approval Date

1987-07-17

71309 / 1

Active Ingredient

DIAZEPAM

Application Number

71309

Product Number

1

Dosage Form

-

Strength

5MG/ML

Approval Date

1987-07-17

Regulatory Status

Discontinued

1987
17 Jul
Discontinued Application: 71310

Drug Name

DIAZEPAM

Product Number

1

Dosage Form

-

Strength

5MG/ML

Approval Date

1987-07-17

71310 / 1

Active Ingredient

DIAZEPAM

Application Number

71310

Product Number

1

Dosage Form

-

Strength

5MG/ML

Approval Date

1987-07-17

Regulatory Status

Discontinued

1987
03 Apr
RX Application: 71415

Drug Name

DIAZEPAM INTENSOL

Product Number

1

Dosage Form

-

Strength

5MG/ML

Approval Date

1987-04-03

71415 / 1

Active Ingredient

DIAZEPAM

Application Number

71415

Product Number

1

Dosage Form

-

Strength

5MG/ML

Approval Date

1987-04-03

Regulatory Status

RX

2018
21 Nov
Discontinued Application: 209484

Drug Name

DICLOFENAC SODIUM

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

2018-11-21

209484 / 1

Active Ingredient

DICLOFENAC SODIUM

Application Number

209484

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

2018-11-21

Regulatory Status

Discontinued

1996
01 Oct
RX Application: 40161

Drug Name

DICYCLOMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

1996-10-01

40161 / 1

Active Ingredient

DICYCLOMINE HYDROCHLORIDE

Application Number

40161

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

1996-10-01

Regulatory Status

RX

2019
11 Feb
Discontinued Application: 210788

Drug Name

DICYCLOMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2019-02-11

210788 / 1

Active Ingredient

DICYCLOMINE HYDROCHLORIDE

Application Number

210788

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2019-02-11

Regulatory Status

Discontinued

2020
22 May
RX Application: 212286

Drug Name

DICYCLOMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG/5ML

Approval Date

2020-05-22

212286 / 1

Active Ingredient

DICYCLOMINE HYDROCHLORIDE

Application Number

212286

Product Number

1

Dosage Form

-

Strength

10MG/5ML

Approval Date

2020-05-22

Regulatory Status

RX

2003
30 Jun
RX Application: 40465

Drug Name

DICYCLOMINE HYDROCHLORIDE (PRESERVATIVE FREE)

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2003-06-30

40465 / 1

Active Ingredient

DICYCLOMINE HYDROCHLORIDE

Application Number

40465

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2003-06-30

Regulatory Status

RX

2004
26 Aug
RX Application: 21648

Drug Name

DIGOXIN

Product Number

1

Dosage Form

-

Strength

0.05MG/ML

Approval Date

2004-08-26

21648 / 1

Active Ingredient

DIGOXIN

Application Number

21648

Product Number

1

Dosage Form

-

Strength

0.05MG/ML

Approval Date

2004-08-26

Regulatory Status

RX

2007
30 Oct
RX Application: 77002

Drug Name

DIGOXIN

Product Number

1

Dosage Form

-

Strength

0.25MG

Approval Date

2007-10-30

77002 / 1

Active Ingredient

DIGOXIN

Application Number

77002

Product Number

1

Dosage Form

-

Strength

0.25MG

Approval Date

2007-10-30

Regulatory Status

RX

2007
30 Oct
RX Application: 77002

Drug Name

DIGOXIN

Product Number

2

Dosage Form

-

Strength

0.125MG

Approval Date

2007-10-30

77002 / 2

Active Ingredient

DIGOXIN

Application Number

77002

Product Number

2

Dosage Form

-

Strength

0.125MG

Approval Date

2007-10-30

Regulatory Status

RX

1982
01 Jan
RX Application: 83391

Drug Name

DIGOXIN

Product Number

1

Dosage Form

-

Strength

0.25MG/ML

Approval Date

1982-01-01

83391 / 1

Active Ingredient

DIGOXIN

Application Number

83391

Product Number

1

Dosage Form

-

Strength

0.25MG/ML

Approval Date

1982-01-01

Regulatory Status

RX

2003
09 Jun
RX Application: 40453

Drug Name

DIHYDROERGOTAMINE MESYLATE

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2003-06-09

40453 / 1

Active Ingredient

DIHYDROERGOTAMINE MESYLATE

Application Number

40453

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2003-06-09

Regulatory Status

RX

2017
15 Sep
RX Application: 206621

Drug Name

DIHYDROERGOTAMINE MESYLATE

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2017-09-15

206621 / 1

Active Ingredient

DIHYDROERGOTAMINE MESYLATE

Application Number

206621

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2017-09-15

Regulatory Status

RX

2020
28 Feb
RX Application: 211393

Drug Name

DIHYDROERGOTAMINE MESYLATE

Product Number

1

Dosage Form

-

Strength

0.5MG/SPRAY

Approval Date

2020-02-28

211393 / 1

Active Ingredient

DIHYDROERGOTAMINE MESYLATE

Application Number

211393

Product Number

1

Dosage Form

-

Strength

0.5MG/SPRAY

Approval Date

2020-02-28

Regulatory Status

RX

2008
17 Dec
RX Application: 78538

Drug Name

DILTIAZEM HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG/ML

Approval Date

2008-12-17

78538 / 1

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

78538

Product Number

1

Dosage Form

-

Strength

5MG/ML

Approval Date

2008-12-17

Regulatory Status

RX

2012
09 Aug
Discontinued Application: 202651

Drug Name

DILTIAZEM HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG/ML

Approval Date

2012-08-09

202651 / 1

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

202651

Product Number

1

Dosage Form

-

Strength

5MG/ML

Approval Date

2012-08-09

Regulatory Status

Discontinued

-
Unclassified Application: 202651

Drug Name

DILTIAZEM HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

50MG/10ML

Approval Date

-

202651 / 2

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

202651

Product Number

2

Dosage Form

-

Strength

50MG/10ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 202651

Drug Name

DILTIAZEM HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

125MG/25ML

Approval Date

-

202651 / 3

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

202651

Product Number

3

Dosage Form

-

Strength

125MG/25ML

Approval Date

-

Regulatory Status

Unclassified

1982
01 Jan
Discontinued Application: 83183

Drug Name

DIPHENHYDRAMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

1982-01-01

83183 / 1

Active Ingredient

DIPHENHYDRAMINE HYDROCHLORIDE

Application Number

83183

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83567

Drug Name

DIPHENHYDRAMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

83567 / 1

Active Ingredient

DIPHENHYDRAMINE HYDROCHLORIDE

Application Number

83567

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
03 May
RX Application: 87708

Drug Name

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE

Product Number

1

Dosage Form

-

Strength

0.025MG/5ML;2.5MG/5ML

Approval Date

1982-05-03

87708 / 1

Active Ingredient

ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE

Application Number

87708

Product Number

1

Dosage Form

-

Strength

0.025MG/5ML;2.5MG/5ML

Approval Date

1982-05-03

Regulatory Status

RX

1982
15 Mar
Discontinued Application: 87765

Drug Name

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE

Product Number

1

Dosage Form

-

Strength

0.025MG;2.5MG

Approval Date

1982-03-15

87765 / 1

Active Ingredient

ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE

Application Number

87765

Product Number

1

Dosage Form

-

Strength

0.025MG;2.5MG

Approval Date

1982-03-15

Regulatory Status

Discontinued

1996
18 Oct
RX Application: 74521

Drug Name

DIPYRIDAMOLE

Product Number

1

Dosage Form

-

Strength

5MG/ML

Approval Date

1996-10-18

74521 / 1

Active Ingredient

DIPYRIDAMOLE

Application Number

74521

Product Number

1

Dosage Form

-

Strength

5MG/ML

Approval Date

1996-10-18

Regulatory Status

RX

2014
05 Feb
Discontinued Application: 202652

Drug Name

DISULFIRAM

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2014-02-05

202652 / 1

Active Ingredient

DISULFIRAM

Application Number

202652

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2014-02-05

Regulatory Status

Discontinued

2014
05 Feb
Discontinued Application: 202652

Drug Name

DISULFIRAM

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2014-02-05

202652 / 2

Active Ingredient

DISULFIRAM

Application Number

202652

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2014-02-05

Regulatory Status

Discontinued

1994
31 Oct
RX Application: 74277

Drug Name

DOBUTAMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 12.5MG BASE/ML

Approval Date

1994-10-31

74277 / 1

Active Ingredient

DOBUTAMINE HYDROCHLORIDE

Application Number

74277

Product Number

1

Dosage Form

-

Strength

EQ 12.5MG BASE/ML

Approval Date

1994-10-31

Regulatory Status

RX

2021
14 Jan
RX Application: 204490

Drug Name

DOCETAXEL

Product Number

1

Dosage Form

-

Strength

20MG/ML (20MG/ML)

Approval Date

2021-01-14

204490 / 1

Active Ingredient

DOCETAXEL

Application Number

204490

Product Number

1

Dosage Form

-

Strength

20MG/ML (20MG/ML)

Approval Date

2021-01-14

Regulatory Status

RX

2021
14 Jan
RX Application: 204490

Drug Name

DOCETAXEL

Product Number

2

Dosage Form

-

Strength

80MG/4ML (20MG/ML)

Approval Date

2021-01-14

204490 / 2

Active Ingredient

DOCETAXEL

Application Number

204490

Product Number

2

Dosage Form

-

Strength

80MG/4ML (20MG/ML)

Approval Date

2021-01-14

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 6134

Drug Name

DOLOPHINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Active Ingredient

METHADONE HYDROCHLORIDE

Application Number

6134

Product Number

2

Dosage Form

-

Strength

5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 6134

Drug Name

DOLOPHINE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

10MG/30ML

Approval Date

1982-01-01

Active Ingredient

METHADONE HYDROCHLORIDE

Application Number

6134

Product Number

4

Dosage Form

-

Strength

10MG/30ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 6134

Drug Name

DOLOPHINE HYDROCHLORIDE

Product Number

10

Dosage Form

-

Strength

10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

6134 / 10

Active Ingredient

METHADONE HYDROCHLORIDE

Application Number

6134

Product Number

10

Dosage Form

-

Strength

10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

2011
31 May
Discontinued Application: 90247

Drug Name

DONEPEZIL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2011-05-31

90247 / 1

Active Ingredient

DONEPEZIL HYDROCHLORIDE

Application Number

90247

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2011-05-31

Regulatory Status

Discontinued

2011
31 May
Discontinued Application: 90247

Drug Name

DONEPEZIL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2011-05-31

90247 / 2

Active Ingredient

DONEPEZIL HYDROCHLORIDE

Application Number

90247

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2011-05-31

Regulatory Status

Discontinued

2018
11 Apr
RX Application: 207707

Drug Name

DOPAMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

40MG/ML

Approval Date

2018-04-11

207707 / 1

Active Ingredient

DOPAMINE HYDROCHLORIDE

Application Number

207707

Product Number

1

Dosage Form

-

Strength

40MG/ML

Approval Date

2018-04-11

Regulatory Status

RX

2018
11 Apr
RX Application: 207707

Drug Name

DOPAMINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

80MG/ML

Approval Date

2018-04-11

207707 / 2

Active Ingredient

DOPAMINE HYDROCHLORIDE

Application Number

207707

Product Number

2

Dosage Form

-

Strength

80MG/ML

Approval Date

2018-04-11

Regulatory Status

RX

1982
01 Jan
RX Application: 14879

Drug Name

DOPRAM

Product Number

1

Dosage Form

-

Strength

20MG/ML

Approval Date

1982-01-01

14879 / 1

Active Ingredient

DOXAPRAM HYDROCHLORIDE

Application Number

14879

Product Number

1

Dosage Form

-

Strength

20MG/ML

Approval Date

1982-01-01

Regulatory Status

RX

2008
28 Oct
Discontinued Application: 77846

Drug Name

DORZOLAMIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 2% BASE

Approval Date

2008-10-28

77846 / 1

Active Ingredient

DORZOLAMIDE HYDROCHLORIDE

Application Number

77846

Product Number

1

Dosage Form

-

Strength

EQ 2% BASE

Approval Date

2008-10-28

Regulatory Status

Discontinued

2008
28 Oct
Discontinued Application: 77847

Drug Name

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE

Product Number

1

Dosage Form

-

Strength

EQ 2% BASE;EQ 0.5% BASE

Approval Date

2008-10-28

77847 / 1

Active Ingredient

DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE

Application Number

77847

Product Number

1

Dosage Form

-

Strength

EQ 2% BASE;EQ 0.5% BASE

Approval Date

2008-10-28

Regulatory Status

Discontinued

2013
30 Aug
Discontinued Application: 91101

Drug Name

DOXERCALCIFEROL

Product Number

1

Dosage Form

-

Strength

4MCG/2ML (2MCG/ML)

Approval Date

2013-08-30

91101 / 1

Active Ingredient

DOXERCALCIFEROL

Application Number

91101

Product Number

1

Dosage Form

-

Strength

4MCG/2ML (2MCG/ML)

Approval Date

2013-08-30

Regulatory Status

Discontinued

2011
23 Sep
Discontinued Application: 91433

Drug Name

DOXERCALCIFEROL

Product Number

1

Dosage Form

-

Strength

0.5MCG

Approval Date

2011-09-23

91433 / 1

Active Ingredient

DOXERCALCIFEROL

Application Number

91433

Product Number

1

Dosage Form

-

Strength

0.5MCG

Approval Date

2011-09-23

Regulatory Status

Discontinued

2014
14 Jan
Discontinued Application: 91433

Drug Name

DOXERCALCIFEROL

Product Number

2

Dosage Form

-

Strength

1MCG

Approval Date

2014-01-14

91433 / 2

Active Ingredient

DOXERCALCIFEROL

Application Number

91433

Product Number

2

Dosage Form

-

Strength

1MCG

Approval Date

2014-01-14

Regulatory Status

Discontinued

2014
14 Jan
Discontinued Application: 91433

Drug Name

DOXERCALCIFEROL

Product Number

3

Dosage Form

-

Strength

2.5MCG

Approval Date

2014-01-14

91433 / 3

Active Ingredient

DOXERCALCIFEROL

Application Number

91433

Product Number

3

Dosage Form

-

Strength

2.5MCG

Approval Date

2014-01-14

Regulatory Status

Discontinued

1989
17 Mar
RX Application: 62921

Drug Name

DOXORUBICIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG/VIAL

Approval Date

1989-03-17

62921 / 1

Active Ingredient

DOXORUBICIN HYDROCHLORIDE

Application Number

62921

Product Number

1

Dosage Form

-

Strength

10MG/VIAL

Approval Date

1989-03-17

Regulatory Status

RX

1989
17 Mar
RX Application: 62921

Drug Name

DOXORUBICIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

20MG/VIAL

Approval Date

1989-03-17

62921 / 2

Active Ingredient

DOXORUBICIN HYDROCHLORIDE

Application Number

62921

Product Number

2

Dosage Form

-

Strength

20MG/VIAL

Approval Date

1989-03-17

Regulatory Status

RX

1989
17 Mar
RX Application: 62921

Drug Name

DOXORUBICIN HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

50MG/VIAL

Approval Date

1989-03-17

62921 / 3

Active Ingredient

DOXORUBICIN HYDROCHLORIDE

Application Number

62921

Product Number

3

Dosage Form

-

Strength

50MG/VIAL

Approval Date

1989-03-17

Regulatory Status

RX

1989
17 Mar
RX Application: 62975

Drug Name

DOXORUBICIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

2MG/ML

Approval Date

1989-03-17

62975 / 1

Active Ingredient

DOXORUBICIN HYDROCHLORIDE

Application Number

62975

Product Number

1

Dosage Form

-

Strength

2MG/ML

Approval Date

1989-03-17

Regulatory Status

RX

1994
13 Sep
RX Application: 64097

Drug Name

DOXORUBICIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

200MG/100ML

Approval Date

1994-09-13

64097 / 1

Active Ingredient

DOXORUBICIN HYDROCHLORIDE

Application Number

64097

Product Number

1

Dosage Form

-

Strength

200MG/100ML

Approval Date

1994-09-13

Regulatory Status

RX

1983
27 Oct
Discontinued Application: 62450

Drug Name

DOXYCYCLINE

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE/VIAL

Approval Date

1983-10-27

62450 / 1

Active Ingredient

DOXYCYCLINE HYCLATE

Application Number

62450

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE/VIAL

Approval Date

1983-10-27

Regulatory Status

Discontinued

1983
27 Oct
Discontinued Application: 62450

Drug Name

DOXYCYCLINE

Product Number

2

Dosage Form

-

Strength

EQ 200MG BASE/VIAL

Approval Date

1983-10-27

62450 / 2

Active Ingredient

DOXYCYCLINE HYCLATE

Application Number

62450

Product Number

2

Dosage Form

-

Strength

EQ 200MG BASE/VIAL

Approval Date

1983-10-27

Regulatory Status

Discontinued

1988
09 Mar
Discontinued Application: 62569

Drug Name

DOXYCYCLINE

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE/VIAL

Approval Date

1988-03-09

62569 / 1

Active Ingredient

DOXYCYCLINE HYCLATE

Application Number

62569

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE/VIAL

Approval Date

1988-03-09

Regulatory Status

Discontinued

1988
09 Mar
Discontinued Application: 62569

Drug Name

DOXYCYCLINE

Product Number

2

Dosage Form

-

Strength

EQ 200MG BASE/VIAL

Approval Date

1988-03-09

62569 / 2

Active Ingredient

DOXYCYCLINE HYCLATE

Application Number

62569

Product Number

2

Dosage Form

-

Strength

EQ 200MG BASE/VIAL

Approval Date

1988-03-09

Regulatory Status

Discontinued

1984
07 May
RX Application: 62396

Drug Name

DOXYCYCLINE HYCLATE

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

1984-05-07

62396 / 1

Active Ingredient

DOXYCYCLINE HYCLATE

Application Number

62396

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

1984-05-07

Regulatory Status

RX

1984
07 Nov
RX Application: 62396

Drug Name

DOXYCYCLINE HYCLATE

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

1984-11-07

62396 / 2

Active Ingredient

DOXYCYCLINE HYCLATE

Application Number

62396

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

1984-11-07

Regulatory Status

RX

2003
02 Jul
RX Application: 65095

Drug Name

DOXYCYCLINE HYCLATE

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2003-07-02

65095 / 1

Active Ingredient

DOXYCYCLINE HYCLATE

Application Number

65095

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2003-07-02

Regulatory Status

RX

2005
13 May
Discontinued Application: 65103

Drug Name

DOXYCYCLINE HYCLATE

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2005-05-13

65103 / 1

Active Ingredient

DOXYCYCLINE HYCLATE

Application Number

65103

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2005-05-13

Regulatory Status

Discontinued

2014
20 Jun
Discontinued Application: 79217

Drug Name

DRONABINOL

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2014-06-20

79217 / 1

Active Ingredient

DRONABINOL

Application Number

79217

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2014-06-20

Regulatory Status

Discontinued

2014
20 Jun
Discontinued Application: 79217

Drug Name

DRONABINOL

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2014-06-20

79217 / 2

Active Ingredient

DRONABINOL

Application Number

79217

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2014-06-20

Regulatory Status

Discontinued

2014
20 Jun
Discontinued Application: 79217

Drug Name

DRONABINOL

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2014-06-20

79217 / 3

Active Ingredient

DRONABINOL

Application Number

79217

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2014-06-20

Regulatory Status

Discontinued

2017
14 Dec
RX Application: 208197

Drug Name

DROPERIDOL

Product Number

1

Dosage Form

-

Strength

2.5MG/ML

Approval Date

2017-12-14

208197 / 1

Active Ingredient

DROPERIDOL

Application Number

208197

Product Number

1

Dosage Form

-

Strength

2.5MG/ML

Approval Date

2017-12-14

Regulatory Status

RX

2021
18 Feb
Discontinued Application: 212835

Drug Name

DROXIDOPA

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2021-02-18

212835 / 1

Active Ingredient

DROXIDOPA

Application Number

212835

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2021-02-18

Regulatory Status

Discontinued

2021
18 Feb
Discontinued Application: 212835

Drug Name

DROXIDOPA

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2021-02-18

212835 / 2

Active Ingredient

DROXIDOPA

Application Number

212835

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2021-02-18

Regulatory Status

Discontinued

2021
18 Feb
Discontinued Application: 212835

Drug Name

DROXIDOPA

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

2021-02-18

212835 / 3

Active Ingredient

DROXIDOPA

Application Number

212835

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

2021-02-18

Regulatory Status

Discontinued

1984
18 Sep
RX Application: 18565

Drug Name

DURAMORPH PF

Product Number

1

Dosage Form

-

Strength

0.5MG/ML

Approval Date

1984-09-18

18565 / 1

Active Ingredient

MORPHINE SULFATE

Application Number

18565

Product Number

1

Dosage Form

-

Strength

0.5MG/ML

Approval Date

1984-09-18

Regulatory Status

RX

1984
18 Sep
RX Application: 18565

Drug Name

DURAMORPH PF

Product Number

2

Dosage Form

-

Strength

1MG/ML

Approval Date

1984-09-18

18565 / 2

Active Ingredient

MORPHINE SULFATE

Application Number

18565

Product Number

2

Dosage Form

-

Strength

1MG/ML

Approval Date

1984-09-18

Regulatory Status

RX

2015
23 Nov
Discontinued Application: 202204

Drug Name

DUTASTERIDE

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2015-11-23

202204 / 1

Active Ingredient

DUTASTERIDE

Application Number

202204

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2015-11-23

Regulatory Status

Discontinued

2024
06 May
RX Application: 215508

Drug Name

EDARAVONE

Product Number

1

Dosage Form

-

Strength

30MG/100ML (0.3MG/ML)

Approval Date

2024-05-06

215508 / 1

Active Ingredient

EDARAVONE

Application Number

215508

Product Number

1

Dosage Form

-

Strength

30MG/100ML (0.3MG/ML)

Approval Date

2024-05-06

Regulatory Status

RX

-
Unclassified Application: 215508

Drug Name

EDARAVONE

Product Number

2

Dosage Form

-

Strength

60mg/100mL

Approval Date

-

215508 / 2

Active Ingredient

EDARAVONE

Application Number

215508

Product Number

2

Dosage Form

-

Strength

60mg/100mL

Approval Date

-

Regulatory Status

Unclassified

2026
08 Apr
RX Application: 220033

Drug Name

ELTROMBOPAG OLAMINE

Product Number

1

Dosage Form

-

Strength

EQ 12.5MG ACID

Approval Date

2026-04-08

220033 / 1

Active Ingredient

ELTROMBOPAG OLAMINE

Application Number

220033

Product Number

1

Dosage Form

-

Strength

EQ 12.5MG ACID

Approval Date

2026-04-08

Regulatory Status

RX

2026
08 Apr
RX Application: 220033

Drug Name

ELTROMBOPAG OLAMINE

Product Number

2

Dosage Form

-

Strength

EQ 25MG ACID

Approval Date

2026-04-08

220033 / 2

Active Ingredient

ELTROMBOPAG OLAMINE

Application Number

220033

Product Number

2

Dosage Form

-

Strength

EQ 25MG ACID

Approval Date

2026-04-08

Regulatory Status

RX

2026
08 Apr
RX Application: 220033

Drug Name

ELTROMBOPAG OLAMINE

Product Number

3

Dosage Form

-

Strength

EQ 50MG ACID

Approval Date

2026-04-08

220033 / 3

Active Ingredient

ELTROMBOPAG OLAMINE

Application Number

220033

Product Number

3

Dosage Form

-

Strength

EQ 50MG ACID

Approval Date

2026-04-08

Regulatory Status

RX

2026
08 Apr
RX Application: 220033

Drug Name

ELTROMBOPAG OLAMINE

Product Number

4

Dosage Form

-

Strength

EQ 75MG ACID

Approval Date

2026-04-08

220033 / 4

Active Ingredient

ELTROMBOPAG OLAMINE

Application Number

220033

Product Number

4

Dosage Form

-

Strength

EQ 75MG ACID

Approval Date

2026-04-08

Regulatory Status

RX

1995
31 Mar
Discontinued Application: 74221

Drug Name

EMBELINE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

1995-03-31

74221 / 1

Active Ingredient

CLOBETASOL PROPIONATE

Application Number

74221

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

1995-03-31

Regulatory Status

Discontinued

1995
06 Dec
Discontinued Application: 74222

Drug Name

EMBELINE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

1995-12-06

74222 / 1

Active Ingredient

CLOBETASOL PROPIONATE

Application Number

74222

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

1995-12-06

Regulatory Status

Discontinued

2002
12 Apr
Discontinued Application: 76141

Drug Name

EMBELINE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2002-04-12

76141 / 1

Active Ingredient

CLOBETASOL PROPIONATE

Application Number

76141

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2002-04-12

Regulatory Status

Discontinued

1998
24 Dec
Discontinued Application: 75325

Drug Name

EMBELINE E

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

1998-12-24

75325 / 1

Active Ingredient

CLOBETASOL PROPIONATE

Application Number

75325

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

1998-12-24

Regulatory Status

Discontinued

2008
23 Dec
RX Application: 78687

Drug Name

ENALAPRILAT

Product Number

1

Dosage Form

-

Strength

1.25MG/ML

Approval Date

2008-12-23

78687 / 1

Active Ingredient

ENALAPRILAT

Application Number

78687

Product Number

1

Dosage Form

-

Strength

1.25MG/ML

Approval Date

2008-12-23

Regulatory Status

RX

-
Unclassified Application: 761439

Drug Name

ENOBY

Product Number

1

Dosage Form

-

Strength

60MG/ML

Approval Date

-

761439 / 1

Active Ingredient

DENOSUMAB-QBDE

Application Number

761439

Product Number

1

Dosage Form

-

Strength

60MG/ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 218731

Drug Name

ENZALUTAMIDE

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

-

218731 / 1

Active Ingredient

ENZALUTAMIDE

Application Number

218731

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 218731

Drug Name

ENZALUTAMIDE

Product Number

2

Dosage Form

-

Strength

80MG

Approval Date

-

218731 / 2

Active Ingredient

ENZALUTAMIDE

Application Number

218731

Product Number

2

Dosage Form

-

Strength

80MG

Approval Date

-

Regulatory Status

Unclassified

2020
15 Dec
RX Application: 214334

Drug Name

EPHEDRINE SULFATE

Product Number

1

Dosage Form

-

Strength

50MG/ML (50MG/ML)

Approval Date

2020-12-15

214334 / 1

Active Ingredient

EPHEDRINE SULFATE

Application Number

214334

Product Number

1

Dosage Form

-

Strength

50MG/ML (50MG/ML)

Approval Date

2020-12-15

Regulatory Status

RX

2024
11 Oct
RX Application: 217721

Drug Name

EPHEDRINE SULFATE

Product Number

1

Dosage Form

-

Strength

25MG/5ML (5MG/ML)

Approval Date

2024-10-11

217721 / 1

Active Ingredient

EPHEDRINE SULFATE

Application Number

217721

Product Number

1

Dosage Form

-

Strength

25MG/5ML (5MG/ML)

Approval Date

2024-10-11

Regulatory Status

RX

2026
29 May
RX Application: 220562

Drug Name

EPINEPHRINE

Product Number

1

Dosage Form

-

Strength

1MG/ML (1MG/ML)

Approval Date

2026-05-29

220562 / 1

Active Ingredient

EPINEPHRINE

Application Number

220562

Product Number

1

Dosage Form

-

Strength

1MG/ML (1MG/ML)

Approval Date

2026-05-29

Regulatory Status

RX

2007
27 Jun
RX Application: 65289

Drug Name

EPIRUBICIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG/25ML (2MG/ML)

Approval Date

2007-06-27

65289 / 1

Active Ingredient

EPIRUBICIN HYDROCHLORIDE

Application Number

65289

Product Number

1

Dosage Form

-

Strength

50MG/25ML (2MG/ML)

Approval Date

2007-06-27

Regulatory Status

RX

2007
27 Jun
RX Application: 65289

Drug Name

EPIRUBICIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

200MG/100ML (2MG/ML)

Approval Date

2007-06-27

65289 / 2

Active Ingredient

EPIRUBICIN HYDROCHLORIDE

Application Number

65289

Product Number

2

Dosage Form

-

Strength

200MG/100ML (2MG/ML)

Approval Date

2007-06-27

Regulatory Status

RX

2004
17 Sep
Discontinued Application: 40510

Drug Name

ERGOTAMINE TARTRATE AND CAFFEINE

Product Number

1

Dosage Form

-

Strength

100MG;1MG

Approval Date

2004-09-17

40510 / 1

Active Ingredient

CAFFEINE; ERGOTAMINE TARTRATE

Application Number

40510

Product Number

1

Dosage Form

-

Strength

100MG;1MG

Approval Date

2004-09-17

Regulatory Status

Discontinued

2025
21 Jan
Discontinued Application: 216842

Drug Name

ERTUGLIFLOZIN

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2025-01-21

216842 / 1

Active Ingredient

ERTUGLIFLOZIN

Application Number

216842

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2025-01-21

Regulatory Status

Discontinued

2025
21 Jan
Discontinued Application: 216842

Drug Name

ERTUGLIFLOZIN

Product Number

2

Dosage Form

-

Strength

15MG

Approval Date

2025-01-21

216842 / 2

Active Ingredient

ERTUGLIFLOZIN

Application Number

216842

Product Number

2

Dosage Form

-

Strength

15MG

Approval Date

2025-01-21

Regulatory Status

Discontinued

2012
11 Sep
Discontinued Application: 78766

Drug Name

ESCITALOPRAM OXALATE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2012-09-11

78766 / 1

Active Ingredient

ESCITALOPRAM OXALATE

Application Number

78766

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2012-09-11

Regulatory Status

Discontinued

2012
11 Sep
Discontinued Application: 78766

Drug Name

ESCITALOPRAM OXALATE

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2012-09-11

78766 / 2

Active Ingredient

ESCITALOPRAM OXALATE

Application Number

78766

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2012-09-11

Regulatory Status

Discontinued

2012
11 Sep
Discontinued Application: 78766

Drug Name

ESCITALOPRAM OXALATE

Product Number

3

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2012-09-11

78766 / 3

Active Ingredient

ESCITALOPRAM OXALATE

Application Number

78766

Product Number

3

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2012-09-11

Regulatory Status

Discontinued

2004
10 Aug
RX Application: 76323

Drug Name

ESMOLOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2004-08-10

76323 / 1

Active Ingredient

ESMOLOL HYDROCHLORIDE

Application Number

76323

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2004-08-10

Regulatory Status

RX

2020
21 Apr
RX Application: 203723

Drug Name

ESTRADIOL VALERATE

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2020-04-21

203723 / 1

Active Ingredient

ESTRADIOL VALERATE

Application Number

203723

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2020-04-21

Regulatory Status

RX

2020
21 Apr
RX Application: 203723

Drug Name

ESTRADIOL VALERATE

Product Number

2

Dosage Form

-

Strength

20MG/ML

Approval Date

2020-04-21

203723 / 2

Active Ingredient

ESTRADIOL VALERATE

Application Number

203723

Product Number

2

Dosage Form

-

Strength

20MG/ML

Approval Date

2020-04-21

Regulatory Status

RX

2020
21 Apr
RX Application: 203723

Drug Name

ESTRADIOL VALERATE

Product Number

3

Dosage Form

-

Strength

40MG/ML

Approval Date

2020-04-21

203723 / 3

Active Ingredient

ESTRADIOL VALERATE

Application Number

203723

Product Number

3

Dosage Form

-

Strength

40MG/ML

Approval Date

2020-04-21

Regulatory Status

RX

2014
15 Apr
Discontinued Application: 91153

Drug Name

ESZOPICLONE

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2014-04-15

91153 / 1

Active Ingredient

ESZOPICLONE

Application Number

91153

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2014-04-15

Regulatory Status

Discontinued

2014
15 Apr
Discontinued Application: 91153

Drug Name

ESZOPICLONE

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2014-04-15

91153 / 2

Active Ingredient

ESZOPICLONE

Application Number

91153

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2014-04-15

Regulatory Status

Discontinued

2014
15 Apr
Discontinued Application: 91153

Drug Name

ESZOPICLONE

Product Number

3

Dosage Form

-

Strength

3MG

Approval Date

2014-04-15

91153 / 3

Active Ingredient

ESZOPICLONE

Application Number

91153

Product Number

3

Dosage Form

-

Strength

3MG

Approval Date

2014-04-15

Regulatory Status

Discontinued

2017
23 Feb
Discontinued Application: 207262

Drug Name

ETHACRYNIC ACID

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2017-02-23

207262 / 1

Active Ingredient

ETHACRYNIC ACID

Application Number

207262

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2017-02-23

Regulatory Status

Discontinued

1996
04 Nov
RX Application: 74593

Drug Name

ETOMIDATE

Product Number

1

Dosage Form

-

Strength

2MG/ML

Approval Date

1996-11-04

74593 / 1

Active Ingredient

ETOMIDATE

Application Number

74593

Product Number

1

Dosage Form

-

Strength

2MG/ML

Approval Date

1996-11-04

Regulatory Status

RX

2016
25 Feb
RX Application: 202354

Drug Name

ETOMIDATE

Product Number

1

Dosage Form

-

Strength

2MG/ML

Approval Date

2016-02-25

202354 / 1

Active Ingredient

ETOMIDATE

Application Number

202354

Product Number

1

Dosage Form

-

Strength

2MG/ML

Approval Date

2016-02-25

Regulatory Status

RX

1995
17 Jul
RX Application: 74290

Drug Name

ETOPOSIDE

Product Number

1

Dosage Form

-

Strength

20MG/ML

Approval Date

1995-07-17

74290 / 1

Active Ingredient

ETOPOSIDE

Application Number

74290

Product Number

1

Dosage Form

-

Strength

20MG/ML

Approval Date

1995-07-17

Regulatory Status

RX

2018
12 Apr
RX Application: 206133

Drug Name

EVEROLIMUS

Product Number

1

Dosage Form

-

Strength

0.25MG

Approval Date

2018-04-12

206133 / 1

Active Ingredient

EVEROLIMUS

Application Number

206133

Product Number

1

Dosage Form

-

Strength

0.25MG

Approval Date

2018-04-12

Regulatory Status

RX

2018
12 Apr
RX Application: 206133

Drug Name

EVEROLIMUS

Product Number

2

Dosage Form

-

Strength

0.5MG

Approval Date

2018-04-12

206133 / 2

Active Ingredient

EVEROLIMUS

Application Number

206133

Product Number

2

Dosage Form

-

Strength

0.5MG

Approval Date

2018-04-12

Regulatory Status

RX

2018
12 Apr
RX Application: 206133

Drug Name

EVEROLIMUS

Product Number

3

Dosage Form

-

Strength

0.75MG

Approval Date

2018-04-12

206133 / 3

Active Ingredient

EVEROLIMUS

Application Number

206133

Product Number

3

Dosage Form

-

Strength

0.75MG

Approval Date

2018-04-12

Regulatory Status

RX

2021
18 Nov
RX Application: 206133

Drug Name

EVEROLIMUS

Product Number

4

Dosage Form

-

Strength

1MG

Approval Date

2021-11-18

206133 / 4

Active Ingredient

EVEROLIMUS

Application Number

206133

Product Number

4

Dosage Form

-

Strength

1MG

Approval Date

2021-11-18

Regulatory Status

RX

2020
08 Jun
RX Application: 207486

Drug Name

EVEROLIMUS

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2020-06-08

207486 / 1

Active Ingredient

EVEROLIMUS

Application Number

207486

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2020-06-08

Regulatory Status

RX

2020
08 Jun
RX Application: 207486

Drug Name

EVEROLIMUS

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2020-06-08

207486 / 2

Active Ingredient

EVEROLIMUS

Application Number

207486

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2020-06-08

Regulatory Status

RX

2020
08 Jun
RX Application: 207486

Drug Name

EVEROLIMUS

Product Number

3

Dosage Form

-

Strength

7.5MG

Approval Date

2020-06-08

207486 / 3

Active Ingredient

EVEROLIMUS

Application Number

207486

Product Number

3

Dosage Form

-

Strength

7.5MG

Approval Date

2020-06-08

Regulatory Status

RX

2021
23 Nov
RX Application: 207486

Drug Name

EVEROLIMUS

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2021-11-23

207486 / 4

Active Ingredient

EVEROLIMUS

Application Number

207486

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2021-11-23

Regulatory Status

RX

2011
01 Apr
Discontinued Application: 77431

Drug Name

EXEMESTANE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2011-04-01

77431 / 1

Active Ingredient

EXEMESTANE

Application Number

77431

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2011-04-01

Regulatory Status

Discontinued

1982
30 Sep
Discontinued Application: 18123

Drug Name

FACTREL

Product Number

1

Dosage Form

-

Strength

EQ 0.1MG BASE/VIAL

Approval Date

1982-09-30

18123 / 1

Active Ingredient

GONADORELIN HYDROCHLORIDE

Application Number

18123

Product Number

1

Dosage Form

-

Strength

EQ 0.1MG BASE/VIAL

Approval Date

1982-09-30

Regulatory Status

Discontinued

1982
30 Sep
Discontinued Application: 18123

Drug Name

FACTREL

Product Number

2

Dosage Form

-

Strength

EQ 0.2MG BASE/VIAL

Approval Date

1982-09-30

18123 / 2

Active Ingredient

GONADORELIN HYDROCHLORIDE

Application Number

18123

Product Number

2

Dosage Form

-

Strength

EQ 0.2MG BASE/VIAL

Approval Date

1982-09-30

Regulatory Status

Discontinued

1982
30 Sep
Discontinued Application: 18123

Drug Name

FACTREL

Product Number

3

Dosage Form

-

Strength

EQ 0.5MG BASE/VIAL

Approval Date

1982-09-30

18123 / 3

Active Ingredient

GONADORELIN HYDROCHLORIDE

Application Number

18123

Product Number

3

Dosage Form

-

Strength

EQ 0.5MG BASE/VIAL

Approval Date

1982-09-30

Regulatory Status

Discontinued

2011
21 Mar
Discontinued Application: 90128

Drug Name

FAMCICLOVIR

Product Number

1

Dosage Form

-

Strength

125MG

Approval Date

2011-03-21

90128 / 1

Active Ingredient

FAMCICLOVIR

Application Number

90128

Product Number

1

Dosage Form

-

Strength

125MG

Approval Date

2011-03-21

Regulatory Status

Discontinued

2011
21 Mar
Discontinued Application: 90128

Drug Name

FAMCICLOVIR

Product Number

2

Dosage Form

-

Strength

250MG

Approval Date

2011-03-21

90128 / 2

Active Ingredient

FAMCICLOVIR

Application Number

90128

Product Number

2

Dosage Form

-

Strength

250MG

Approval Date

2011-03-21

Regulatory Status

Discontinued

2011
21 Mar
Discontinued Application: 90128

Drug Name

FAMCICLOVIR

Product Number

3

Dosage Form

-

Strength

500MG

Approval Date

2011-03-21

90128 / 3

Active Ingredient

FAMCICLOVIR

Application Number

90128

Product Number

3

Dosage Form

-

Strength

500MG

Approval Date

2011-03-21

Regulatory Status

Discontinued

2001
16 Apr
RX Application: 75488

Drug Name

FAMOTIDINE

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2001-04-16

75488 / 1

Active Ingredient

FAMOTIDINE

Application Number

75488

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2001-04-16

Regulatory Status

RX

2002
30 Apr
Discontinued Application: 75799

Drug Name

FAMOTIDINE

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2002-04-30

75799 / 1

Active Ingredient

FAMOTIDINE

Application Number

75799

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2002-04-30

Regulatory Status

Discontinued

2001
16 Apr
RX Application: 75486

Drug Name

FAMOTIDINE PRESERVATIVE FREE

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2001-04-16

75486 / 1

Active Ingredient

FAMOTIDINE

Application Number

75486

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2001-04-16

Regulatory Status

RX

2002
30 Apr
Discontinued Application: 75789

Drug Name

FAMOTIDINE PRESERVATIVE FREE

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2002-04-30

75789 / 1

Active Ingredient

FAMOTIDINE

Application Number

75789

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2002-04-30

Regulatory Status

Discontinued

2019
15 Oct
RX Application: 205414

Drug Name

FEBUXOSTAT

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2019-10-15

205414 / 1

Active Ingredient

FEBUXOSTAT

Application Number

205414

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2019-10-15

Regulatory Status

RX

2019
15 Oct
RX Application: 205414

Drug Name

FEBUXOSTAT

Product Number

2

Dosage Form

-

Strength

80MG

Approval Date

2019-10-15

205414 / 2

Active Ingredient

FEBUXOSTAT

Application Number

205414

Product Number

2

Dosage Form

-

Strength

80MG

Approval Date

2019-10-15

Regulatory Status

RX

2004
12 Oct
Discontinued Application: 76582

Drug Name

FENOLDOPAM MESYLATE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

2004-10-12

76582 / 1

Active Ingredient

FENOLDOPAM MESYLATE

Application Number

76582

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

2004-10-12

Regulatory Status

Discontinued

1984
11 Jul
RX Application: 19101

Drug Name

FENTANYL CITRATE

Product Number

1

Dosage Form

-

Strength

EQ 0.05MG BASE/ML

Approval Date

1984-07-11

19101 / 1

Active Ingredient

FENTANYL CITRATE

Application Number

19101

Product Number

1

Dosage Form

-

Strength

EQ 0.05MG BASE/ML

Approval Date

1984-07-11

Regulatory Status

RX

2023
20 Jan
RX Application: 19101

Drug Name

FENTANYL CITRATE

Product Number

2

Dosage Form

-

Strength

EQ 0.025MG BASE/0.5ML

Approval Date

2023-01-20

19101 / 2

Active Ingredient

FENTANYL CITRATE

Application Number

19101

Product Number

2

Dosage Form

-

Strength

EQ 0.025MG BASE/0.5ML

Approval Date

2023-01-20

Regulatory Status

RX

2003
14 Jan
RX Application: 76278

Drug Name

FLECAINIDE ACETATE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2003-01-14

76278 / 1

Active Ingredient

FLECAINIDE ACETATE

Application Number

76278

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2003-01-14

Regulatory Status

RX

2003
14 Jan
RX Application: 76278

Drug Name

FLECAINIDE ACETATE

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2003-01-14

76278 / 2

Active Ingredient

FLECAINIDE ACETATE

Application Number

76278

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2003-01-14

Regulatory Status

RX

2003
14 Jan
RX Application: 76278

Drug Name

FLECAINIDE ACETATE

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2003-01-14

76278 / 3

Active Ingredient

FLECAINIDE ACETATE

Application Number

76278

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2003-01-14

Regulatory Status

RX

2000
16 Apr
RX Application: 75387

Drug Name

FLOXURIDINE

Product Number

1

Dosage Form

-

Strength

500MG/VIAL

Approval Date

2000-04-16

75387 / 1

Active Ingredient

FLOXURIDINE

Application Number

75387

Product Number

1

Dosage Form

-

Strength

500MG/VIAL

Approval Date

2000-04-16

Regulatory Status

RX

2004
29 Jul
Discontinued Application: 76246

Drug Name

FLUCONAZOLE

Product Number

1

Dosage Form

-

Strength

50MG/5ML

Approval Date

2004-07-29

76246 / 1

Active Ingredient

FLUCONAZOLE

Application Number

76246

Product Number

1

Dosage Form

-

Strength

50MG/5ML

Approval Date

2004-07-29

Regulatory Status

Discontinued

2004
29 Jul
Discontinued Application: 76246

Drug Name

FLUCONAZOLE

Product Number

2

Dosage Form

-

Strength

200MG/5ML

Approval Date

2004-07-29

76246 / 2

Active Ingredient

FLUCONAZOLE

Application Number

76246

Product Number

2

Dosage Form

-

Strength

200MG/5ML

Approval Date

2004-07-29

Regulatory Status

Discontinued

2012
30 Jan
Discontinued Application: 78764

Drug Name

FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

200MG/100ML (2MG/ML)

Approval Date

2012-01-30

78764 / 1

Active Ingredient

FLUCONAZOLE

Application Number

78764

Product Number

1

Dosage Form

-

Strength

200MG/100ML (2MG/ML)

Approval Date

2012-01-30

Regulatory Status

Discontinued

2012
30 Jan
Discontinued Application: 78764

Drug Name

FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

400MG/200ML (2MG/ML)

Approval Date

2012-01-30

78764 / 2

Active Ingredient

FLUCONAZOLE

Application Number

78764

Product Number

2

Dosage Form

-

Strength

400MG/200ML (2MG/ML)

Approval Date

2012-01-30

Regulatory Status

Discontinued

2004
29 Jul
RX Application: 76087

Drug Name

FLUCONAZOLE IN SODIUM CHLORIDE 0.9%

Product Number

1

Dosage Form

-

Strength

200MG/100ML (2MG/ML)

Approval Date

2004-07-29

76087 / 1

Active Ingredient

FLUCONAZOLE

Application Number

76087

Product Number

1

Dosage Form

-

Strength

200MG/100ML (2MG/ML)

Approval Date

2004-07-29

Regulatory Status

RX

2008
26 Sep
RX Application: 76087

Drug Name

FLUCONAZOLE IN SODIUM CHLORIDE 0.9%

Product Number

2

Dosage Form

-

Strength

100MG/50ML (2MG/ML)

Approval Date

2008-09-26

76087 / 2

Active Ingredient

FLUCONAZOLE

Application Number

76087

Product Number

2

Dosage Form

-

Strength

100MG/50ML (2MG/ML)

Approval Date

2008-09-26

Regulatory Status

RX

2004
29 Jul
RX Application: 76087

Drug Name

FLUCONAZOLE IN SODIUM CHLORIDE 0.9%

Product Number

3

Dosage Form

-

Strength

400MG/200ML (2MG/ML)

Approval Date

2004-07-29

76087 / 3

Active Ingredient

FLUCONAZOLE

Application Number

76087

Product Number

3

Dosage Form

-

Strength

400MG/200ML (2MG/ML)

Approval Date

2004-07-29

Regulatory Status

RX

2005
23 Aug
RX Application: 76736

Drug Name

FLUCONAZOLE IN SODIUM CHLORIDE 0.9%

Product Number

1

Dosage Form

-

Strength

200MG/100ML (2MG/ML)

Approval Date

2005-08-23

76736 / 1

Active Ingredient

FLUCONAZOLE

Application Number

76736

Product Number

1

Dosage Form

-

Strength

200MG/100ML (2MG/ML)

Approval Date

2005-08-23

Regulatory Status

RX

2008
30 Jul
RX Application: 78107

Drug Name

FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

200MG/100ML (2MG/ML)

Approval Date

2008-07-30

78107 / 1

Active Ingredient

FLUCONAZOLE

Application Number

78107

Product Number

1

Dosage Form

-

Strength

200MG/100ML (2MG/ML)

Approval Date

2008-07-30

Regulatory Status

RX

2008
30 Jul
RX Application: 78107

Drug Name

FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

400MG/200ML (2MG/ML)

Approval Date

2008-07-30

78107 / 2

Active Ingredient

FLUCONAZOLE

Application Number

78107

Product Number

2

Dosage Form

-

Strength

400MG/200ML (2MG/ML)

Approval Date

2008-07-30

Regulatory Status

RX

2012
30 Jan
RX Application: 78698

Drug Name

FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

200MG/100ML (2MG/ML)

Approval Date

2012-01-30

78698 / 1

Active Ingredient

FLUCONAZOLE

Application Number

78698

Product Number

1

Dosage Form

-

Strength

200MG/100ML (2MG/ML)

Approval Date

2012-01-30

Regulatory Status

RX

2012
30 Jan
RX Application: 78698

Drug Name

FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

400MG/200ML (2MG/ML)

Approval Date

2012-01-30

78698 / 2

Active Ingredient

FLUCONAZOLE

Application Number

78698

Product Number

2

Dosage Form

-

Strength

400MG/200ML (2MG/ML)

Approval Date

2012-01-30

Regulatory Status

RX

2017
17 Oct
Discontinued Application: 206550

Drug Name

FLUCYTOSINE

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2017-10-17

206550 / 1

Active Ingredient

FLUCYTOSINE

Application Number

206550

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2017-10-17

Regulatory Status

Discontinued

2017
17 Oct
Discontinued Application: 206550

Drug Name

FLUCYTOSINE

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2017-10-17

206550 / 2

Active Ingredient

FLUCYTOSINE

Application Number

206550

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2017-10-17

Regulatory Status

Discontinued

2003
28 Aug
RX Application: 76349

Drug Name

FLUDARABINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

50MG/VIAL

Approval Date

2003-08-28

76349 / 1

Active Ingredient

FLUDARABINE PHOSPHATE

Application Number

76349

Product Number

1

Dosage Form

-

Strength

50MG/VIAL

Approval Date

2003-08-28

Regulatory Status

RX

2011
22 Jul
Discontinued Application: 91302

Drug Name

FLUDROCORTISONE ACETATE

Product Number

1

Dosage Form

-

Strength

0.1MG

Approval Date

2011-07-22

91302 / 1

Active Ingredient

FLUDROCORTISONE ACETATE

Application Number

91302

Product Number

1

Dosage Form

-

Strength

0.1MG

Approval Date

2011-07-22

Regulatory Status

Discontinued

2004
12 Oct
RX Application: 76256

Drug Name

FLUMAZENIL

Product Number

1

Dosage Form

-

Strength

1MG/10ML (0.1MG/ML)

Approval Date

2004-10-12

76256 / 1

Active Ingredient

FLUMAZENIL

Application Number

76256

Product Number

1

Dosage Form

-

Strength

1MG/10ML (0.1MG/ML)

Approval Date

2004-10-12

Regulatory Status

RX

2004
12 Oct
RX Application: 76256

Drug Name

FLUMAZENIL

Product Number

2

Dosage Form

-

Strength

0.5MG/5ML (0.1MG/ML)

Approval Date

2004-10-12

76256 / 2

Active Ingredient

FLUMAZENIL

Application Number

76256

Product Number

2

Dosage Form

-

Strength

0.5MG/5ML (0.1MG/ML)

Approval Date

2004-10-12

Regulatory Status

RX

2004
12 Oct
Discontinued Application: 76787

Drug Name

FLUMAZENIL

Product Number

1

Dosage Form

-

Strength

1MG/10ML (0.1MG/ML)

Approval Date

2004-10-12

76787 / 1

Active Ingredient

FLUMAZENIL

Application Number

76787

Product Number

1

Dosage Form

-

Strength

1MG/10ML (0.1MG/ML)

Approval Date

2004-10-12

Regulatory Status

Discontinued

2004
12 Oct
Discontinued Application: 76787

Drug Name

FLUMAZENIL

Product Number

2

Dosage Form

-

Strength

0.5MG/5ML (0.1MG/ML)

Approval Date

2004-10-12

76787 / 2

Active Ingredient

FLUMAZENIL

Application Number

76787

Product Number

2

Dosage Form

-

Strength

0.5MG/5ML (0.1MG/ML)

Approval Date

2004-10-12

Regulatory Status

Discontinued

2009
23 Mar
RX Application: 78527

Drug Name

FLUMAZENIL

Product Number

1

Dosage Form

-

Strength

0.5MG/5ML (0.1MG/ML)

Approval Date

2009-03-23

78527 / 1

Active Ingredient

FLUMAZENIL

Application Number

78527

Product Number

1

Dosage Form

-

Strength

0.5MG/5ML (0.1MG/ML)

Approval Date

2009-03-23

Regulatory Status

RX

2009
23 Mar
RX Application: 78527

Drug Name

FLUMAZENIL

Product Number

2

Dosage Form

-

Strength

1MG/10ML (0.1MG/ML)

Approval Date

2009-03-23

78527 / 2

Active Ingredient

FLUMAZENIL

Application Number

78527

Product Number

2

Dosage Form

-

Strength

1MG/10ML (0.1MG/ML)

Approval Date

2009-03-23

Regulatory Status

RX

1996
30 Aug
RX Application: 74531

Drug Name

FLUPHENAZINE DECANOATE

Product Number

1

Dosage Form

-

Strength

25MG/ML

Approval Date

1996-08-30

74531 / 1

Active Ingredient

FLUPHENAZINE DECANOATE

Application Number

74531

Product Number

1

Dosage Form

-

Strength

25MG/ML

Approval Date

1996-08-30

Regulatory Status

RX

-
Unclassified Application: 71107

Drug Name

FLURAZEPAM HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

-

71107 / 1

Active Ingredient

FLURAZEPAM HYDROCHLORIDE

Application Number

71107

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

-

Regulatory Status

Unclassified

1986
08 Dec
Discontinued Application: 71108

Drug Name

FLURAZEPAM HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

1986-12-08

71108 / 1

Active Ingredient

FLURAZEPAM HYDROCHLORIDE

Application Number

71108

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

1986-12-08

Regulatory Status

Discontinued

1986
08 Dec
Discontinued Application: 71108

Drug Name

FLURAZEPAM HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

15MG

Approval Date

1986-12-08

71108 / 2

Active Ingredient

FLURAZEPAM HYDROCHLORIDE

Application Number

71108

Product Number

2

Dosage Form

-

Strength

15MG

Approval Date

1986-12-08

Regulatory Status

Discontinued

2006
22 Feb
RX Application: 76504

Drug Name

FLUTICASONE PROPIONATE

Product Number

1

Dosage Form

-

Strength

0.05MG/SPRAY

Approval Date

2006-02-22

76504 / 1

Active Ingredient

FLUTICASONE PROPIONATE

Application Number

76504

Product Number

1

Dosage Form

-

Strength

0.05MG/SPRAY

Approval Date

2006-02-22

Regulatory Status

RX

2008
16 Jan
Discontinued Application: 77570

Drug Name

FLUTICASONE PROPIONATE

Product Number

1

Dosage Form

-

Strength

0.05MG/SPRAY

Approval Date

2008-01-16

77570 / 1

Active Ingredient

FLUTICASONE PROPIONATE

Application Number

77570

Product Number

1

Dosage Form

-

Strength

0.05MG/SPRAY

Approval Date

2008-01-16

Regulatory Status

Discontinued

2016
26 May
OTC Application: 207957

Drug Name

FLUTICASONE PROPIONATE

Product Number

1

Dosage Form

-

Strength

0.05MG/SPRAY

Approval Date

2016-05-26

207957 / 1

Active Ingredient

FLUTICASONE PROPIONATE

Application Number

207957

Product Number

1

Dosage Form

-

Strength

0.05MG/SPRAY

Approval Date

2016-05-26

Regulatory Status

OTC

2019
17 Apr
Discontinued Application: 208024

Drug Name

FLUTICASONE PROPIONATE

Product Number

1

Dosage Form

-

Strength

0.05MG/SPRAY

Approval Date

2019-04-17

208024 / 1

Active Ingredient

FLUTICASONE PROPIONATE

Application Number

208024

Product Number

1

Dosage Form

-

Strength

0.05MG/SPRAY

Approval Date

2019-04-17

Regulatory Status

Discontinued

2020
17 Dec
RX Application: 203433

Drug Name

FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE

Product Number

1

Dosage Form

-

Strength

0.1MG/INH;EQ 0.05MG BASE/INH

Approval Date

2020-12-17

203433 / 1

Active Ingredient

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

Application Number

203433

Product Number

1

Dosage Form

-

Strength

0.1MG/INH;EQ 0.05MG BASE/INH

Approval Date

2020-12-17

Regulatory Status

RX

2020
17 Dec
RX Application: 203433

Drug Name

FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE

Product Number

2

Dosage Form

-

Strength

0.25MG/INH;EQ 0.05MG BASE/INH

Approval Date

2020-12-17

203433 / 2

Active Ingredient

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

Application Number

203433

Product Number

2

Dosage Form

-

Strength

0.25MG/INH;EQ 0.05MG BASE/INH

Approval Date

2020-12-17

Regulatory Status

RX

2023
19 Dec
RX Application: 203433

Drug Name

FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE

Product Number

3

Dosage Form

-

Strength

0.5MG/INH;EQ 0.05MG BASE/INH

Approval Date

2023-12-19

203433 / 3

Active Ingredient

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

Application Number

203433

Product Number

3

Dosage Form

-

Strength

0.5MG/INH;EQ 0.05MG BASE/INH

Approval Date

2023-12-19

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 80600

Drug Name

FOLIC ACID

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

1982-01-01

80600 / 1

Active Ingredient

FOLIC ACID

Application Number

80600

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2007
06 Aug
RX Application: 77481

Drug Name

FOSPHENYTOIN SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 50MG PHENYTOIN NA/ML

Approval Date

2007-08-06

77481 / 1

Active Ingredient

FOSPHENYTOIN SODIUM

Application Number

77481

Product Number

1

Dosage Form

-

Strength

EQ 50MG PHENYTOIN NA/ML

Approval Date

2007-08-06

Regulatory Status

RX

2007
06 Aug
RX Application: 77989

Drug Name

FOSPHENYTOIN SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 50MG PHENYTOIN NA/ML

Approval Date

2007-08-06

77989 / 1

Active Ingredient

FOSPHENYTOIN SODIUM

Application Number

77989

Product Number

1

Dosage Form

-

Strength

EQ 50MG PHENYTOIN NA/ML

Approval Date

2007-08-06

Regulatory Status

RX

2009
02 Dec
RX Application: 78765

Drug Name

FOSPHENYTOIN SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 50MG PHENYTOIN NA/ML

Approval Date

2009-12-02

78765 / 1

Active Ingredient

FOSPHENYTOIN SODIUM

Application Number

78765

Product Number

1

Dosage Form

-

Strength

EQ 50MG PHENYTOIN NA/ML

Approval Date

2009-12-02

Regulatory Status

RX

1982
01 Jan
RX Application: 18267

Drug Name

FUROSEMIDE

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1982-01-01

18267 / 1

Active Ingredient

FUROSEMIDE

Application Number

18267

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1982-01-01

Regulatory Status

RX

1983
10 Nov
RX Application: 18823

Drug Name

FUROSEMIDE

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

1983-11-10

18823 / 1

Active Ingredient

FUROSEMIDE

Application Number

18823

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

1983-11-10

Regulatory Status

RX

1983
10 Nov
RX Application: 18823

Drug Name

FUROSEMIDE

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

1983-11-10

18823 / 2

Active Ingredient

FUROSEMIDE

Application Number

18823

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

1983-11-10

Regulatory Status

RX

1986
24 Jan
RX Application: 70086

Drug Name

FUROSEMIDE

Product Number

1

Dosage Form

-

Strength

80MG

Approval Date

1986-01-24

70086 / 1

Active Ingredient

FUROSEMIDE

Application Number

70086

Product Number

1

Dosage Form

-

Strength

80MG

Approval Date

1986-01-24

Regulatory Status

RX

1987
22 Apr
RX Application: 70433

Drug Name

FUROSEMIDE

Product Number

1

Dosage Form

-

Strength

40MG/5ML

Approval Date

1987-04-22

70433 / 1

Active Ingredient

FUROSEMIDE

Application Number

70433

Product Number

1

Dosage Form

-

Strength

40MG/5ML

Approval Date

1987-04-22

Regulatory Status

RX

1987
22 Apr
RX Application: 70434

Drug Name

FUROSEMIDE

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1987-04-22

70434 / 1

Active Ingredient

FUROSEMIDE

Application Number

70434

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1987-04-22

Regulatory Status

RX

1990
14 Sep
Discontinued Application: 71439

Drug Name

FUROSEMIDE

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1990-09-14

71439 / 1

Active Ingredient

FUROSEMIDE

Application Number

71439

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1990-09-14

Regulatory Status

Discontinued

2007
25 Sep
Discontinued Application: 78150

Drug Name

GABAPENTIN

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2007-09-25

78150 / 1

Active Ingredient

GABAPENTIN

Application Number

78150

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2007-09-25

Regulatory Status

Discontinued

2007
25 Sep
Discontinued Application: 78150

Drug Name

GABAPENTIN

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2007-09-25

78150 / 2

Active Ingredient

GABAPENTIN

Application Number

78150

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2007-09-25

Regulatory Status

Discontinued

2007
25 Sep
Discontinued Application: 78150

Drug Name

GABAPENTIN

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

2007-09-25

78150 / 3

Active Ingredient

GABAPENTIN

Application Number

78150

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

2007-09-25

Regulatory Status

Discontinued

2011
21 Jul
Discontinued Application: 78782

Drug Name

GABAPENTIN

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2011-07-21

78782 / 1

Active Ingredient

GABAPENTIN

Application Number

78782

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2011-07-21

Regulatory Status

Discontinued

2011
21 Jul
Discontinued Application: 78782

Drug Name

GABAPENTIN

Product Number

2

Dosage Form

-

Strength

800MG

Approval Date

2011-07-21

78782 / 2

Active Ingredient

GABAPENTIN

Application Number

78782

Product Number

2

Dosage Form

-

Strength

800MG

Approval Date

2011-07-21

Regulatory Status

Discontinued

2009
11 Feb
Discontinued Application: 77608

Drug Name

GALANTAMINE HYDROBROMIDE

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2009-02-11

77608 / 1

Active Ingredient

GALANTAMINE HYDROBROMIDE

Application Number

77608

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2009-02-11

Regulatory Status

Discontinued

2009
11 Feb
Discontinued Application: 77608

Drug Name

GALANTAMINE HYDROBROMIDE

Product Number

2

Dosage Form

-

Strength

EQ 8MG BASE

Approval Date

2009-02-11

77608 / 2

Active Ingredient

GALANTAMINE HYDROBROMIDE

Application Number

77608

Product Number

2

Dosage Form

-

Strength

EQ 8MG BASE

Approval Date

2009-02-11

Regulatory Status

Discontinued

2009
11 Feb
Discontinued Application: 77608

Drug Name

GALANTAMINE HYDROBROMIDE

Product Number

3

Dosage Form

-

Strength

EQ 12MG BASE

Approval Date

2009-02-11

77608 / 3

Active Ingredient

GALANTAMINE HYDROBROMIDE

Application Number

77608

Product Number

3

Dosage Form

-

Strength

EQ 12MG BASE

Approval Date

2009-02-11

Regulatory Status

Discontinued

2009
30 Jan
RX Application: 78185

Drug Name

GALANTAMINE HYDROBROMIDE

Product Number

1

Dosage Form

-

Strength

4MG/ML

Approval Date

2009-01-30

78185 / 1

Active Ingredient

GALANTAMINE HYDROBROMIDE

Application Number

78185

Product Number

1

Dosage Form

-

Strength

4MG/ML

Approval Date

2009-01-30

Regulatory Status

RX

2003
16 Jul
RX Application: 76222

Drug Name

GANCICLOVIR SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2003-07-16

76222 / 1

Active Ingredient

GANCICLOVIR SODIUM

Application Number

76222

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2003-07-16

Regulatory Status

RX

2014
03 Sep
Discontinued Application: 203189

Drug Name

GATIFLOXACIN

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

2014-09-03

203189 / 1

Active Ingredient

GATIFLOXACIN

Application Number

203189

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

2014-09-03

Regulatory Status

Discontinued

2021
25 Jun
Discontinued Application: 206617

Drug Name

GEMCITABINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE/VIAL

Approval Date

2021-06-25

206617 / 1

Active Ingredient

GEMCITABINE HYDROCHLORIDE

Application Number

206617

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE/VIAL

Approval Date

2021-06-25

Regulatory Status

Discontinued

2021
25 Jun
Discontinued Application: 206617

Drug Name

GEMCITABINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2021-06-25

206617 / 2

Active Ingredient

GEMCITABINE HYDROCHLORIDE

Application Number

206617

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2021-06-25

Regulatory Status

Discontinued

2023
07 Mar
RX Application: 213175

Drug Name

GEMCITABINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

200MG/5.26ML (38MG/ML)

Approval Date

2023-03-07

213175 / 1

Active Ingredient

GEMCITABINE HYDROCHLORIDE

Application Number

213175

Product Number

1

Dosage Form

-

Strength

200MG/5.26ML (38MG/ML)

Approval Date

2023-03-07

Regulatory Status

RX

2023
07 Mar
RX Application: 213175

Drug Name

GEMCITABINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

1GM/26.3ML (38MG/ML)

Approval Date

2023-03-07

213175 / 2

Active Ingredient

GEMCITABINE HYDROCHLORIDE

Application Number

213175

Product Number

2

Dosage Form

-

Strength

1GM/26.3ML (38MG/ML)

Approval Date

2023-03-07

Regulatory Status

RX

2023
07 Mar
RX Application: 213175

Drug Name

GEMCITABINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

2GM/52.6ML (38MG/ML)

Approval Date

2023-03-07

213175 / 3

Active Ingredient

GEMCITABINE HYDROCHLORIDE

Application Number

213175

Product Number

3

Dosage Form

-

Strength

2GM/52.6ML (38MG/ML)

Approval Date

2023-03-07

Regulatory Status

RX

2010
16 Aug
Discontinued Application: 78599

Drug Name

GEMFIBROZIL

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2010-08-16

78599 / 1

Active Ingredient

GEMFIBROZIL

Application Number

78599

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2010-08-16

Regulatory Status

Discontinued

1982
01 Jan
RX Application: 62251

Drug Name

GENTAMICIN SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE/ML

Approval Date

1982-01-01

62251 / 1

Active Ingredient

GENTAMICIN SULFATE

Application Number

62251

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE/ML

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 62251

Drug Name

GENTAMICIN SULFATE

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

1982-01-01

62251 / 2

Active Ingredient

GENTAMICIN SULFATE

Application Number

62251

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

1982-01-01

Regulatory Status

RX

2013
01 Aug
Discontinued Application: 78952

Drug Name

GLIMEPIRIDE

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2013-08-01

78952 / 1

Active Ingredient

GLIMEPIRIDE

Application Number

78952

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2013-08-01

Regulatory Status

Discontinued

2013
01 Aug
Discontinued Application: 78952

Drug Name

GLIMEPIRIDE

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2013-08-01

78952 / 2

Active Ingredient

GLIMEPIRIDE

Application Number

78952

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2013-08-01

Regulatory Status

Discontinued

2013
01 Aug
Discontinued Application: 78952

Drug Name

GLIMEPIRIDE

Product Number

3

Dosage Form

-

Strength

4MG

Approval Date

2013-08-01

78952 / 3

Active Ingredient

GLIMEPIRIDE

Application Number

78952

Product Number

3

Dosage Form

-

Strength

4MG

Approval Date

2013-08-01

Regulatory Status

Discontinued

2003
31 Jul
Discontinued Application: 75890

Drug Name

GLYBURIDE (MICRONIZED)

Product Number

1

Dosage Form

-

Strength

1.5MG

Approval Date

2003-07-31

75890 / 1

Active Ingredient

GLYBURIDE

Application Number

75890

Product Number

1

Dosage Form

-

Strength

1.5MG

Approval Date

2003-07-31

Regulatory Status

Discontinued

2003
31 Jul
Discontinued Application: 75890

Drug Name

GLYBURIDE (MICRONIZED)

Product Number

2

Dosage Form

-

Strength

3MG

Approval Date

2003-07-31

75890 / 2

Active Ingredient

GLYBURIDE

Application Number

75890

Product Number

2

Dosage Form

-

Strength

3MG

Approval Date

2003-07-31

Regulatory Status

Discontinued

2003
31 Jul
Discontinued Application: 75890

Drug Name

GLYBURIDE (MICRONIZED)

Product Number

3

Dosage Form

-

Strength

6MG

Approval Date

2003-07-31

75890 / 3

Active Ingredient

GLYBURIDE

Application Number

75890

Product Number

3

Dosage Form

-

Strength

6MG

Approval Date

2003-07-31

Regulatory Status

Discontinued

2009
05 Mar
Discontinued Application: 40836

Drug Name

GLYCOPYRROLATE

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2009-03-05

40836 / 1

Active Ingredient

GLYCOPYRROLATE

Application Number

40836

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2009-03-05

Regulatory Status

Discontinued

2009
05 Mar
Discontinued Application: 40836

Drug Name

GLYCOPYRROLATE

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2009-03-05

40836 / 2

Active Ingredient

GLYCOPYRROLATE

Application Number

40836

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2009-03-05

Regulatory Status

Discontinued

2011
21 Sep
RX Application: 90963

Drug Name

GLYCOPYRROLATE

Product Number

1

Dosage Form

-

Strength

0.2MG/ML

Approval Date

2011-09-21

90963 / 1

Active Ingredient

GLYCOPYRROLATE

Application Number

90963

Product Number

1

Dosage Form

-

Strength

0.2MG/ML

Approval Date

2011-09-21

Regulatory Status

RX

2007
31 Dec
RX Application: 77177

Drug Name

GRANISETRON HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE/4ML (EQ 1MG BASE/ML)

Approval Date

2007-12-31

77177 / 1

Active Ingredient

GRANISETRON HYDROCHLORIDE

Application Number

77177

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE/4ML (EQ 1MG BASE/ML)

Approval Date

2007-12-31

Regulatory Status

RX

2008
30 Jun
RX Application: 77186

Drug Name

GRANISETRON HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE/4ML (EQ 1MG BASE/ML)

Approval Date

2008-06-30

77186 / 1

Active Ingredient

GRANISETRON HYDROCHLORIDE

Application Number

77186

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE/4ML (EQ 1MG BASE/ML)

Approval Date

2008-06-30

Regulatory Status

RX

2008
30 Jun
RX Application: 77187

Drug Name

GRANISETRON HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML (EQ 1MG BASE/ML)

Approval Date

2008-06-30

77187 / 1

Active Ingredient

GRANISETRON HYDROCHLORIDE

Application Number

77187

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML (EQ 1MG BASE/ML)

Approval Date

2008-06-30

Regulatory Status

RX

2007
31 Dec
Discontinued Application: 77842

Drug Name

GRANISETRON HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2007-12-31

77842 / 1

Active Ingredient

GRANISETRON HYDROCHLORIDE

Application Number

77842

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2007-12-31

Regulatory Status

Discontinued

2008
26 Jun
RX Application: 77913

Drug Name

GRANISETRON HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)

Approval Date

2008-06-26

77913 / 1

Active Ingredient

GRANISETRON HYDROCHLORIDE

Application Number

77913

Product Number

1

Dosage Form

-

Strength

EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)

Approval Date

2008-06-26

Regulatory Status

RX

2009
23 Dec
RX Application: 78629

Drug Name

GRANISETRON HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML (EQ 1MG BASE/ML)

Approval Date

2009-12-23

78629 / 1

Active Ingredient

GRANISETRON HYDROCHLORIDE

Application Number

78629

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML (EQ 1MG BASE/ML)

Approval Date

2009-12-23

Regulatory Status

RX

2009
23 Dec
RX Application: 78629

Drug Name

GRANISETRON HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 4MG BASE/4ML (EQ 1MG BASE/ML)

Approval Date

2009-12-23

78629 / 2

Active Ingredient

GRANISETRON HYDROCHLORIDE

Application Number

78629

Product Number

2

Dosage Form

-

Strength

EQ 4MG BASE/4ML (EQ 1MG BASE/ML)

Approval Date

2009-12-23

Regulatory Status

RX

2001
18 Jun
RX Application: 75858

Drug Name

HALOPERIDOL

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

2001-06-18

75858 / 1

Active Ingredient

HALOPERIDOL LACTATE

Application Number

75858

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

2001-06-18

Regulatory Status

RX

1998
30 Jan
Discontinued Application: 74811

Drug Name

HALOPERIDOL DECANOATE

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/ML

Approval Date

1998-01-30

74811 / 1

Active Ingredient

HALOPERIDOL DECANOATE

Application Number

74811

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/ML

Approval Date

1998-01-30

Regulatory Status

Discontinued

1998
28 Sep
RX Application: 75305

Drug Name

HALOPERIDOL DECANOATE

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE/ML

Approval Date

1998-09-28

75305 / 1

Active Ingredient

HALOPERIDOL DECANOATE

Application Number

75305

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE/ML

Approval Date

1998-09-28

Regulatory Status

RX

1988
12 Apr
Discontinued Application: 72045

Drug Name

HALOPERIDOL INTENSOL

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

1988-04-12

72045 / 1

Active Ingredient

HALOPERIDOL LACTATE

Application Number

72045

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

1988-04-12

Regulatory Status

Discontinued

-
Unclassified Application: 17007

Drug Name

HEPARIN LOCK FLUSH

Product Number

8

Dosage Form

-

Strength

10 UNITS/ML

Approval Date

-

17007 / 8

Active Ingredient

HEPARIN SODIUM

Application Number

17007

Product Number

8

Dosage Form

-

Strength

10 UNITS/ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 17007

Drug Name

HEPARIN LOCK FLUSH

Product Number

9

Dosage Form

-

Strength

100 UNITS/ML

Approval Date

-

17007 / 9

Active Ingredient

HEPARIN SODIUM

Application Number

17007

Product Number

9

Dosage Form

-

Strength

100 UNITS/ML

Approval Date

-

Regulatory Status

Unclassified

1982
01 Jan
Discontinued Application: 17007

Drug Name

HEPARIN SODIUM

Product Number

1

Dosage Form

-

Strength

1,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

17007 / 1

Active Ingredient

HEPARIN SODIUM

Application Number

17007

Product Number

1

Dosage Form

-

Strength

1,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17007

Drug Name

HEPARIN SODIUM

Product Number

2

Dosage Form

-

Strength

5,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

17007 / 2

Active Ingredient

HEPARIN SODIUM

Application Number

17007

Product Number

2

Dosage Form

-

Strength

5,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17007

Drug Name

HEPARIN SODIUM

Product Number

3

Dosage Form

-

Strength

7,500 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

17007 / 3

Active Ingredient

HEPARIN SODIUM

Application Number

17007

Product Number

3

Dosage Form

-

Strength

7,500 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17007

Drug Name

HEPARIN SODIUM

Product Number

4

Dosage Form

-

Strength

10,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

17007 / 4

Active Ingredient

HEPARIN SODIUM

Application Number

17007

Product Number

4

Dosage Form

-

Strength

10,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17007

Drug Name

HEPARIN SODIUM

Product Number

5

Dosage Form

-

Strength

15,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

17007 / 5

Active Ingredient

HEPARIN SODIUM

Application Number

17007

Product Number

5

Dosage Form

-

Strength

15,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17007

Drug Name

HEPARIN SODIUM

Product Number

6

Dosage Form

-

Strength

20,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

17007 / 6

Active Ingredient

HEPARIN SODIUM

Application Number

17007

Product Number

6

Dosage Form

-

Strength

20,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17007

Drug Name

HEPARIN SODIUM

Product Number

7

Dosage Form

-

Strength

2,500 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

17007 / 7

Active Ingredient

HEPARIN SODIUM

Application Number

17007

Product Number

7

Dosage Form

-

Strength

2,500 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17007

Drug Name

HEPARIN SODIUM

Product Number

10

Dosage Form

-

Strength

5,000 UNITS/0.5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

17007 / 10

Active Ingredient

HEPARIN SODIUM

Application Number

17007

Product Number

10

Dosage Form

-

Strength

5,000 UNITS/0.5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
RX Application: 17037

Drug Name

HEPARIN SODIUM

Product Number

1

Dosage Form

-

Strength

1,000 UNITS/ML

Approval Date

1982-01-01

17037 / 1

Active Ingredient

HEPARIN SODIUM

Application Number

17037

Product Number

1

Dosage Form

-

Strength

1,000 UNITS/ML

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 17037

Drug Name

HEPARIN SODIUM

Product Number

2

Dosage Form

-

Strength

5,000 UNITS/ML

Approval Date

1982-01-01

17037 / 2

Active Ingredient

HEPARIN SODIUM

Application Number

17037

Product Number

2

Dosage Form

-

Strength

5,000 UNITS/ML

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 17037

Drug Name

HEPARIN SODIUM

Product Number

3

Dosage Form

-

Strength

10,000 UNITS/ML

Approval Date

1982-01-01

17037 / 3

Active Ingredient

HEPARIN SODIUM

Application Number

17037

Product Number

3

Dosage Form

-

Strength

10,000 UNITS/ML

Approval Date

1982-01-01

Regulatory Status

RX

1986
07 Apr
RX Application: 17037

Drug Name

HEPARIN SODIUM

Product Number

13

Dosage Form

-

Strength

5,000 UNITS/0.5ML

Approval Date

1986-04-07

17037 / 13

Active Ingredient

HEPARIN SODIUM

Application Number

17037

Product Number

13

Dosage Form

-

Strength

5,000 UNITS/0.5ML

Approval Date

1986-04-07

Regulatory Status

RX

2020
18 Dec
RX Application: 213667

Drug Name

HYDRALAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

20MG/ML

Approval Date

2020-12-18

213667 / 1

Active Ingredient

HYDRALAZINE HYDROCHLORIDE

Application Number

213667

Product Number

1

Dosage Form

-

Strength

20MG/ML

Approval Date

2020-12-18

Regulatory Status

RX

2007
26 Nov
Discontinued Application: 77885

Drug Name

HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

2007-11-26

77885 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE

Application Number

77885

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

2007-11-26

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84878

Drug Name

HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

84878 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE

Application Number

84878

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2006
12 Jul
Discontinued Application: 84878

Drug Name

HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2006-07-12

84878 / 2

Active Ingredient

HYDROCHLOROTHIAZIDE

Application Number

84878

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2006-07-12

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83365

Drug Name

HYDROCORTISONE

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

1982-01-01

83365 / 1

Active Ingredient

HYDROCORTISONE

Application Number

83365

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2015
23 Feb
Discontinued Application: 83365

Drug Name

HYDROCORTISONE

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2015-02-23

83365 / 2

Active Ingredient

HYDROCORTISONE

Application Number

83365

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2015-02-23

Regulatory Status

Discontinued

2015
23 Feb
Discontinued Application: 83365

Drug Name

HYDROCORTISONE

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2015-02-23

83365 / 3

Active Ingredient

HYDROCORTISONE

Application Number

83365

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2015-02-23

Regulatory Status

Discontinued

1998
29 Jul
Discontinued Application: 74597

Drug Name

HYDROMORPHONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

8MG

Approval Date

1998-07-29

74597 / 1

Active Ingredient

HYDROMORPHONE HYDROCHLORIDE

Application Number

74597

Product Number

1

Dosage Form

-

Strength

8MG

Approval Date

1998-07-29

Regulatory Status

Discontinued

2009
29 May
Discontinued Application: 74597

Drug Name

HYDROMORPHONE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

4MG

Approval Date

2009-05-29

74597 / 3

Active Ingredient

HYDROMORPHONE HYDROCHLORIDE

Application Number

74597

Product Number

3

Dosage Form

-

Strength

4MG

Approval Date

2009-05-29

Regulatory Status

Discontinued

1998
29 Jul
RX Application: 74653

Drug Name

HYDROMORPHONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG/5ML

Approval Date

1998-07-29

74653 / 1

Active Ingredient

HYDROMORPHONE HYDROCHLORIDE

Application Number

74653

Product Number

1

Dosage Form

-

Strength

5MG/5ML

Approval Date

1998-07-29

Regulatory Status

RX

2018
27 Apr
RX Application: 202159

Drug Name

HYDROMORPHONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

2MG/ML

Approval Date

2018-04-27

202159 / 1

Active Ingredient

HYDROMORPHONE HYDROCHLORIDE

Application Number

202159

Product Number

1

Dosage Form

-

Strength

2MG/ML

Approval Date

2018-04-27

Regulatory Status

RX

2024
09 Feb
RX Application: 216899

Drug Name

HYDROMORPHONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.2MG/ML

Approval Date

2024-02-09

216899 / 1

Active Ingredient

HYDROMORPHONE HYDROCHLORIDE

Application Number

216899

Product Number

1

Dosage Form

-

Strength

0.2MG/ML

Approval Date

2024-02-09

Regulatory Status

RX

2024
09 Feb
RX Application: 216899

Drug Name

HYDROMORPHONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

0.5MG/0.5ML

Approval Date

2024-02-09

216899 / 2

Active Ingredient

HYDROMORPHONE HYDROCHLORIDE

Application Number

216899

Product Number

2

Dosage Form

-

Strength

0.5MG/0.5ML

Approval Date

2024-02-09

Regulatory Status

RX

2024
09 Feb
RX Application: 216899

Drug Name

HYDROMORPHONE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

1MG/ML

Approval Date

2024-02-09

216899 / 3

Active Ingredient

HYDROMORPHONE HYDROCHLORIDE

Application Number

216899

Product Number

3

Dosage Form

-

Strength

1MG/ML

Approval Date

2024-02-09

Regulatory Status

RX

2024
09 Feb
RX Application: 216899

Drug Name

HYDROMORPHONE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

2MG/ML

Approval Date

2024-02-09

216899 / 4

Active Ingredient

HYDROMORPHONE HYDROCHLORIDE

Application Number

216899

Product Number

4

Dosage Form

-

Strength

2MG/ML

Approval Date

2024-02-09

Regulatory Status

RX

2023
14 Dec
RX Application: 217812

Drug Name

HYDROMORPHONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

40MG/20ML (2MG/ML)

Approval Date

2023-12-14

217812 / 1

Active Ingredient

HYDROMORPHONE HYDROCHLORIDE

Application Number

217812

Product Number

1

Dosage Form

-

Strength

40MG/20ML (2MG/ML)

Approval Date

2023-12-14

Regulatory Status

RX

2007
15 Aug
Discontinued Application: 40760

Drug Name

HYDROXYCHLOROQUINE SULFATE

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2007-08-15

40760 / 1

Active Ingredient

HYDROXYCHLOROQUINE SULFATE

Application Number

40760

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2007-08-15

Regulatory Status

Discontinued

1994
28 Oct
Discontinued Application: 40010

Drug Name

HYDROXYZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG/5ML

Approval Date

1994-10-28

40010 / 1

Active Ingredient

HYDROXYZINE HYDROCHLORIDE

Application Number

40010

Product Number

1

Dosage Form

-

Strength

10MG/5ML

Approval Date

1994-10-28

Regulatory Status

Discontinued

2020
21 May
RX Application: 209457

Drug Name

ICOSAPENT ETHYL

Product Number

1

Dosage Form

-

Strength

1GM

Approval Date

2020-05-21

209457 / 1

Active Ingredient

ICOSAPENT ETHYL

Application Number

209457

Product Number

1

Dosage Form

-

Strength

1GM

Approval Date

2020-05-21

Regulatory Status

RX

2023
08 Mar
RX Application: 209457

Drug Name

ICOSAPENT ETHYL

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2023-03-08

209457 / 2

Active Ingredient

ICOSAPENT ETHYL

Application Number

209457

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2023-03-08

Regulatory Status

RX

2006
14 Dec
RX Application: 65275

Drug Name

IDARUBICIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG/5ML (1MG/ML)

Approval Date

2006-12-14

65275 / 1

Active Ingredient

IDARUBICIN HYDROCHLORIDE

Application Number

65275

Product Number

1

Dosage Form

-

Strength

5MG/5ML (1MG/ML)

Approval Date

2006-12-14

Regulatory Status

RX

2006
14 Dec
RX Application: 65275

Drug Name

IDARUBICIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG/10ML (1MG/ML)

Approval Date

2006-12-14

65275 / 2

Active Ingredient

IDARUBICIN HYDROCHLORIDE

Application Number

65275

Product Number

2

Dosage Form

-

Strength

10MG/10ML (1MG/ML)

Approval Date

2006-12-14

Regulatory Status

RX

2006
14 Dec
RX Application: 65275

Drug Name

IDARUBICIN HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

20MG/20ML (1MG/ML)

Approval Date

2006-12-14

65275 / 3

Active Ingredient

IDARUBICIN HYDROCHLORIDE

Application Number

65275

Product Number

3

Dosage Form

-

Strength

20MG/20ML (1MG/ML)

Approval Date

2006-12-14

Regulatory Status

RX

2007
15 May
RX Application: 65288

Drug Name

IDARUBICIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG/5ML (1MG/ML)

Approval Date

2007-05-15

65288 / 1

Active Ingredient

IDARUBICIN HYDROCHLORIDE

Application Number

65288

Product Number

1

Dosage Form

-

Strength

5MG/5ML (1MG/ML)

Approval Date

2007-05-15

Regulatory Status

RX

2007
15 May
RX Application: 65288

Drug Name

IDARUBICIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG/10ML (1MG/ML)

Approval Date

2007-05-15

65288 / 2

Active Ingredient

IDARUBICIN HYDROCHLORIDE

Application Number

65288

Product Number

2

Dosage Form

-

Strength

10MG/10ML (1MG/ML)

Approval Date

2007-05-15

Regulatory Status

RX

2007
15 May
RX Application: 65288

Drug Name

IDARUBICIN HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

20MG/20ML (1MG/ML)

Approval Date

2007-05-15

65288 / 3

Active Ingredient

IDARUBICIN HYDROCHLORIDE

Application Number

65288

Product Number

3

Dosage Form

-

Strength

20MG/20ML (1MG/ML)

Approval Date

2007-05-15

Regulatory Status

RX

2011
29 Jun
RX Application: 76619

Drug Name

IFOSFAMIDE

Product Number

1

Dosage Form

-

Strength

1GM/20ML (50MG/ML)

Approval Date

2011-06-29

76619 / 1

Active Ingredient

IFOSFAMIDE

Application Number

76619

Product Number

1

Dosage Form

-

Strength

1GM/20ML (50MG/ML)

Approval Date

2011-06-29

Regulatory Status

RX

2011
29 Jun
RX Application: 76619

Drug Name

IFOSFAMIDE

Product Number

2

Dosage Form

-

Strength

3GM/60ML (50MG/ML)

Approval Date

2011-06-29

76619 / 2

Active Ingredient

IFOSFAMIDE

Application Number

76619

Product Number

2

Dosage Form

-

Strength

3GM/60ML (50MG/ML)

Approval Date

2011-06-29

Regulatory Status

RX

2018
13 Jul
Discontinued Application: 207586

Drug Name

IMATINIB MESYLATE

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2018-07-13

207586 / 1

Active Ingredient

IMATINIB MESYLATE

Application Number

207586

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2018-07-13

Regulatory Status

Discontinued

2018
13 Jul
Discontinued Application: 207586

Drug Name

IMATINIB MESYLATE

Product Number

2

Dosage Form

-

Strength

EQ 400MG BASE

Approval Date

2018-07-13

207586 / 2

Active Ingredient

IMATINIB MESYLATE

Application Number

207586

Product Number

2

Dosage Form

-

Strength

EQ 400MG BASE

Approval Date

2018-07-13

Regulatory Status

Discontinued

2010
16 Apr
RX Application: 91099

Drug Name

IMIPRAMINE PAMOATE

Product Number

1

Dosage Form

-

Strength

EQ 75MG HYDROCHLORIDE

Approval Date

2010-04-16

91099 / 1

Active Ingredient

IMIPRAMINE PAMOATE

Application Number

91099

Product Number

1

Dosage Form

-

Strength

EQ 75MG HYDROCHLORIDE

Approval Date

2010-04-16

Regulatory Status

RX

2010
16 Apr
RX Application: 91099

Drug Name

IMIPRAMINE PAMOATE

Product Number

2

Dosage Form

-

Strength

EQ 100MG HYDROCHLORIDE

Approval Date

2010-04-16

91099 / 2

Active Ingredient

IMIPRAMINE PAMOATE

Application Number

91099

Product Number

2

Dosage Form

-

Strength

EQ 100MG HYDROCHLORIDE

Approval Date

2010-04-16

Regulatory Status

RX

2010
16 Apr
RX Application: 91099

Drug Name

IMIPRAMINE PAMOATE

Product Number

3

Dosage Form

-

Strength

EQ 125MG HYDROCHLORIDE

Approval Date

2010-04-16

91099 / 3

Active Ingredient

IMIPRAMINE PAMOATE

Application Number

91099

Product Number

3

Dosage Form

-

Strength

EQ 125MG HYDROCHLORIDE

Approval Date

2010-04-16

Regulatory Status

RX

2010
16 Apr
RX Application: 91099

Drug Name

IMIPRAMINE PAMOATE

Product Number

4

Dosage Form

-

Strength

EQ 150MG HYDROCHLORIDE

Approval Date

2010-04-16

91099 / 4

Active Ingredient

IMIPRAMINE PAMOATE

Application Number

91099

Product Number

4

Dosage Form

-

Strength

EQ 150MG HYDROCHLORIDE

Approval Date

2010-04-16

Regulatory Status

RX

2023
09 Mar
RX Application: 203826

Drug Name

IMMPHENTIV

Product Number

4

Dosage Form

-

Strength

0.5MG/5ML (0.1MG/ML)

Approval Date

2023-03-09

203826 / 4

Active Ingredient

PHENYLEPHRINE HYDROCHLORIDE

Application Number

203826

Product Number

4

Dosage Form

-

Strength

0.5MG/5ML (0.1MG/ML)

Approval Date

2023-03-09

Regulatory Status

RX

2023
09 Mar
RX Application: 203826

Drug Name

IMMPHENTIV

Product Number

5

Dosage Form

-

Strength

1MG/10ML (0.1MG/ML)

Approval Date

2023-03-09

203826 / 5

Active Ingredient

PHENYLEPHRINE HYDROCHLORIDE

Application Number

203826

Product Number

5

Dosage Form

-

Strength

1MG/10ML (0.1MG/ML)

Approval Date

2023-03-09

Regulatory Status

RX

1987
18 Mar
Discontinued Application: 71412

Drug Name

INDOMETHACIN

Product Number

1

Dosage Form

-

Strength

25MG/5ML

Approval Date

1987-03-18

71412 / 1

Active Ingredient

INDOMETHACIN

Application Number

71412

Product Number

1

Dosage Form

-

Strength

25MG/5ML

Approval Date

1987-03-18

Regulatory Status

Discontinued

2024
19 Nov
RX Application: 215899

Drug Name

INDOMETHACIN

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2024-11-19

215899 / 1

Active Ingredient

INDOMETHACIN

Application Number

215899

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2024-11-19

Regulatory Status

RX

2008
16 Jul
Discontinued Application: 78713

Drug Name

INDOMETHACIN SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/VIAL

Approval Date

2008-07-16

78713 / 1

Active Ingredient

INDOMETHACIN SODIUM

Application Number

78713

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/VIAL

Approval Date

2008-07-16

Regulatory Status

Discontinued

1991
19 Jul
RX Application: 18565

Drug Name

INFUMORPH

Product Number

3

Dosage Form

-

Strength

10MG/ML

Approval Date

1991-07-19

18565 / 3

Active Ingredient

MORPHINE SULFATE

Application Number

18565

Product Number

3

Dosage Form

-

Strength

10MG/ML

Approval Date

1991-07-19

Regulatory Status

RX

1991
19 Jul
RX Application: 18565

Drug Name

INFUMORPH

Product Number

4

Dosage Form

-

Strength

25MG/ML

Approval Date

1991-07-19

18565 / 4

Active Ingredient

MORPHINE SULFATE

Application Number

18565

Product Number

4

Dosage Form

-

Strength

25MG/ML

Approval Date

1991-07-19

Regulatory Status

RX

2003
05 Nov
RX Application: 76598

Drug Name

IPRATROPIUM BROMIDE

Product Number

1

Dosage Form

-

Strength

0.042MG/SPRAY

Approval Date

2003-11-05

76598 / 1

Active Ingredient

IPRATROPIUM BROMIDE

Application Number

76598

Product Number

1

Dosage Form

-

Strength

0.042MG/SPRAY

Approval Date

2003-11-05

Regulatory Status

RX

2003
05 Nov
RX Application: 76664

Drug Name

IPRATROPIUM BROMIDE

Product Number

1

Dosage Form

-

Strength

0.021MG/SPRAY

Approval Date

2003-11-05

76664 / 1

Active Ingredient

IPRATROPIUM BROMIDE

Application Number

76664

Product Number

1

Dosage Form

-

Strength

0.021MG/SPRAY

Approval Date

2003-11-05

Regulatory Status

RX

2012
15 Oct
Discontinued Application: 90201

Drug Name

IRBESARTAN

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

2012-10-15

90201 / 1

Active Ingredient

IRBESARTAN

Application Number

90201

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

2012-10-15

Regulatory Status

Discontinued

2012
15 Oct
Discontinued Application: 90201

Drug Name

IRBESARTAN

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

2012-10-15

90201 / 2

Active Ingredient

IRBESARTAN

Application Number

90201

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

2012-10-15

Regulatory Status

Discontinued

2012
15 Oct
Discontinued Application: 90201

Drug Name

IRBESARTAN

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

2012-10-15

90201 / 3

Active Ingredient

IRBESARTAN

Application Number

90201

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

2012-10-15

Regulatory Status

Discontinued

2012
15 Oct
Discontinued Application: 90351

Drug Name

IRBESARTAN AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

12.5MG;150MG

Approval Date

2012-10-15

90351 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; IRBESARTAN

Application Number

90351

Product Number

1

Dosage Form

-

Strength

12.5MG;150MG

Approval Date

2012-10-15

Regulatory Status

Discontinued

2012
15 Oct
Discontinued Application: 90351

Drug Name

IRBESARTAN AND HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

12.5MG;300MG

Approval Date

2012-10-15

90351 / 2

Active Ingredient

HYDROCHLOROTHIAZIDE; IRBESARTAN

Application Number

90351

Product Number

2

Dosage Form

-

Strength

12.5MG;300MG

Approval Date

2012-10-15

Regulatory Status

Discontinued

2017
08 Jun
Discontinued Application: 90351

Drug Name

IRBESARTAN AND HYDROCHLOROTHIAZIDE

Product Number

3

Dosage Form

-

Strength

25MG;300MG

Approval Date

2017-06-08

90351 / 3

Active Ingredient

HYDROCHLOROTHIAZIDE; IRBESARTAN

Application Number

90351

Product Number

3

Dosage Form

-

Strength

25MG;300MG

Approval Date

2017-06-08

Regulatory Status

Discontinued

2008
24 Dec
RX Application: 78753

Drug Name

IRINOTECAN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

40MG/2ML (20MG/ML)

Approval Date

2008-12-24

78753 / 1

Active Ingredient

IRINOTECAN HYDROCHLORIDE

Application Number

78753

Product Number

1

Dosage Form

-

Strength

40MG/2ML (20MG/ML)

Approval Date

2008-12-24

Regulatory Status

RX

2008
24 Dec
RX Application: 78753

Drug Name

IRINOTECAN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

100MG/5ML (20MG/ML)

Approval Date

2008-12-24

78753 / 2

Active Ingredient

IRINOTECAN HYDROCHLORIDE

Application Number

78753

Product Number

2

Dosage Form

-

Strength

100MG/5ML (20MG/ML)

Approval Date

2008-12-24

Regulatory Status

RX

2010
20 Dec
RX Application: 91032

Drug Name

IRINOTECAN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

40MG/2ML (20MG/ML)

Approval Date

2010-12-20

91032 / 1

Active Ingredient

IRINOTECAN HYDROCHLORIDE

Application Number

91032

Product Number

1

Dosage Form

-

Strength

40MG/2ML (20MG/ML)

Approval Date

2010-12-20

Regulatory Status

RX

2010
20 Dec
RX Application: 91032

Drug Name

IRINOTECAN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

100MG/5ML (20MG/ML)

Approval Date

2010-12-20

91032 / 2

Active Ingredient

IRINOTECAN HYDROCHLORIDE

Application Number

91032

Product Number

2

Dosage Form

-

Strength

100MG/5ML (20MG/ML)

Approval Date

2010-12-20

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 80212

Drug Name

ISONIAZID

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

80212 / 1

Active Ingredient

ISONIAZID

Application Number

80212

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 80212

Drug Name

ISONIAZID

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

1982-01-01

80212 / 2

Active Ingredient

ISONIAZID

Application Number

80212

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

-
Unclassified Application: 87425

Drug Name

ISONIAZID

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

-

87425 / 1

Active Ingredient

ISONIAZID

Application Number

87425

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

-

Regulatory Status

Unclassified

2023
26 Apr
RX Application: 211703

Drug Name

ISOPROTERENOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.2MG/ML

Approval Date

2023-04-26

211703 / 1

Active Ingredient

ISOPROTERENOL HYDROCHLORIDE

Application Number

211703

Product Number

1

Dosage Form

-

Strength

0.2MG/ML

Approval Date

2023-04-26

Regulatory Status

RX

2007
10 Jan
Discontinued Application: 40591

Drug Name

ISOSORBIDE DINITRATE

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

2007-01-10

40591 / 1

Active Ingredient

ISOSORBIDE DINITRATE

Application Number

40591

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

2007-01-10

Regulatory Status

Discontinued

1987
02 Nov
Discontinued Application: 86055

Drug Name

ISOSORBIDE DINITRATE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1987-11-02

86055 / 1

Active Ingredient

ISOSORBIDE DINITRATE

Application Number

86055

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1987-11-02

Regulatory Status

Discontinued

1987
29 Oct
Discontinued Application: 86055

Drug Name

ISOSORBIDE DINITRATE

Product Number

2

Dosage Form

-

Strength

2.5MG

Approval Date

1987-10-29

86055 / 2

Active Ingredient

ISOSORBIDE DINITRATE

Application Number

86055

Product Number

2

Dosage Form

-

Strength

2.5MG

Approval Date

1987-10-29

Regulatory Status

Discontinued

1987
02 Nov
RX Application: 88088

Drug Name

ISOSORBIDE DINITRATE

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

1987-11-02

88088 / 1

Active Ingredient

ISOSORBIDE DINITRATE

Application Number

88088

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

1987-11-02

Regulatory Status

RX

1987
29 Oct
RX Application: 88088

Drug Name

ISOSORBIDE DINITRATE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

1987-10-29

88088 / 2

Active Ingredient

ISOSORBIDE DINITRATE

Application Number

88088

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

1987-10-29

Regulatory Status

RX

1987
29 Oct
RX Application: 88088

Drug Name

ISOSORBIDE DINITRATE

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

1987-10-29

88088 / 3

Active Ingredient

ISOSORBIDE DINITRATE

Application Number

88088

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

1987-10-29

Regulatory Status

RX

2000
05 Oct
Discontinued Application: 75361

Drug Name

ISOSORBIDE MONONITRATE

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2000-10-05

75361 / 1

Active Ingredient

ISOSORBIDE MONONITRATE

Application Number

75361

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2000-10-05

Regulatory Status

Discontinued

2005
07 Jan
Discontinued Application: 76813

Drug Name

ISOSORBIDE MONONITRATE

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

2005-01-07

76813 / 1

Active Ingredient

ISOSORBIDE MONONITRATE

Application Number

76813

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

2005-01-07

Regulatory Status

Discontinued

2006
30 Mar
Discontinued Application: 76813

Drug Name

ISOSORBIDE MONONITRATE

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2006-03-30

76813 / 2

Active Ingredient

ISOSORBIDE MONONITRATE

Application Number

76813

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2006-03-30

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 62324

Drug Name

KANAMYCIN

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE/2ML

Approval Date

1982-01-01

62324 / 1

Active Ingredient

KANAMYCIN SULFATE

Application Number

62324

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE/2ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 62324

Drug Name

KANAMYCIN

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/2ML

Approval Date

1982-01-01

62324 / 2

Active Ingredient

KANAMYCIN SULFATE

Application Number

62324

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/2ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 62324

Drug Name

KANAMYCIN

Product Number

3

Dosage Form

-

Strength

EQ 1GM BASE/3ML

Approval Date

1982-01-01

62324 / 3

Active Ingredient

KANAMYCIN SULFATE

Application Number

62324

Product Number

3

Dosage Form

-

Strength

EQ 1GM BASE/3ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1996
22 Mar
RX Application: 74524

Drug Name

KETAMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/ML

Approval Date

1996-03-22

74524 / 1

Active Ingredient

KETAMINE HYDROCHLORIDE

Application Number

74524

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/ML

Approval Date

1996-03-22

Regulatory Status

RX

1996
22 Mar
RX Application: 74524

Drug Name

KETAMINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE/ML

Approval Date

1996-03-22

74524 / 2

Active Ingredient

KETAMINE HYDROCHLORIDE

Application Number

74524

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE/ML

Approval Date

1996-03-22

Regulatory Status

RX

1999
26 Apr
Discontinued Application: 75222

Drug Name

KETOROLAC TROMETHAMINE

Product Number

1

Dosage Form

-

Strength

15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1999-04-26

75222 / 1

Active Ingredient

KETOROLAC TROMETHAMINE

Application Number

75222

Product Number

1

Dosage Form

-

Strength

15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1999-04-26

Regulatory Status

Discontinued

1999
26 Apr
Discontinued Application: 75222

Drug Name

KETOROLAC TROMETHAMINE

Product Number

2

Dosage Form

-

Strength

30MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1999-04-26

75222 / 2

Active Ingredient

KETOROLAC TROMETHAMINE

Application Number

75222

Product Number

2

Dosage Form

-

Strength

30MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1999-04-26

Regulatory Status

Discontinued

1999
26 Apr
Discontinued Application: 75228

Drug Name

KETOROLAC TROMETHAMINE

Product Number

1

Dosage Form

-

Strength

30MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1999-04-26

75228 / 1

Active Ingredient

KETOROLAC TROMETHAMINE

Application Number

75228

Product Number

1

Dosage Form

-

Strength

30MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1999-04-26

Regulatory Status

Discontinued

1999
03 Nov
Discontinued Application: 75299

Drug Name

KETOROLAC TROMETHAMINE

Product Number

1

Dosage Form

-

Strength

15MG/ML

Approval Date

1999-11-03

75299 / 1

Active Ingredient

KETOROLAC TROMETHAMINE

Application Number

75299

Product Number

1

Dosage Form

-

Strength

15MG/ML

Approval Date

1999-11-03

Regulatory Status

Discontinued

1999
03 Nov
Discontinued Application: 75299

Drug Name

KETOROLAC TROMETHAMINE

Product Number

2

Dosage Form

-

Strength

30MG/ML

Approval Date

1999-11-03

75299 / 2

Active Ingredient

KETOROLAC TROMETHAMINE

Application Number

75299

Product Number

2

Dosage Form

-

Strength

30MG/ML

Approval Date

1999-11-03

Regulatory Status

Discontinued

2004
21 Jul
RX Application: 75772

Drug Name

KETOROLAC TROMETHAMINE

Product Number

1

Dosage Form

-

Strength

15MG/ML

Approval Date

2004-07-21

75772 / 1

Active Ingredient

KETOROLAC TROMETHAMINE

Application Number

75772

Product Number

1

Dosage Form

-

Strength

15MG/ML

Approval Date

2004-07-21

Regulatory Status

RX

2004
21 Jul
RX Application: 75772

Drug Name

KETOROLAC TROMETHAMINE

Product Number

2

Dosage Form

-

Strength

30MG/ML

Approval Date

2004-07-21

75772 / 2

Active Ingredient

KETOROLAC TROMETHAMINE

Application Number

75772

Product Number

2

Dosage Form

-

Strength

30MG/ML

Approval Date

2004-07-21

Regulatory Status

RX

-
Unclassified Application: 75772

Drug Name

KETOROLAC TROMETHAMINE

Product Number

3

Dosage Form

-

Strength

60MG/2ML

Approval Date

-

75772 / 3

Active Ingredient

KETOROLAC TROMETHAMINE

Application Number

75772

Product Number

3

Dosage Form

-

Strength

60MG/2ML

Approval Date

-

Regulatory Status

Unclassified

2021
29 Apr
RX Application: 212045

Drug Name

KLOXXADO

Product Number

1

Dosage Form

-

Strength

8MG/SPRAY

Approval Date

2021-04-29

212045 / 1

Active Ingredient

NALOXONE HYDROCHLORIDE

Application Number

212045

Product Number

1

Dosage Form

-

Strength

8MG/SPRAY

Approval Date

2021-04-29

Regulatory Status

RX

2025
25 Aug
RX Application: 212045

Drug Name

KLOXXADO

Product Number

2

Dosage Form

-

Strength

4MG/SPRAY

Approval Date

2025-08-25

212045 / 2

Active Ingredient

NALOXONE HYDROCHLORIDE

Application Number

212045

Product Number

2

Dosage Form

-

Strength

4MG/SPRAY

Approval Date

2025-08-25

Regulatory Status

RX

1999
28 May
RX Application: 75303

Drug Name

LABETALOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG/ML

Approval Date

1999-05-28

75303 / 1

Active Ingredient

LABETALOL HYDROCHLORIDE

Application Number

75303

Product Number

1

Dosage Form

-

Strength

5MG/ML

Approval Date

1999-05-28

Regulatory Status

RX

2022
18 Mar
Discontinued Application: 213330

Drug Name

LABETALOL HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

10MG/2ML (5MG/ML)

Approval Date

2022-03-18

213330 / 5

Active Ingredient

LABETALOL HYDROCHLORIDE

Application Number

213330

Product Number

5

Dosage Form

-

Strength

10MG/2ML (5MG/ML)

Approval Date

2022-03-18

Regulatory Status

Discontinued

2024
19 Aug
RX Application: 213330

Drug Name

LABETALOL HYDROCHLORIDE

Product Number

6

Dosage Form

-

Strength

20MG/4ML (5MG/ML)

Approval Date

2024-08-19

213330 / 6

Active Ingredient

LABETALOL HYDROCHLORIDE

Application Number

213330

Product Number

6

Dosage Form

-

Strength

20MG/4ML (5MG/ML)

Approval Date

2024-08-19

Regulatory Status

RX

2020
09 Nov
RX Application: 213330

Drug Name

LABETALOL HYDROCHLORIDE IN DEXTROSE

Product Number

1

Dosage Form

-

Strength

200MG/200ML (1MG/ML)

Approval Date

2020-11-09

213330 / 1

Active Ingredient

LABETALOL HYDROCHLORIDE

Application Number

213330

Product Number

1

Dosage Form

-

Strength

200MG/200ML (1MG/ML)

Approval Date

2020-11-09

Regulatory Status

RX

2020
09 Nov
RX Application: 213330

Drug Name

LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE

Product Number

2

Dosage Form

-

Strength

100MG/100ML (1MG/ML)

Approval Date

2020-11-09

213330 / 2

Active Ingredient

LABETALOL HYDROCHLORIDE

Application Number

213330

Product Number

2

Dosage Form

-

Strength

100MG/100ML (1MG/ML)

Approval Date

2020-11-09

Regulatory Status

RX

2020
09 Nov
RX Application: 213330

Drug Name

LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE

Product Number

3

Dosage Form

-

Strength

200MG/200ML (1MG/ML)

Approval Date

2020-11-09

213330 / 3

Active Ingredient

LABETALOL HYDROCHLORIDE

Application Number

213330

Product Number

3

Dosage Form

-

Strength

200MG/200ML (1MG/ML)

Approval Date

2020-11-09

Regulatory Status

RX

2020
09 Nov
RX Application: 213330

Drug Name

LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE

Product Number

4

Dosage Form

-

Strength

300MG/300ML (1MG/ML)

Approval Date

2020-11-09

213330 / 4

Active Ingredient

LABETALOL HYDROCHLORIDE

Application Number

213330

Product Number

4

Dosage Form

-

Strength

300MG/300ML (1MG/ML)

Approval Date

2020-11-09

Regulatory Status

RX

2024
05 Apr
RX Application: 216806

Drug Name

LACOSAMIDE

Product Number

1

Dosage Form

-

Strength

200MG/20ML (10MG/ML)

Approval Date

2024-04-05

216806 / 1

Active Ingredient

LACOSAMIDE

Application Number

216806

Product Number

1

Dosage Form

-

Strength

200MG/20ML (10MG/ML)

Approval Date

2024-04-05

Regulatory Status

RX

1992
29 May
Discontinued Application: 73591

Drug Name

LACTULOSE

Product Number

1

Dosage Form

-

Strength

10GM/15ML

Approval Date

1992-05-29

73591 / 1

Active Ingredient

LACTULOSE

Application Number

73591

Product Number

1

Dosage Form

-

Strength

10GM/15ML

Approval Date

1992-05-29

Regulatory Status

Discontinued

1995
03 Jul
Discontinued Application: 74076

Drug Name

LACTULOSE

Product Number

1

Dosage Form

-

Strength

10GM/15ML

Approval Date

1995-07-03

74076 / 1

Active Ingredient

LACTULOSE

Application Number

74076

Product Number

1

Dosage Form

-

Strength

10GM/15ML

Approval Date

1995-07-03

Regulatory Status

Discontinued

2011
19 Apr
Discontinued Application: 78134

Drug Name

LAMOTRIGINE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2011-04-19

78134 / 1

Active Ingredient

LAMOTRIGINE

Application Number

78134

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2011-04-19

Regulatory Status

Discontinued

2011
19 Apr
Discontinued Application: 78134

Drug Name

LAMOTRIGINE

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2011-04-19

78134 / 2

Active Ingredient

LAMOTRIGINE

Application Number

78134

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2011-04-19

Regulatory Status

Discontinued

2011
19 Apr
Discontinued Application: 78134

Drug Name

LAMOTRIGINE

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2011-04-19

78134 / 3

Active Ingredient

LAMOTRIGINE

Application Number

78134

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2011-04-19

Regulatory Status

Discontinued

2011
19 Apr
Discontinued Application: 78134

Drug Name

LAMOTRIGINE

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2011-04-19

78134 / 4

Active Ingredient

LAMOTRIGINE

Application Number

78134

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2011-04-19

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 12382

Drug Name

LARGON

Product Number

2

Dosage Form

-

Strength

20MG/ML

Approval Date

1982-01-01

12382 / 2

Active Ingredient

PROPIOMAZINE HYDROCHLORIDE

Application Number

12382

Product Number

2

Dosage Form

-

Strength

20MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

2011
03 Jun
Discontinued Application: 90838

Drug Name

LETROZOLE

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2011-06-03

90838 / 1

Active Ingredient

LETROZOLE

Application Number

90838

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2011-06-03

Regulatory Status

Discontinued

2016
03 Jun
Discontinued Application: 203796

Drug Name

LETROZOLE

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2016-06-03

203796 / 1

Active Ingredient

LETROZOLE

Application Number

203796

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2016-06-03

Regulatory Status

Discontinued

1993
22 Feb
RX Application: 72733

Drug Name

LEUCOVORIN CALCIUM

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

1993-02-22

72733 / 1

Active Ingredient

LEUCOVORIN CALCIUM

Application Number

72733

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

1993-02-22

Regulatory Status

RX

1993
22 Feb
RX Application: 72734

Drug Name

LEUCOVORIN CALCIUM

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

1993-02-22

72734 / 1

Active Ingredient

LEUCOVORIN CALCIUM

Application Number

72734

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

1993-02-22

Regulatory Status

RX

1993
22 Feb
RX Application: 72735

Drug Name

LEUCOVORIN CALCIUM

Product Number

1

Dosage Form

-

Strength

EQ 15MG BASE

Approval Date

1993-02-22

72735 / 1

Active Ingredient

LEUCOVORIN CALCIUM

Application Number

72735

Product Number

1

Dosage Form

-

Strength

EQ 15MG BASE

Approval Date

1993-02-22

Regulatory Status

RX

1993
22 Feb
RX Application: 72736

Drug Name

LEUCOVORIN CALCIUM

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

1993-02-22

72736 / 1

Active Ingredient

LEUCOVORIN CALCIUM

Application Number

72736

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

1993-02-22

Regulatory Status

RX

1987
14 Sep
RX Application: 89384

Drug Name

LEUCOVORIN CALCIUM

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/VIAL

Approval Date

1987-09-14

89384 / 1

Active Ingredient

LEUCOVORIN CALCIUM

Application Number

89384

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/VIAL

Approval Date

1987-09-14

Regulatory Status

RX

1988
28 Mar
RX Application: 89717

Drug Name

LEUCOVORIN CALCIUM

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE/VIAL

Approval Date

1988-03-28

89717 / 1

Active Ingredient

LEUCOVORIN CALCIUM

Application Number

89717

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE/VIAL

Approval Date

1988-03-28

Regulatory Status

RX

1995
23 May
RX Application: 40056

Drug Name

LEUCOVORIN CALCIUM PRESERVATIVE FREE

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE/VIAL

Approval Date

1995-05-23

40056 / 1

Active Ingredient

LEUCOVORIN CALCIUM

Application Number

40056

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE/VIAL

Approval Date

1995-05-23

Regulatory Status

RX

2000
20 Apr
RX Application: 40335

Drug Name

LEUCOVORIN CALCIUM PRESERVATIVE FREE

Product Number

1

Dosage Form

-

Strength

EQ 350MG BASE/VIAL

Approval Date

2000-04-20

40335 / 1

Active Ingredient

LEUCOVORIN CALCIUM

Application Number

40335

Product Number

1

Dosage Form

-

Strength

EQ 350MG BASE/VIAL

Approval Date

2000-04-20

Regulatory Status

RX

2000
25 Apr
Discontinued Application: 40347

Drug Name

LEUCOVORIN CALCIUM PRESERVATIVE FREE

Product Number

1

Dosage Form

-

Strength

EQ 300MG BASE/30ML (EQ 10MG BASE/ML)

Approval Date

2000-04-25

40347 / 1

Active Ingredient

LEUCOVORIN CALCIUM

Application Number

40347

Product Number

1

Dosage Form

-

Strength

EQ 300MG BASE/30ML (EQ 10MG BASE/ML)

Approval Date

2000-04-25

Regulatory Status

Discontinued

2000
25 Apr
Discontinued Application: 40347

Drug Name

LEUCOVORIN CALCIUM PRESERVATIVE FREE

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/50ML (EQ 10MG BASE/ML)

Approval Date

2000-04-25

40347 / 2

Active Ingredient

LEUCOVORIN CALCIUM

Application Number

40347

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/50ML (EQ 10MG BASE/ML)

Approval Date

2000-04-25

Regulatory Status

Discontinued

2012
28 Feb
Discontinued Application: 90601

Drug Name

LEVETIRACETAM

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2012-02-28

90601 / 1

Active Ingredient

LEVETIRACETAM

Application Number

90601

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2012-02-28

Regulatory Status

Discontinued

2011
13 Oct
RX Application: 90981

Drug Name

LEVETIRACETAM

Product Number

1

Dosage Form

-

Strength

500MG/5ML (100MG/ML)

Approval Date

2011-10-13

90981 / 1

Active Ingredient

LEVETIRACETAM

Application Number

90981

Product Number

1

Dosage Form

-

Strength

500MG/5ML (100MG/ML)

Approval Date

2011-10-13

Regulatory Status

RX

2024
12 Feb
RX Application: 211356

Drug Name

LEVETIRACETAM IN SODIUM CHLORIDE

Product Number

1

Dosage Form

-

Strength

500MG/100ML (5MG/ML)

Approval Date

2024-02-12

211356 / 1

Active Ingredient

LEVETIRACETAM

Application Number

211356

Product Number

1

Dosage Form

-

Strength

500MG/100ML (5MG/ML)

Approval Date

2024-02-12

Regulatory Status

RX

2024
12 Feb
RX Application: 211356

Drug Name

LEVETIRACETAM IN SODIUM CHLORIDE

Product Number

2

Dosage Form

-

Strength

1GM/100ML (10MG/ML)

Approval Date

2024-02-12

211356 / 2

Active Ingredient

LEVETIRACETAM

Application Number

211356

Product Number

2

Dosage Form

-

Strength

1GM/100ML (10MG/ML)

Approval Date

2024-02-12

Regulatory Status

RX

2024
12 Feb
RX Application: 211356

Drug Name

LEVETIRACETAM IN SODIUM CHLORIDE

Product Number

3

Dosage Form

-

Strength

1.5GM/100ML (15MG/ML)

Approval Date

2024-02-12

211356 / 3

Active Ingredient

LEVETIRACETAM

Application Number

211356

Product Number

3

Dosage Form

-

Strength

1.5GM/100ML (15MG/ML)

Approval Date

2024-02-12

Regulatory Status

RX

2001
29 Mar
RX Application: 75567

Drug Name

LEVOCARNITINE

Product Number

1

Dosage Form

-

Strength

200MG/ML

Approval Date

2001-03-29

75567 / 1

Active Ingredient

LEVOCARNITINE

Application Number

75567

Product Number

1

Dosage Form

-

Strength

200MG/ML

Approval Date

2001-03-29

Regulatory Status

RX

2007
25 Oct
Discontinued Application: 77399

Drug Name

LEVOCARNITINE

Product Number

1

Dosage Form

-

Strength

1GM/10ML

Approval Date

2007-10-25

77399 / 1

Active Ingredient

LEVOCARNITINE

Application Number

77399

Product Number

1

Dosage Form

-

Strength

1GM/10ML

Approval Date

2007-10-25

Regulatory Status

Discontinued

-
Unclassified Application: 78767

Drug Name

LEVOFLOXACIN

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

-

78767 / 1

Active Ingredient

LEVOFLOXACIN

Application Number

78767

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 78767

Drug Name

LEVOFLOXACIN

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

-

78767 / 2

Active Ingredient

LEVOFLOXACIN

Application Number

78767

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 78767

Drug Name

LEVOFLOXACIN

Product Number

3

Dosage Form

-

Strength

750MG

Approval Date

-

78767 / 3

Active Ingredient

LEVOFLOXACIN

Application Number

78767

Product Number

3

Dosage Form

-

Strength

750MG

Approval Date

-

Regulatory Status

Unclassified

2011
16 Sep
RX Application: 91375

Drug Name

LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

EQ 250MG/50ML (EQ 5MG/ML)

Approval Date

2011-09-16

91375 / 1

Active Ingredient

LEVOFLOXACIN

Application Number

91375

Product Number

1

Dosage Form

-

Strength

EQ 250MG/50ML (EQ 5MG/ML)

Approval Date

2011-09-16

Regulatory Status

RX

2011
16 Sep
RX Application: 91375

Drug Name

LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

EQ 500MG/100ML (EQ 5MG/ML)

Approval Date

2011-09-16

91375 / 2

Active Ingredient

LEVOFLOXACIN

Application Number

91375

Product Number

2

Dosage Form

-

Strength

EQ 500MG/100ML (EQ 5MG/ML)

Approval Date

2011-09-16

Regulatory Status

RX

2011
16 Sep
RX Application: 91375

Drug Name

LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

3

Dosage Form

-

Strength

EQ 750MG/150ML (EQ 5MG/ML)

Approval Date

2011-09-16

91375 / 3

Active Ingredient

LEVOFLOXACIN

Application Number

91375

Product Number

3

Dosage Form

-

Strength

EQ 750MG/150ML (EQ 5MG/ML)

Approval Date

2011-09-16

Regulatory Status

RX

2016
16 Jun
Discontinued Application: 206263

Drug Name

LEVOLEUCOVORIN CALCIUM

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/VIAL

Approval Date

2016-06-16

206263 / 1

Active Ingredient

LEVOLEUCOVORIN CALCIUM

Application Number

206263

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/VIAL

Approval Date

2016-06-16

Regulatory Status

Discontinued

2020
05 Nov
Discontinued Application: 210732

Drug Name

LEVOMILNACIPRAN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2020-11-05

210732 / 1

Active Ingredient

LEVOMILNACIPRAN HYDROCHLORIDE

Application Number

210732

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2020-11-05

Regulatory Status

Discontinued

2020
05 Nov
Discontinued Application: 210732

Drug Name

LEVOMILNACIPRAN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2020-11-05

210732 / 2

Active Ingredient

LEVOMILNACIPRAN HYDROCHLORIDE

Application Number

210732

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2020-11-05

Regulatory Status

Discontinued

2020
05 Nov
Discontinued Application: 210732

Drug Name

LEVOMILNACIPRAN HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 80MG BASE

Approval Date

2020-11-05

210732 / 3

Active Ingredient

LEVOMILNACIPRAN HYDROCHLORIDE

Application Number

210732

Product Number

3

Dosage Form

-

Strength

EQ 80MG BASE

Approval Date

2020-11-05

Regulatory Status

Discontinued

2020
05 Nov
Discontinued Application: 210732

Drug Name

LEVOMILNACIPRAN HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 120MG BASE

Approval Date

2020-11-05

210732 / 4

Active Ingredient

LEVOMILNACIPRAN HYDROCHLORIDE

Application Number

210732

Product Number

4

Dosage Form

-

Strength

EQ 120MG BASE

Approval Date

2020-11-05

Regulatory Status

Discontinued

2000
31 Mar
RX Application: 74278

Drug Name

LEVORPHANOL TARTRATE

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2000-03-31

74278 / 1

Active Ingredient

LEVORPHANOL TARTRATE

Application Number

74278

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2000-03-31

Regulatory Status

RX

2018
18 Jun
Discontinued Application: 74278

Drug Name

LEVORPHANOL TARTRATE

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

2018-06-18

74278 / 2

Active Ingredient

LEVORPHANOL TARTRATE

Application Number

74278

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

2018-06-18

Regulatory Status

Discontinued

2018
18 Jun
Discontinued Application: 74278

Drug Name

LEVORPHANOL TARTRATE

Product Number

3

Dosage Form

-

Strength

3MG

Approval Date

2018-06-18

74278 / 3

Active Ingredient

LEVORPHANOL TARTRATE

Application Number

74278

Product Number

3

Dosage Form

-

Strength

3MG

Approval Date

2018-06-18

Regulatory Status

Discontinued

2021
17 May
RX Application: 214253

Drug Name

LEVOTHYROXINE SODIUM

Product Number

1

Dosage Form

-

Strength

100MCG/ML

Approval Date

2021-05-17

214253 / 1

Active Ingredient

LEVOTHYROXINE SODIUM

Application Number

214253

Product Number

1

Dosage Form

-

Strength

100MCG/ML

Approval Date

2021-05-17

Regulatory Status

RX

2003
25 Sep
Discontinued Application: 76290

Drug Name

LIDOCAINE AND PRILOCAINE

Product Number

1

Dosage Form

-

Strength

2.5%;2.5%

Approval Date

2003-09-25

76290 / 1

Active Ingredient

LIDOCAINE; PRILOCAINE

Application Number

76290

Product Number

1

Dosage Form

-

Strength

2.5%;2.5%

Approval Date

2003-09-25

Regulatory Status

Discontinued

1995
10 Jul
Discontinued Application: 40014

Drug Name

LIDOCAINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1995-07-10

40014 / 1

Active Ingredient

LIDOCAINE HYDROCHLORIDE

Application Number

40014

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1995-07-10

Regulatory Status

Discontinued

1985
03 Apr
RX Application: 88803

Drug Name

LIDOCAINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

4%

Approval Date

1985-04-03

88803 / 1

Active Ingredient

LIDOCAINE HYDROCHLORIDE

Application Number

88803

Product Number

1

Dosage Form

-

Strength

4%

Approval Date

1985-04-03

Regulatory Status

RX

1982
01 Jan
RX Application: 84625

Drug Name

LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1982-01-01

84625 / 1

Active Ingredient

LIDOCAINE HYDROCHLORIDE

Application Number

84625

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 84625

Drug Name

LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE

Product Number

2

Dosage Form

-

Strength

2%

Approval Date

1982-01-01

84625 / 2

Active Ingredient

LIDOCAINE HYDROCHLORIDE

Application Number

84625

Product Number

2

Dosage Form

-

Strength

2%

Approval Date

1982-01-01

Regulatory Status

RX

1985
26 Apr
RX Application: 88802

Drug Name

LIDOCAINE VISCOUS

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1985-04-26

88802 / 1

Active Ingredient

LIDOCAINE HYDROCHLORIDE

Application Number

88802

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1985-04-26

Regulatory Status

RX

2015
03 Jun
RX Application: 200068

Drug Name

LINEZOLID

Product Number

1

Dosage Form

-

Strength

100MG/5ML

Approval Date

2015-06-03

200068 / 1

Active Ingredient

LINEZOLID

Application Number

200068

Product Number

1

Dosage Form

-

Strength

100MG/5ML

Approval Date

2015-06-03

Regulatory Status

RX

2022
22 Aug
RX Application: 206454

Drug Name

LINEZOLID

Product Number

1

Dosage Form

-

Strength

600MG/300ML (2MG/ML)

Approval Date

2022-08-22

206454 / 1

Active Ingredient

LINEZOLID

Application Number

206454

Product Number

1

Dosage Form

-

Strength

600MG/300ML (2MG/ML)

Approval Date

2022-08-22

Regulatory Status

RX

2024
23 Dec
RX Application: 215503

Drug Name

LIRAGLUTIDE

Product Number

1

Dosage Form

-

Strength

18MG/3ML (6MG/ML)

Approval Date

2024-12-23

215503 / 1

Active Ingredient

LIRAGLUTIDE

Application Number

215503

Product Number

1

Dosage Form

-

Strength

18MG/3ML (6MG/ML)

Approval Date

2024-12-23

Regulatory Status

RX

2023
25 Aug
RX Application: 202827

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2023-08-25

202827 / 1

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

202827

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2023-08-25

Regulatory Status

RX

2023
25 Aug
RX Application: 202827

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2023-08-25

202827 / 2

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

202827

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2023-08-25

Regulatory Status

RX

2023
25 Aug
RX Application: 202827

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2023-08-25

202827 / 3

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

202827

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2023-08-25

Regulatory Status

RX

2023
25 Aug
RX Application: 202827

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

4

Dosage Form

-

Strength

50MG

Approval Date

2023-08-25

202827 / 4

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

202827

Product Number

4

Dosage Form

-

Strength

50MG

Approval Date

2023-08-25

Regulatory Status

RX

2023
25 Aug
RX Application: 202827

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

5

Dosage Form

-

Strength

60MG

Approval Date

2023-08-25

202827 / 5

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

202827

Product Number

5

Dosage Form

-

Strength

60MG

Approval Date

2023-08-25

Regulatory Status

RX

2023
25 Aug
RX Application: 202827

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

6

Dosage Form

-

Strength

70MG

Approval Date

2023-08-25

202827 / 6

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

202827

Product Number

6

Dosage Form

-

Strength

70MG

Approval Date

2023-08-25

Regulatory Status

RX

2024
17 Jan
RX Application: 202827

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

7

Dosage Form

-

Strength

10MG

Approval Date

2024-01-17

202827 / 7

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

202827

Product Number

7

Dosage Form

-

Strength

10MG

Approval Date

2024-01-17

Regulatory Status

RX

2002
01 Jul
Discontinued Application: 76063

Drug Name

LISINOPRIL

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2002-07-01

76063 / 1

Active Ingredient

LISINOPRIL

Application Number

76063

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2002-07-01

Regulatory Status

Discontinued

2002
01 Jul
Discontinued Application: 76063

Drug Name

LISINOPRIL

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2002-07-01

76063 / 2

Active Ingredient

LISINOPRIL

Application Number

76063

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2002-07-01

Regulatory Status

Discontinued

2002
01 Jul
Discontinued Application: 76063

Drug Name

LISINOPRIL

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2002-07-01

76063 / 3

Active Ingredient

LISINOPRIL

Application Number

76063

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2002-07-01

Regulatory Status

Discontinued

2002
01 Jul
Discontinued Application: 76063

Drug Name

LISINOPRIL

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2002-07-01

76063 / 4

Active Ingredient

LISINOPRIL

Application Number

76063

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2002-07-01

Regulatory Status

Discontinued

2002
01 Jul
Discontinued Application: 76063

Drug Name

LISINOPRIL

Product Number

5

Dosage Form

-

Strength

40MG

Approval Date

2002-07-01

76063 / 5

Active Ingredient

LISINOPRIL

Application Number

76063

Product Number

5

Dosage Form

-

Strength

40MG

Approval Date

2002-07-01

Regulatory Status

Discontinued

2003
27 Jun
Discontinued Application: 76063

Drug Name

LISINOPRIL

Product Number

6

Dosage Form

-

Strength

30MG

Approval Date

2003-06-27

76063 / 6

Active Ingredient

LISINOPRIL

Application Number

76063

Product Number

6

Dosage Form

-

Strength

30MG

Approval Date

2003-06-27

Regulatory Status

Discontinued

2002
08 Jul
Discontinued Application: 76265

Drug Name

LISINOPRIL AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

12.5MG;10MG

Approval Date

2002-07-08

76265 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; LISINOPRIL

Application Number

76265

Product Number

1

Dosage Form

-

Strength

12.5MG;10MG

Approval Date

2002-07-08

Regulatory Status

Discontinued

2002
08 Jul
Discontinued Application: 76265

Drug Name

LISINOPRIL AND HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

12.5MG;20MG

Approval Date

2002-07-08

76265 / 2

Active Ingredient

HYDROCHLOROTHIAZIDE; LISINOPRIL

Application Number

76265

Product Number

2

Dosage Form

-

Strength

12.5MG;20MG

Approval Date

2002-07-08

Regulatory Status

Discontinued

2002
08 Jul
Discontinued Application: 76265

Drug Name

LISINOPRIL AND HYDROCHLOROTHIAZIDE

Product Number

3

Dosage Form

-

Strength

25MG;20MG

Approval Date

2002-07-08

76265 / 3

Active Ingredient

HYDROCHLOROTHIAZIDE; LISINOPRIL

Application Number

76265

Product Number

3

Dosage Form

-

Strength

25MG;20MG

Approval Date

2002-07-08

Regulatory Status

Discontinued

1982
01 Jan
RX Application: 17812

Drug Name

LITHIUM CARBONATE

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

1982-01-01

17812 / 1

Active Ingredient

LITHIUM CARBONATE

Application Number

17812

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

1982-01-01

Regulatory Status

RX

1987
28 Jan
RX Application: 17812

Drug Name

LITHIUM CARBONATE

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

1987-01-28

17812 / 2

Active Ingredient

LITHIUM CARBONATE

Application Number

17812

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

1987-01-28

Regulatory Status

RX

1987
28 Jan
RX Application: 17812

Drug Name

LITHIUM CARBONATE

Product Number

3

Dosage Form

-

Strength

600MG

Approval Date

1987-01-28

17812 / 3

Active Ingredient

LITHIUM CARBONATE

Application Number

17812

Product Number

3

Dosage Form

-

Strength

600MG

Approval Date

1987-01-28

Regulatory Status

RX

1982
29 Jan
RX Application: 18558

Drug Name

LITHIUM CARBONATE

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

1982-01-29

18558 / 1

Active Ingredient

LITHIUM CARBONATE

Application Number

18558

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

1982-01-29

Regulatory Status

RX

2003
17 Jun
Discontinued Application: 76490

Drug Name

LITHIUM CARBONATE

Product Number

1

Dosage Form

-

Strength

450MG

Approval Date

2003-06-17

76490 / 1

Active Ingredient

LITHIUM CARBONATE

Application Number

76490

Product Number

1

Dosage Form

-

Strength

450MG

Approval Date

2003-06-17

Regulatory Status

Discontinued

2004
05 Jan
RX Application: 76691

Drug Name

LITHIUM CARBONATE

Product Number

1

Dosage Form

-

Strength

450MG

Approval Date

2004-01-05

76691 / 1

Active Ingredient

LITHIUM CARBONATE

Application Number

76691

Product Number

1

Dosage Form

-

Strength

450MG

Approval Date

2004-01-05

Regulatory Status

RX

2004
28 Oct
RX Application: 76832

Drug Name

LITHIUM CARBONATE

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

2004-10-28

76832 / 1

Active Ingredient

LITHIUM CARBONATE

Application Number

76832

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

2004-10-28

Regulatory Status

RX

2010
28 Dec
Discontinued Application: 78715

Drug Name

LITHIUM CARBONATE

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

2010-12-28

78715 / 1

Active Ingredient

LITHIUM CARBONATE

Application Number

78715

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

2010-12-28

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 18421

Drug Name

LITHIUM CITRATE

Product Number

1

Dosage Form

-

Strength

EQ 300MG CARBONATE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

18421 / 1

Active Ingredient

LITHIUM CITRATE

Application Number

18421

Product Number

1

Dosage Form

-

Strength

EQ 300MG CARBONATE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1998
28 Sep
Discontinued Application: 74496

Drug Name

LORAZEPAM

Product Number

1

Dosage Form

-

Strength

2MG/ML

Approval Date

1998-09-28

74496 / 1

Active Ingredient

LORAZEPAM

Application Number

74496

Product Number

1

Dosage Form

-

Strength

2MG/ML

Approval Date

1998-09-28

Regulatory Status

Discontinued

1998
28 Sep
Discontinued Application: 74496

Drug Name

LORAZEPAM

Product Number

2

Dosage Form

-

Strength

4MG/ML

Approval Date

1998-09-28

74496 / 2

Active Ingredient

LORAZEPAM

Application Number

74496

Product Number

2

Dosage Form

-

Strength

4MG/ML

Approval Date

1998-09-28

Regulatory Status

Discontinued

2012
30 Jan
Discontinued Application: 200169

Drug Name

LORAZEPAM

Product Number

1

Dosage Form

-

Strength

2MG/ML

Approval Date

2012-01-30

200169 / 1

Active Ingredient

LORAZEPAM

Application Number

200169

Product Number

1

Dosage Form

-

Strength

2MG/ML

Approval Date

2012-01-30

Regulatory Status

Discontinued

1991
28 Jun
RX Application: 72755

Drug Name

LORAZEPAM INTENSOL

Product Number

1

Dosage Form

-

Strength

2MG/ML

Approval Date

1991-06-28

72755 / 1

Active Ingredient

LORAZEPAM

Application Number

72755

Product Number

1

Dosage Form

-

Strength

2MG/ML

Approval Date

1991-06-28

Regulatory Status

RX

2010
06 Oct
Discontinued Application: 77459

Drug Name

LOSARTAN POTASSIUM

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2010-10-06

77459 / 1

Active Ingredient

LOSARTAN POTASSIUM

Application Number

77459

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2010-10-06

Regulatory Status

Discontinued

2010
06 Oct
Discontinued Application: 77459

Drug Name

LOSARTAN POTASSIUM

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2010-10-06

77459 / 2

Active Ingredient

LOSARTAN POTASSIUM

Application Number

77459

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2010-10-06

Regulatory Status

Discontinued

2010
06 Oct
Discontinued Application: 77459

Drug Name

LOSARTAN POTASSIUM

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2010-10-06

77459 / 3

Active Ingredient

LOSARTAN POTASSIUM

Application Number

77459

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2010-10-06

Regulatory Status

Discontinued

2010
06 Apr
Discontinued Application: 77732

Drug Name

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

12.5MG;100MG

Approval Date

2010-04-06

77732 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM

Application Number

77732

Product Number

1

Dosage Form

-

Strength

12.5MG;100MG

Approval Date

2010-04-06

Regulatory Status

Discontinued

2010
06 Oct
Discontinued Application: 77732

Drug Name

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

12.5MG;50MG

Approval Date

2010-10-06

77732 / 2

Active Ingredient

HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM

Application Number

77732

Product Number

2

Dosage Form

-

Strength

12.5MG;50MG

Approval Date

2010-10-06

Regulatory Status

Discontinued

2010
06 Oct
Discontinued Application: 77732

Drug Name

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

Product Number

3

Dosage Form

-

Strength

25MG;100MG

Approval Date

2010-10-06

77732 / 3

Active Ingredient

HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM

Application Number

77732

Product Number

3

Dosage Form

-

Strength

25MG;100MG

Approval Date

2010-10-06

Regulatory Status

Discontinued

2023
29 Nov
Discontinued Application: 213956

Drug Name

LOTEPREDNOL ETABONATE

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

2023-11-29

213956 / 1

Active Ingredient

LOTEPREDNOL ETABONATE

Application Number

213956

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

2023-11-29

Regulatory Status

Discontinued

2023
05 Jan
Discontinued Application: 214309

Drug Name

MEDROXYPROGESTERONE ACETATE

Product Number

1

Dosage Form

-

Strength

150MG/ML

Approval Date

2023-01-05

214309 / 1

Active Ingredient

MEDROXYPROGESTERONE ACETATE

Application Number

214309

Product Number

1

Dosage Form

-

Strength

150MG/ML

Approval Date

2023-01-05

Regulatory Status

Discontinued

2004
01 Oct
Discontinued Application: 76523

Drug Name

MEFLOQUINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2004-10-01

76523 / 1

Active Ingredient

MEFLOQUINE HYDROCHLORIDE

Application Number

76523

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2004-10-01

Regulatory Status

Discontinued

2010
21 Apr
Discontinued Application: 77699

Drug Name

MEFLOQUINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2010-04-21

77699 / 1

Active Ingredient

MEFLOQUINE HYDROCHLORIDE

Application Number

77699

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2010-04-21

Regulatory Status

Discontinued

1995
29 Sep
Discontinued Application: 74458

Drug Name

MEGESTROL ACETATE

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

1995-09-29

74458 / 1

Active Ingredient

MEGESTROL ACETATE

Application Number

74458

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

1995-09-29

Regulatory Status

Discontinued

1995
29 Sep
Discontinued Application: 74458

Drug Name

MEGESTROL ACETATE

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

1995-09-29

74458 / 2

Active Ingredient

MEGESTROL ACETATE

Application Number

74458

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

1995-09-29

Regulatory Status

Discontinued

2002
15 Feb
Discontinued Application: 75997

Drug Name

MEGESTROL ACETATE

Product Number

1

Dosage Form

-

Strength

40MG/ML

Approval Date

2002-02-15

75997 / 1

Active Ingredient

MEGESTROL ACETATE

Application Number

75997

Product Number

1

Dosage Form

-

Strength

40MG/ML

Approval Date

2002-02-15

Regulatory Status

Discontinued

2017
09 Jun
Discontinued Application: 203960

Drug Name

MEGESTROL ACETATE

Product Number

1

Dosage Form

-

Strength

40MG/ML

Approval Date

2017-06-09

203960 / 1

Active Ingredient

MEGESTROL ACETATE

Application Number

203960

Product Number

1

Dosage Form

-

Strength

40MG/ML

Approval Date

2017-06-09

Regulatory Status

Discontinued

2010
28 Oct
RX Application: 90303

Drug Name

MELPHALAN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/VIAL

Approval Date

2010-10-28

90303 / 1

Active Ingredient

MELPHALAN HYDROCHLORIDE

Application Number

90303

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/VIAL

Approval Date

2010-10-28

Regulatory Status

RX

2020
28 Feb
Discontinued Application: 208173

Drug Name

MEMANTINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2020-02-28

208173 / 1

Active Ingredient

MEMANTINE HYDROCHLORIDE

Application Number

208173

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2020-02-28

Regulatory Status

Discontinued

2020
28 Feb
Discontinued Application: 208173

Drug Name

MEMANTINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2020-02-28

208173 / 2

Active Ingredient

MEMANTINE HYDROCHLORIDE

Application Number

208173

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2020-02-28

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 11730

Drug Name

MEPERGAN

Product Number

1

Dosage Form

-

Strength

25MG/ML;25MG/ML

Approval Date

1982-01-01

11730 / 1

Active Ingredient

MEPERIDINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE

Application Number

11730

Product Number

1

Dosage Form

-

Strength

25MG/ML;25MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1997
12 Mar
Discontinued Application: 40110

Drug Name

MEPERIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1997-03-12

40110 / 1

Active Ingredient

MEPERIDINE HYDROCHLORIDE

Application Number

40110

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1997-03-12

Regulatory Status

Discontinued

1997
12 Mar
Discontinued Application: 40110

Drug Name

MEPERIDINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

1997-03-12

40110 / 2

Active Ingredient

MEPERIDINE HYDROCHLORIDE

Application Number

40110

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

1997-03-12

Regulatory Status

Discontinued

1985
30 Jan
RX Application: 88744

Drug Name

MEPERIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG/5ML

Approval Date

1985-01-30

88744 / 1

Active Ingredient

MEPERIDINE HYDROCHLORIDE

Application Number

88744

Product Number

1

Dosage Form

-

Strength

50MG/5ML

Approval Date

1985-01-30

Regulatory Status

RX

2004
13 Feb
RX Application: 40528

Drug Name

MERCAPTOPURINE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2004-02-13

40528 / 1

Active Ingredient

MERCAPTOPURINE

Application Number

40528

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2004-02-13

Regulatory Status

RX

2025
26 Feb
RX Application: 216418

Drug Name

MERCAPTOPURINE

Product Number

1

Dosage Form

-

Strength

20MG/ML

Approval Date

2025-02-26

216418 / 1

Active Ingredient

MERCAPTOPURINE

Application Number

216418

Product Number

1

Dosage Form

-

Strength

20MG/ML

Approval Date

2025-02-26

Regulatory Status

RX

2004
09 Jan
RX Application: 75739

Drug Name

MESNA

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2004-01-09

75739 / 1

Active Ingredient

MESNA

Application Number

75739

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2004-01-09

Regulatory Status

RX

-
Unclassified Application: 75739

Drug Name

MESNA

Product Number

2

Dosage Form

-

Strength

1G/10ML

Approval Date

-

75739 / 2

Active Ingredient

MESNA

Application Number

75739

Product Number

2

Dosage Form

-

Strength

1G/10ML

Approval Date

-

Regulatory Status

Unclassified

1982
01 Jan
RX Application: 17058

Drug Name

METHADONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

1982-01-01

17058 / 1

Active Ingredient

METHADONE HYDROCHLORIDE

Application Number

17058

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

1982-01-01

Regulatory Status

RX

1998
30 Apr
RX Application: 40180

Drug Name

METHADONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1998-04-30

40180 / 1

Active Ingredient

METHADONE HYDROCHLORIDE

Application Number

40180

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1998-04-30

Regulatory Status

RX

1982
01 Jan
RX Application: 87393

Drug Name

METHADONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG/5ML

Approval Date

1982-01-01

87393 / 1

Active Ingredient

METHADONE HYDROCHLORIDE

Application Number

87393

Product Number

1

Dosage Form

-

Strength

5MG/5ML

Approval Date

1982-01-01

Regulatory Status

RX

1982
30 Aug
RX Application: 87997

Drug Name

METHADONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG/5ML

Approval Date

1982-08-30

87997 / 1

Active Ingredient

METHADONE HYDROCHLORIDE

Application Number

87997

Product Number

1

Dosage Form

-

Strength

10MG/5ML

Approval Date

1982-08-30

Regulatory Status

RX

1983
08 Mar
RX Application: 88109

Drug Name

METHADONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1983-03-08

88109 / 1

Active Ingredient

METHADONE HYDROCHLORIDE

Application Number

88109

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1983-03-08

Regulatory Status

RX

1983
08 Mar
RX Application: 88109

Drug Name

METHADONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

1983-03-08

88109 / 2

Active Ingredient

METHADONE HYDROCHLORIDE

Application Number

88109

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

1983-03-08

Regulatory Status

RX

2025
05 May
RX Application: 218609

Drug Name

METHADONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2025-05-05

218609 / 1

Active Ingredient

METHADONE HYDROCHLORIDE

Application Number

218609

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2025-05-05

Regulatory Status

RX

1988
06 Sep
RX Application: 89897

Drug Name

METHADONE HYDROCHLORIDE INTENSOL

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1988-09-06

89897 / 1

Active Ingredient

METHADONE HYDROCHLORIDE

Application Number

89897

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1988-09-06

Regulatory Status

RX

2015
17 Nov
RX Application: 203846

Drug Name

METHAMPHETAMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2015-11-17

203846 / 1

Active Ingredient

METHAMPHETAMINE HYDROCHLORIDE

Application Number

203846

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2015-11-17

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 85123

Drug Name

METHOCARBAMOL

Product Number

1

Dosage Form

-

Strength

750MG

Approval Date

1982-01-01

85123 / 1

Active Ingredient

METHOCARBAMOL

Application Number

85123

Product Number

1

Dosage Form

-

Strength

750MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85123

Drug Name

METHOCARBAMOL

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

85123 / 2

Active Ingredient

METHOCARBAMOL

Application Number

85123

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

-
Unclassified Application: 85159

Drug Name

METHOCARBAMOL

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

-

85159 / 1

Active Ingredient

METHOCARBAMOL

Application Number

85159

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

-

Regulatory Status

Unclassified

1994
01 Aug
RX Application: 40054

Drug Name

METHOTREXATE SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

1994-08-01

40054 / 1

Active Ingredient

METHOTREXATE SODIUM

Application Number

40054

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

1994-08-01

Regulatory Status

RX

1986
16 Sep
RX Application: 89341

Drug Name

METHOTREXATE SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE/4ML (EQ 25MG BASE/ML)

Approval Date

1986-09-16

89341 / 1

Active Ingredient

METHOTREXATE SODIUM

Application Number

89341

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE/4ML (EQ 25MG BASE/ML)

Approval Date

1986-09-16

Regulatory Status

RX

1986
16 Sep
RX Application: 89342

Drug Name

METHOTREXATE SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE/8ML (EQ 25MG BASE/ML)

Approval Date

1986-09-16

89342 / 1

Active Ingredient

METHOTREXATE SODIUM

Application Number

89342

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE/8ML (EQ 25MG BASE/ML)

Approval Date

1986-09-16

Regulatory Status

RX

2005
12 Aug
RX Application: 40632

Drug Name

METHOTREXATE SODIUM PRESERVATIVE FREE

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2005-08-12

40632 / 1

Active Ingredient

METHOTREXATE SODIUM

Application Number

40632

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2005-08-12

Regulatory Status

RX

1986
16 Sep
RX Application: 89340

Drug Name

METHOTREXATE SODIUM PRESERVATIVE FREE

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/2ML (EQ 25MG BASE/ML)

Approval Date

1986-09-16

89340 / 1

Active Ingredient

METHOTREXATE SODIUM

Application Number

89340

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/2ML (EQ 25MG BASE/ML)

Approval Date

1986-09-16

Regulatory Status

RX

1986
16 Sep
RX Application: 89343

Drug Name

METHOTREXATE SODIUM PRESERVATIVE FREE

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE/10ML (EQ 25MG BASE/ML)

Approval Date

1986-09-16

89343 / 1

Active Ingredient

METHOTREXATE SODIUM

Application Number

89343

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE/10ML (EQ 25MG BASE/ML)

Approval Date

1986-09-16

Regulatory Status

RX

2024
17 Dec
RX Application: 216959

Drug Name

METHYLENE BLUE

Product Number

1

Dosage Form

-

Strength

50MG/10ML (5MG/ML)

Approval Date

2024-12-17

216959 / 1

Active Ingredient

METHYLENE BLUE

Application Number

216959

Product Number

1

Dosage Form

-

Strength

50MG/10ML (5MG/ML)

Approval Date

2024-12-17

Regulatory Status

RX

2025
16 Apr
RX Application: 219145

Drug Name

METHYLPREDNISOLONE ACETATE

Product Number

1

Dosage Form

-

Strength

80MG/ML

Approval Date

2025-04-16

219145 / 1

Active Ingredient

METHYLPREDNISOLONE ACETATE

Application Number

219145

Product Number

1

Dosage Form

-

Strength

80MG/ML

Approval Date

2025-04-16

Regulatory Status

RX

2016
16 Feb
RX Application: 202691

Drug Name

METHYLPREDNISOLONE SODIUM SUCCINATE

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2016-02-16

202691 / 1

Active Ingredient

METHYLPREDNISOLONE SODIUM SUCCINATE

Application Number

202691

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2016-02-16

Regulatory Status

RX

2016
16 Feb
RX Application: 202691

Drug Name

METHYLPREDNISOLONE SODIUM SUCCINATE

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2016-02-16

202691 / 2

Active Ingredient

METHYLPREDNISOLONE SODIUM SUCCINATE

Application Number

202691

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2016-02-16

Regulatory Status

RX

2022
26 Sep
RX Application: 203125

Drug Name

METHYLPREDNISOLONE SODIUM SUCCINATE

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE/VIAL

Approval Date

2022-09-26

203125 / 1

Active Ingredient

METHYLPREDNISOLONE SODIUM SUCCINATE

Application Number

203125

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE/VIAL

Approval Date

2022-09-26

Regulatory Status

RX

2022
26 Sep
RX Application: 203125

Drug Name

METHYLPREDNISOLONE SODIUM SUCCINATE

Product Number

2

Dosage Form

-

Strength

EQ 125MG BASE/VIAL

Approval Date

2022-09-26

203125 / 2

Active Ingredient

METHYLPREDNISOLONE SODIUM SUCCINATE

Application Number

203125

Product Number

2

Dosage Form

-

Strength

EQ 125MG BASE/VIAL

Approval Date

2022-09-26

Regulatory Status

RX

2003
07 Jul
RX Application: 76495

Drug Name

METOPROLOL TARTRATE

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2003-07-07

76495 / 1

Active Ingredient

METOPROLOL TARTRATE

Application Number

76495

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2003-07-07

Regulatory Status

RX

2007
30 May
RX Application: 77761

Drug Name

METOPROLOL TARTRATE

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2007-05-30

77761 / 1

Active Ingredient

METOPROLOL TARTRATE

Application Number

77761

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2007-05-30

Regulatory Status

RX

1984
30 Mar
Discontinued Application: 18907

Drug Name

METRONIDAZOLE

Product Number

1

Dosage Form

-

Strength

500MG/100ML

Approval Date

1984-03-30

18907 / 1

Active Ingredient

METRONIDAZOLE

Application Number

18907

Product Number

1

Dosage Form

-

Strength

500MG/100ML

Approval Date

1984-03-30

Regulatory Status

Discontinued

2021
09 Jul
RX Application: 213261

Drug Name

MICAFUNGIN SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/VIAL

Approval Date

2021-07-09

213261 / 1

Active Ingredient

MICAFUNGIN SODIUM

Application Number

213261

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/VIAL

Approval Date

2021-07-09

Regulatory Status

RX

2021
09 Jul
RX Application: 213261

Drug Name

MICAFUNGIN SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE/VIAL

Approval Date

2021-07-09

213261 / 2

Active Ingredient

MICAFUNGIN SODIUM

Application Number

213261

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE/VIAL

Approval Date

2021-07-09

Regulatory Status

RX

2000
20 Jun
RX Application: 75243

Drug Name

MIDAZOLAM HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2000-06-20

75243 / 1

Active Ingredient

MIDAZOLAM HYDROCHLORIDE

Application Number

75243

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2000-06-20

Regulatory Status

RX

2000
20 Jun
RX Application: 75243

Drug Name

MIDAZOLAM HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

2000-06-20

75243 / 2

Active Ingredient

MIDAZOLAM HYDROCHLORIDE

Application Number

75243

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

2000-06-20

Regulatory Status

RX

2000
23 Jun
RX Application: 75247

Drug Name

MIDAZOLAM HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

2000-06-23

75247 / 1

Active Ingredient

MIDAZOLAM HYDROCHLORIDE

Application Number

75247

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

2000-06-23

Regulatory Status

RX

2000
23 Jun
RX Application: 75247

Drug Name

MIDAZOLAM HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2000-06-23

75247 / 2

Active Ingredient

MIDAZOLAM HYDROCHLORIDE

Application Number

75247

Product Number

2

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2000-06-23

Regulatory Status

RX

2000
20 Jun
RX Application: 75324

Drug Name

MIDAZOLAM HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2000-06-20

75324 / 1

Active Ingredient

MIDAZOLAM HYDROCHLORIDE

Application Number

75324

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2000-06-20

Regulatory Status

RX

2000
20 Jun
RX Application: 75324

Drug Name

MIDAZOLAM HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

2000-06-20

75324 / 2

Active Ingredient

MIDAZOLAM HYDROCHLORIDE

Application Number

75324

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

2000-06-20

Regulatory Status

RX

2000
20 Jun
RX Application: 75421

Drug Name

MIDAZOLAM HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

2000-06-20

75421 / 1

Active Ingredient

MIDAZOLAM HYDROCHLORIDE

Application Number

75421

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

2000-06-20

Regulatory Status

RX

2000
20 Jun
RX Application: 75421

Drug Name

MIDAZOLAM HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2000-06-20

75421 / 2

Active Ingredient

MIDAZOLAM HYDROCHLORIDE

Application Number

75421

Product Number

2

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2000-06-20

Regulatory Status

RX

2002
30 Apr
RX Application: 75873

Drug Name

MIDAZOLAM HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2002-04-30

75873 / 1

Active Ingredient

MIDAZOLAM HYDROCHLORIDE

Application Number

75873

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2002-04-30

Regulatory Status

RX

2020
11 Dec
RX Application: 212847

Drug Name

MIDAZOLAM HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2020-12-11

212847 / 1

Active Ingredient

MIDAZOLAM HYDROCHLORIDE

Application Number

212847

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2020-12-11

Regulatory Status

RX

2020
11 Dec
RX Application: 212847

Drug Name

MIDAZOLAM HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

2020-12-11

212847 / 2

Active Ingredient

MIDAZOLAM HYDROCHLORIDE

Application Number

212847

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

2020-12-11

Regulatory Status

RX

2023
17 Apr
RX Application: 216159

Drug Name

MIDAZOLAM IN 0.9% SODIUM CHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG/50ML (1MG/ML)

Approval Date

2023-04-17

216159 / 1

Active Ingredient

MIDAZOLAM

Application Number

216159

Product Number

1

Dosage Form

-

Strength

50MG/50ML (1MG/ML)

Approval Date

2023-04-17

Regulatory Status

RX

2023
17 Apr
RX Application: 216159

Drug Name

MIDAZOLAM IN 0.9% SODIUM CHLORIDE

Product Number

2

Dosage Form

-

Strength

100MG/100ML (1MG/ML)

Approval Date

2023-04-17

216159 / 2

Active Ingredient

MIDAZOLAM

Application Number

216159

Product Number

2

Dosage Form

-

Strength

100MG/100ML (1MG/ML)

Approval Date

2023-04-17

Regulatory Status

RX

2002
28 May
Discontinued Application: 75530

Drug Name

MILRINONE LACTATE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2002-05-28

75530 / 1

Active Ingredient

MILRINONE LACTATE

Application Number

75530

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2002-05-28

Regulatory Status

Discontinued

2002
28 May
RX Application: 75660

Drug Name

MILRINONE LACTATE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2002-05-28

75660 / 1

Active Ingredient

MILRINONE LACTATE

Application Number

75660

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2002-05-28

Regulatory Status

RX

-
Unclassified Application: 75660

Drug Name

MILRINONE LACTATE

Product Number

2

Dosage Form

-

Strength

EQ 20MG /20ML (1MG/ML)

Approval Date

-

75660 / 2

Active Ingredient

MILRINONE LACTATE

Application Number

75660

Product Number

2

Dosage Form

-

Strength

EQ 20MG /20ML (1MG/ML)

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 75660

Drug Name

MILRINONE LACTATE

Product Number

3

Dosage Form

-

Strength

EQ 50MG /50ML (1MG/ML)

Approval Date

-

75660 / 3

Active Ingredient

MILRINONE LACTATE

Application Number

75660

Product Number

3

Dosage Form

-

Strength

EQ 50MG /50ML (1MG/ML)

Approval Date

-

Regulatory Status

Unclassified

2002
28 May
Discontinued Application: 75852

Drug Name

MILRINONE LACTATE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2002-05-28

75852 / 1

Active Ingredient

MILRINONE LACTATE

Application Number

75852

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2002-05-28

Regulatory Status

Discontinued

2010
03 Dec
RX Application: 77966

Drug Name

MILRINONE LACTATE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2010-12-03

77966 / 1

Active Ingredient

MILRINONE LACTATE

Application Number

77966

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2010-12-03

Regulatory Status

RX

2002
28 May
Discontinued Application: 75510

Drug Name

MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)

Approval Date

2002-05-28

75510 / 1

Active Ingredient

MILRINONE LACTATE

Application Number

75510

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)

Approval Date

2002-05-28

Regulatory Status

Discontinued

2008
21 May
RX Application: 78113

Drug Name

MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)

Approval Date

2008-05-21

78113 / 1

Active Ingredient

MILRINONE LACTATE

Application Number

78113

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)

Approval Date

2008-05-21

Regulatory Status

RX

2008
21 May
RX Application: 78113

Drug Name

MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)

Approval Date

2008-05-21

78113 / 2

Active Ingredient

MILRINONE LACTATE

Application Number

78113

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)

Approval Date

2008-05-21

Regulatory Status

RX

2010
21 Jan
RX Application: 90038

Drug Name

MILRINONE LACTATE IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)

Approval Date

2010-01-21

90038 / 1

Active Ingredient

MILRINONE LACTATE

Application Number

90038

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)

Approval Date

2010-01-21

Regulatory Status

RX

2010
21 Jan
RX Application: 90038

Drug Name

MILRINONE LACTATE IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)

Approval Date

2010-01-21

90038 / 2

Active Ingredient

MILRINONE LACTATE

Application Number

90038

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)

Approval Date

2010-01-21

Regulatory Status

RX

1996
24 Dec
Discontinued Application: 74731

Drug Name

MINOXIDIL (FOR MEN)

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1996-12-24

74731 / 1

Active Ingredient

MINOXIDIL

Application Number

74731

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1996-12-24

Regulatory Status

Discontinued

2005
11 May
Discontinued Application: 74731

Drug Name

MINOXIDIL (FOR WOMEN)

Product Number

2

Dosage Form

-

Strength

2%

Approval Date

2005-05-11

74731 / 2

Active Ingredient

MINOXIDIL

Application Number

74731

Product Number

2

Dosage Form

-

Strength

2%

Approval Date

2005-05-11

Regulatory Status

Discontinued

2014
26 Sep
RX Application: 204820

Drug Name

MITIGARE

Product Number

1

Dosage Form

-

Strength

0.6MG

Approval Date

2014-09-26

204820 / 1

Active Ingredient

COLCHICINE

Application Number

204820

Product Number

1

Dosage Form

-

Strength

0.6MG

Approval Date

2014-09-26

Regulatory Status

RX

1995
19 Apr
Discontinued Application: 64117

Drug Name

MITOMYCIN

Product Number

1

Dosage Form

-

Strength

5MG/VIAL

Approval Date

1995-04-19

64117 / 1

Active Ingredient

MITOMYCIN

Application Number

64117

Product Number

1

Dosage Form

-

Strength

5MG/VIAL

Approval Date

1995-04-19

Regulatory Status

Discontinued

1995
19 Apr
RX Application: 64117

Drug Name

MITOMYCIN

Product Number

2

Dosage Form

-

Strength

20MG/VIAL

Approval Date

1995-04-19

64117 / 2

Active Ingredient

MITOMYCIN

Application Number

64117

Product Number

2

Dosage Form

-

Strength

20MG/VIAL

Approval Date

1995-04-19

Regulatory Status

RX

1999
02 Jun
RX Application: 64117

Drug Name

MITOMYCIN

Product Number

3

Dosage Form

-

Strength

40MG/VIAL

Approval Date

1999-06-02

64117 / 3

Active Ingredient

MITOMYCIN

Application Number

64117

Product Number

3

Dosage Form

-

Strength

40MG/VIAL

Approval Date

1999-06-02

Regulatory Status

RX

1999
23 Dec
RX Application: 64180

Drug Name

MITOMYCIN

Product Number

1

Dosage Form

-

Strength

5MG/VIAL

Approval Date

1999-12-23

64180 / 1

Active Ingredient

MITOMYCIN

Application Number

64180

Product Number

1

Dosage Form

-

Strength

5MG/VIAL

Approval Date

1999-12-23

Regulatory Status

RX

1999
23 Dec
RX Application: 64180

Drug Name

MITOMYCIN

Product Number

2

Dosage Form

-

Strength

20MG/VIAL

Approval Date

1999-12-23

64180 / 2

Active Ingredient

MITOMYCIN

Application Number

64180

Product Number

2

Dosage Form

-

Strength

20MG/VIAL

Approval Date

1999-12-23

Regulatory Status

RX

2006
11 Apr
RX Application: 76611

Drug Name

MITOXANTRONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE/10ML (EQ 2MG BASE/ML)

Approval Date

2006-04-11

76611 / 1

Active Ingredient

MITOXANTRONE HYDROCHLORIDE

Application Number

76611

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE/10ML (EQ 2MG BASE/ML)

Approval Date

2006-04-11

Regulatory Status

RX

2006
11 Apr
RX Application: 76611

Drug Name

MITOXANTRONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)

Approval Date

2006-04-11

76611 / 2

Active Ingredient

MITOXANTRONE HYDROCHLORIDE

Application Number

76611

Product Number

2

Dosage Form

-

Strength

EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML)

Approval Date

2006-04-11

Regulatory Status

RX

2006
11 Apr
RX Application: 76611

Drug Name

MITOXANTRONE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 30MG BASE/15ML (EQ 2MG BASE/ML)

Approval Date

2006-04-11

76611 / 3

Active Ingredient

MITOXANTRONE HYDROCHLORIDE

Application Number

76611

Product Number

3

Dosage Form

-

Strength

EQ 30MG BASE/15ML (EQ 2MG BASE/ML)

Approval Date

2006-04-11

Regulatory Status

RX

2012
26 Sep
Discontinued Application: 90543

Drug Name

MODAFINIL

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2012-09-26

90543 / 1

Active Ingredient

MODAFINIL

Application Number

90543

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2012-09-26

Regulatory Status

Discontinued

2012
26 Sep
Discontinued Application: 90543

Drug Name

MODAFINIL

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2012-09-26

90543 / 2

Active Ingredient

MODAFINIL

Application Number

90543

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2012-09-26

Regulatory Status

Discontinued

2012
03 Aug
Discontinued Application: 90655

Drug Name

MONTELUKAST SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2012-08-03

90655 / 1

Active Ingredient

MONTELUKAST SODIUM

Application Number

90655

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2012-08-03

Regulatory Status

Discontinued

2012
03 Aug
Discontinued Application: 91128

Drug Name

MONTELUKAST SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2012-08-03

91128 / 1

Active Ingredient

MONTELUKAST SODIUM

Application Number

91128

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2012-08-03

Regulatory Status

Discontinued

2012
03 Aug
Discontinued Application: 91128

Drug Name

MONTELUKAST SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2012-08-03

91128 / 2

Active Ingredient

MONTELUKAST SODIUM

Application Number

91128

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2012-08-03

Regulatory Status

Discontinued

2008
17 Mar
RX Application: 22195

Drug Name

MORPHINE SULFATE

Product Number

1

Dosage Form

-

Strength

10MG/5ML

Approval Date

2008-03-17

22195 / 1

Active Ingredient

MORPHINE SULFATE

Application Number

22195

Product Number

1

Dosage Form

-

Strength

10MG/5ML

Approval Date

2008-03-17

Regulatory Status

RX

2008
17 Mar
RX Application: 22195

Drug Name

MORPHINE SULFATE

Product Number

2

Dosage Form

-

Strength

20MG/5ML

Approval Date

2008-03-17

22195 / 2

Active Ingredient

MORPHINE SULFATE

Application Number

22195

Product Number

2

Dosage Form

-

Strength

20MG/5ML

Approval Date

2008-03-17

Regulatory Status

RX

2010
25 Jan
RX Application: 22195

Drug Name

MORPHINE SULFATE

Product Number

3

Dosage Form

-

Strength

100MG/5ML

Approval Date

2010-01-25

22195 / 3

Active Ingredient

MORPHINE SULFATE

Application Number

22195

Product Number

3

Dosage Form

-

Strength

100MG/5ML

Approval Date

2010-01-25

Regulatory Status

RX

2008
17 Mar
RX Application: 22207

Drug Name

MORPHINE SULFATE

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2008-03-17

22207 / 1

Active Ingredient

MORPHINE SULFATE

Application Number

22207

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2008-03-17

Regulatory Status

RX

2008
17 Mar
RX Application: 22207

Drug Name

MORPHINE SULFATE

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2008-03-17

22207 / 2

Active Ingredient

MORPHINE SULFATE

Application Number

22207

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2008-03-17

Regulatory Status

RX

2015
21 May
RX Application: 205758

Drug Name

MORPHINE SULFATE

Product Number

1

Dosage Form

-

Strength

4MG/ML

Approval Date

2015-05-21

205758 / 1

Active Ingredient

MORPHINE SULFATE

Application Number

205758

Product Number

1

Dosage Form

-

Strength

4MG/ML

Approval Date

2015-05-21

Regulatory Status

RX

2015
21 May
RX Application: 205758

Drug Name

MORPHINE SULFATE

Product Number

2

Dosage Form

-

Strength

8MG/ML

Approval Date

2015-05-21

205758 / 2

Active Ingredient

MORPHINE SULFATE

Application Number

205758

Product Number

2

Dosage Form

-

Strength

8MG/ML

Approval Date

2015-05-21

Regulatory Status

RX

2015
21 May
RX Application: 205758

Drug Name

MORPHINE SULFATE

Product Number

3

Dosage Form

-

Strength

10MG/ML

Approval Date

2015-05-21

205758 / 3

Active Ingredient

MORPHINE SULFATE

Application Number

205758

Product Number

3

Dosage Form

-

Strength

10MG/ML

Approval Date

2015-05-21

Regulatory Status

RX

2017
06 Jul
Discontinued Application: 208809

Drug Name

MORPHINE SULFATE

Product Number

1

Dosage Form

-

Strength

100MG/5ML

Approval Date

2017-07-06

208809 / 1

Active Ingredient

MORPHINE SULFATE

Application Number

208809

Product Number

1

Dosage Form

-

Strength

100MG/5ML

Approval Date

2017-07-06

Regulatory Status

Discontinued

2023
12 Jan
RX Application: 211452

Drug Name

MORPHINE SULFATE

Product Number

1

Dosage Form

-

Strength

2MG/ML

Approval Date

2023-01-12

211452 / 1

Active Ingredient

MORPHINE SULFATE

Application Number

211452

Product Number

1

Dosage Form

-

Strength

2MG/ML

Approval Date

2023-01-12

Regulatory Status

RX

2023
12 Jan
RX Application: 211452

Drug Name

MORPHINE SULFATE

Product Number

2

Dosage Form

-

Strength

4MG/ML

Approval Date

2023-01-12

211452 / 2

Active Ingredient

MORPHINE SULFATE

Application Number

211452

Product Number

2

Dosage Form

-

Strength

4MG/ML

Approval Date

2023-01-12

Regulatory Status

RX

2023
12 Jan
RX Application: 211452

Drug Name

MORPHINE SULFATE

Product Number

3

Dosage Form

-

Strength

8MG/ML

Approval Date

2023-01-12

211452 / 3

Active Ingredient

MORPHINE SULFATE

Application Number

211452

Product Number

3

Dosage Form

-

Strength

8MG/ML

Approval Date

2023-01-12

Regulatory Status

RX

2023
12 Jan
RX Application: 211452

Drug Name

MORPHINE SULFATE

Product Number

4

Dosage Form

-

Strength

10MG/ML

Approval Date

2023-01-12

211452 / 4

Active Ingredient

MORPHINE SULFATE

Application Number

211452

Product Number

4

Dosage Form

-

Strength

10MG/ML

Approval Date

2023-01-12

Regulatory Status

RX

2023
12 Jan
RX Application: 211452

Drug Name

MORPHINE SULFATE

Product Number

5

Dosage Form

-

Strength

15MG/ML

Approval Date

2023-01-12

211452 / 5

Active Ingredient

MORPHINE SULFATE

Application Number

211452

Product Number

5

Dosage Form

-

Strength

15MG/ML

Approval Date

2023-01-12

Regulatory Status

RX

2008
29 Jul
Discontinued Application: 65410

Drug Name

MYCOPHENOLATE MOFETIL

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2008-07-29

65410 / 1

Active Ingredient

MYCOPHENOLATE MOFETIL

Application Number

65410

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2008-07-29

Regulatory Status

Discontinued

2008
29 Jul
Discontinued Application: 65413

Drug Name

MYCOPHENOLATE MOFETIL

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2008-07-29

65413 / 1

Active Ingredient

MYCOPHENOLATE MOFETIL

Application Number

65413

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2008-07-29

Regulatory Status

Discontinued

1986
24 Sep
Discontinued Application: 70298

Drug Name

NALOXONE

Product Number

1

Dosage Form

-

Strength

0.4MG/ML

Approval Date

1986-09-24

70298 / 1

Active Ingredient

NALOXONE HYDROCHLORIDE

Application Number

70298

Product Number

1

Dosage Form

-

Strength

0.4MG/ML

Approval Date

1986-09-24

Regulatory Status

Discontinued

1986
24 Sep
RX Application: 70299

Drug Name

NALOXONE

Product Number

1

Dosage Form

-

Strength

0.4MG/ML

Approval Date

1986-09-24

70299 / 1

Active Ingredient

NALOXONE HYDROCHLORIDE

Application Number

70299

Product Number

1

Dosage Form

-

Strength

0.4MG/ML

Approval Date

1986-09-24

Regulatory Status

RX

1986
24 Sep
Discontinued Application: 70496

Drug Name

NALOXONE

Product Number

1

Dosage Form

-

Strength

0.4MG/ML

Approval Date

1986-09-24

70496 / 1

Active Ingredient

NALOXONE HYDROCHLORIDE

Application Number

70496

Product Number

1

Dosage Form

-

Strength

0.4MG/ML

Approval Date

1986-09-24

Regulatory Status

Discontinued

1988
24 May
Discontinued Application: 71272

Drug Name

NALOXONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.02MG/ML

Approval Date

1988-05-24

71272 / 1

Active Ingredient

NALOXONE HYDROCHLORIDE

Application Number

71272

Product Number

1

Dosage Form

-

Strength

0.02MG/ML

Approval Date

1988-05-24

Regulatory Status

Discontinued

1988
24 May
Discontinued Application: 71273

Drug Name

NALOXONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

1988-05-24

71273 / 1

Active Ingredient

NALOXONE HYDROCHLORIDE

Application Number

71273

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

1988-05-24

Regulatory Status

Discontinued

1988
24 May
Discontinued Application: 71274

Drug Name

NALOXONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

1988-05-24

71274 / 1

Active Ingredient

NALOXONE HYDROCHLORIDE

Application Number

71274

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

1988-05-24

Regulatory Status

Discontinued

1988
24 May
Discontinued Application: 71287

Drug Name

NALOXONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

1988-05-24

71287 / 1

Active Ingredient

NALOXONE HYDROCHLORIDE

Application Number

71287

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

1988-05-24

Regulatory Status

Discontinued

2022
10 Jun
RX Application: 212300

Drug Name

NALOXONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2022-06-10

212300 / 1

Active Ingredient

NALOXONE HYDROCHLORIDE

Application Number

212300

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2022-06-10

Regulatory Status

RX

2024
07 Mar
RX Application: 212300

Drug Name

NALOXONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

0.4MG/ML

Approval Date

2024-03-07

212300 / 2

Active Ingredient

NALOXONE HYDROCHLORIDE

Application Number

212300

Product Number

2

Dosage Form

-

Strength

0.4MG/ML

Approval Date

2024-03-07

Regulatory Status

RX

1994
30 Mar
RX Application: 74190

Drug Name

NAPROXEN

Product Number

1

Dosage Form

-

Strength

25MG/ML

Approval Date

1994-03-30

74190 / 1

Active Ingredient

NAPROXEN

Application Number

74190

Product Number

1

Dosage Form

-

Strength

25MG/ML

Approval Date

1994-03-30

Regulatory Status

RX

2004
14 Jan
Discontinued Application: 76494

Drug Name

NAPROXEN

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2004-01-14

76494 / 1

Active Ingredient

NAPROXEN

Application Number

76494

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2004-01-14

Regulatory Status

Discontinued

2004
14 Jan
Discontinued Application: 76494

Drug Name

NAPROXEN

Product Number

2

Dosage Form

-

Strength

375MG

Approval Date

2004-01-14

76494 / 2

Active Ingredient

NAPROXEN

Application Number

76494

Product Number

2

Dosage Form

-

Strength

375MG

Approval Date

2004-01-14

Regulatory Status

Discontinued

2004
14 Jan
Discontinued Application: 76494

Drug Name

NAPROXEN

Product Number

3

Dosage Form

-

Strength

500MG

Approval Date

2004-01-14

76494 / 3

Active Ingredient

NAPROXEN

Application Number

76494

Product Number

3

Dosage Form

-

Strength

500MG

Approval Date

2004-01-14

Regulatory Status

Discontinued

1996
14 May
Discontinued Application: 74480

Drug Name

NAPROXEN SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1996-05-14

74480 / 1

Active Ingredient

NAPROXEN SODIUM

Application Number

74480

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1996-05-14

Regulatory Status

Discontinued

1998
18 Feb
Discontinued Application: 74480

Drug Name

NAPROXEN SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1998-02-18

74480 / 2

Active Ingredient

NAPROXEN SODIUM

Application Number

74480

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1998-02-18

Regulatory Status

Discontinued

2010
07 Jul
RX Application: 90381

Drug Name

NARATRIPTAN

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2010-07-07

90381 / 1

Active Ingredient

NARATRIPTAN HYDROCHLORIDE

Application Number

90381

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2010-07-07

Regulatory Status

RX

2010
07 Jul
RX Application: 90381

Drug Name

NARATRIPTAN

Product Number

2

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2010-07-07

90381 / 2

Active Ingredient

NARATRIPTAN HYDROCHLORIDE

Application Number

90381

Product Number

2

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2010-07-07

Regulatory Status

RX

2015
28 Dec
RX Application: 207042

Drug Name

NEOSTIGMINE METHYLSULFATE

Product Number

1

Dosage Form

-

Strength

5MG/10ML (0.5MG/ML)

Approval Date

2015-12-28

207042 / 1

Active Ingredient

NEOSTIGMINE METHYLSULFATE

Application Number

207042

Product Number

1

Dosage Form

-

Strength

5MG/10ML (0.5MG/ML)

Approval Date

2015-12-28

Regulatory Status

RX

2015
28 Dec
RX Application: 207042

Drug Name

NEOSTIGMINE METHYLSULFATE

Product Number

2

Dosage Form

-

Strength

10MG/10ML (1MG/ML)

Approval Date

2015-12-28

207042 / 2

Active Ingredient

NEOSTIGMINE METHYLSULFATE

Application Number

207042

Product Number

2

Dosage Form

-

Strength

10MG/10ML (1MG/ML)

Approval Date

2015-12-28

Regulatory Status

RX

2022
13 Jul
Discontinued Application: 216206

Drug Name

NEOSTIGMINE METHYLSULFATE

Product Number

1

Dosage Form

-

Strength

3MG/3ML (1MG/ML)

Approval Date

2022-07-13

216206 / 1

Active Ingredient

NEOSTIGMINE METHYLSULFATE

Application Number

216206

Product Number

1

Dosage Form

-

Strength

3MG/3ML (1MG/ML)

Approval Date

2022-07-13

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83718

Drug Name

NIACIN

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

83718 / 1

Active Ingredient

NIACIN

Application Number

83718

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2008
24 Jul
RX Application: 22276

Drug Name

NICARDIPINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG/10ML (2.5MG/ML)

Approval Date

2008-07-24

22276 / 1

Active Ingredient

NICARDIPINE HYDROCHLORIDE

Application Number

22276

Product Number

1

Dosage Form

-

Strength

25MG/10ML (2.5MG/ML)

Approval Date

2008-07-24

Regulatory Status

RX

2009
28 Dec
Discontinued Application: 78714

Drug Name

NICARDIPINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG/10ML (2.5MG/ML)

Approval Date

2009-12-28

78714 / 1

Active Ingredient

NICARDIPINE HYDROCHLORIDE

Application Number

78714

Product Number

1

Dosage Form

-

Strength

25MG/10ML (2.5MG/ML)

Approval Date

2009-12-28

Regulatory Status

Discontinued

2016
07 Apr
RX Application: 22276

Drug Name

NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE

Product Number

2

Dosage Form

-

Strength

20MG/200ML (0.1MG/ML)

Approval Date

2016-04-07

22276 / 2

Active Ingredient

NICARDIPINE HYDROCHLORIDE

Application Number

22276

Product Number

2

Dosage Form

-

Strength

20MG/200ML (0.1MG/ML)

Approval Date

2016-04-07

Regulatory Status

RX

2016
07 Apr
RX Application: 22276

Drug Name

NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE

Product Number

3

Dosage Form

-

Strength

40MG/200ML (0.2MG/ML)

Approval Date

2016-04-07

22276 / 3

Active Ingredient

NICARDIPINE HYDROCHLORIDE

Application Number

22276

Product Number

3

Dosage Form

-

Strength

40MG/200ML (0.2MG/ML)

Approval Date

2016-04-07

Regulatory Status

RX

2003
31 Oct
RX Application: 40462

Drug Name

NOREPINEPHRINE BITARTRATE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2003-10-31

40462 / 1

Active Ingredient

NOREPINEPHRINE BITARTRATE

Application Number

40462

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2003-10-31

Regulatory Status

RX

2018
07 Nov
RX Application: 203662

Drug Name

NOREPINEPHRINE BITARTRATE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2018-11-07

203662 / 1

Active Ingredient

NOREPINEPHRINE BITARTRATE

Application Number

203662

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2018-11-07

Regulatory Status

RX

2008
17 Mar
Discontinued Application: 76616

Drug Name

OFLOXACIN

Product Number

1

Dosage Form

-

Strength

0.3%

Approval Date

2008-03-17

76616 / 1

Active Ingredient

OFLOXACIN

Application Number

76616

Product Number

1

Dosage Form

-

Strength

0.3%

Approval Date

2008-03-17

Regulatory Status

Discontinued

2017
16 Jun
Discontinued Application: 204866

Drug Name

OLANZAPINE

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2017-06-16

204866 / 1

Active Ingredient

OLANZAPINE

Application Number

204866

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2017-06-16

Regulatory Status

Discontinued

2017
16 Jun
Discontinued Application: 204866

Drug Name

OLANZAPINE

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2017-06-16

204866 / 2

Active Ingredient

OLANZAPINE

Application Number

204866

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2017-06-16

Regulatory Status

Discontinued

2017
16 Jun
Discontinued Application: 204866

Drug Name

OLANZAPINE

Product Number

3

Dosage Form

-

Strength

7.5MG

Approval Date

2017-06-16

204866 / 3

Active Ingredient

OLANZAPINE

Application Number

204866

Product Number

3

Dosage Form

-

Strength

7.5MG

Approval Date

2017-06-16

Regulatory Status

Discontinued

2017
16 Jun
Discontinued Application: 204866

Drug Name

OLANZAPINE

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2017-06-16

204866 / 4

Active Ingredient

OLANZAPINE

Application Number

204866

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2017-06-16

Regulatory Status

Discontinued

2017
16 Jun
Discontinued Application: 204866

Drug Name

OLANZAPINE

Product Number

5

Dosage Form

-

Strength

15MG

Approval Date

2017-06-16

204866 / 5

Active Ingredient

OLANZAPINE

Application Number

204866

Product Number

5

Dosage Form

-

Strength

15MG

Approval Date

2017-06-16

Regulatory Status

Discontinued

2017
16 Jun
Discontinued Application: 204866

Drug Name

OLANZAPINE

Product Number

6

Dosage Form

-

Strength

20MG

Approval Date

2017-06-16

204866 / 6

Active Ingredient

OLANZAPINE

Application Number

204866

Product Number

6

Dosage Form

-

Strength

20MG

Approval Date

2017-06-16

Regulatory Status

Discontinued

2020
19 Aug
Discontinued Application: 213757

Drug Name

OLOPATADINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.665MG/SPRAY

Approval Date

2020-08-19

213757 / 1

Active Ingredient

OLOPATADINE HYDROCHLORIDE

Application Number

213757

Product Number

1

Dosage Form

-

Strength

0.665MG/SPRAY

Approval Date

2020-08-19

Regulatory Status

Discontinued

2006
26 Dec
Discontinued Application: 76781

Drug Name

ONDANSETRON HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2006-12-26

76781 / 1

Active Ingredient

ONDANSETRON HYDROCHLORIDE

Application Number

76781

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2006-12-26

Regulatory Status

Discontinued

2006
26 Dec
RX Application: 76960

Drug Name

ONDANSETRON HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE/5ML

Approval Date

2006-12-26

76960 / 1

Active Ingredient

ONDANSETRON HYDROCHLORIDE

Application Number

76960

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE/5ML

Approval Date

2006-12-26

Regulatory Status

RX

2006
26 Dec
RX Application: 76967

Drug Name

ONDANSETRON HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2006-12-26

76967 / 1

Active Ingredient

ONDANSETRON HYDROCHLORIDE

Application Number

76967

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2006-12-26

Regulatory Status

RX

2006
26 Dec
RX Application: 77365

Drug Name

ONDANSETRON HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2006-12-26

77365 / 1

Active Ingredient

ONDANSETRON HYDROCHLORIDE

Application Number

77365

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2006-12-26

Regulatory Status

RX

2007
06 Sep
Discontinued Application: 77545

Drug Name

ONDANSETRON HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2007-09-06

77545 / 1

Active Ingredient

ONDANSETRON HYDROCHLORIDE

Application Number

77545

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2007-09-06

Regulatory Status

Discontinued

2007
06 Sep
Discontinued Application: 77545

Drug Name

ONDANSETRON HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 8MG BASE

Approval Date

2007-09-06

77545 / 2

Active Ingredient

ONDANSETRON HYDROCHLORIDE

Application Number

77545

Product Number

2

Dosage Form

-

Strength

EQ 8MG BASE

Approval Date

2007-09-06

Regulatory Status

Discontinued

2007
06 Sep
Discontinued Application: 77545

Drug Name

ONDANSETRON HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 24MG BASE

Approval Date

2007-09-06

77545 / 3

Active Ingredient

ONDANSETRON HYDROCHLORIDE

Application Number

77545

Product Number

3

Dosage Form

-

Strength

EQ 24MG BASE

Approval Date

2007-09-06

Regulatory Status

Discontinued

2006
26 Dec
Discontinued Application: 76780

Drug Name

ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2006-12-26

76780 / 1

Active Ingredient

ONDANSETRON HYDROCHLORIDE

Application Number

76780

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2006-12-26

Regulatory Status

Discontinued

2006
26 Dec
RX Application: 77011

Drug Name

ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2006-12-26

77011 / 1

Active Ingredient

ONDANSETRON HYDROCHLORIDE

Application Number

77011

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2006-12-26

Regulatory Status

RX

2006
26 Dec
RX Application: 77541

Drug Name

ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2006-12-26

77541 / 1

Active Ingredient

ONDANSETRON HYDROCHLORIDE

Application Number

77541

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2006-12-26

Regulatory Status

RX

2003
04 Mar
RX Application: 40463

Drug Name

ORPHENADRINE CITRATE

Product Number

1

Dosage Form

-

Strength

30MG/ML

Approval Date

2003-03-04

40463 / 1

Active Ingredient

ORPHENADRINE CITRATE

Application Number

40463

Product Number

1

Dosage Form

-

Strength

30MG/ML

Approval Date

2003-03-04

Regulatory Status

RX

2007
09 Oct
Discontinued Application: 77795

Drug Name

OXCARBAZEPINE

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2007-10-09

77795 / 1

Active Ingredient

OXCARBAZEPINE

Application Number

77795

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2007-10-09

Regulatory Status

Discontinued

2007
09 Oct
Discontinued Application: 77795

Drug Name

OXCARBAZEPINE

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2007-10-09

77795 / 2

Active Ingredient

OXCARBAZEPINE

Application Number

77795

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2007-10-09

Regulatory Status

Discontinued

2007
09 Oct
Discontinued Application: 77795

Drug Name

OXCARBAZEPINE

Product Number

3

Dosage Form

-

Strength

600MG

Approval Date

2007-10-09

77795 / 3

Active Ingredient

OXCARBAZEPINE

Application Number

77795

Product Number

3

Dosage Form

-

Strength

600MG

Approval Date

2007-10-09

Regulatory Status

Discontinued

2012
03 Oct
Discontinued Application: 201193

Drug Name

OXCARBAZEPINE

Product Number

1

Dosage Form

-

Strength

300MG/5ML

Approval Date

2012-10-03

201193 / 1

Active Ingredient

OXCARBAZEPINE

Application Number

201193

Product Number

1

Dosage Form

-

Strength

300MG/5ML

Approval Date

2012-10-03

Regulatory Status

Discontinued

2013
12 Jul
Discontinued Application: 203208

Drug Name

OXYCODONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG/5ML

Approval Date

2013-07-12

203208 / 1

Active Ingredient

OXYCODONE HYDROCHLORIDE

Application Number

203208

Product Number

1

Dosage Form

-

Strength

100MG/5ML

Approval Date

2013-07-12

Regulatory Status

Discontinued

2013
15 Jul
RX Application: 204037

Drug Name

OXYCODONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG/5ML

Approval Date

2013-07-15

204037 / 1

Active Ingredient

OXYCODONE HYDROCHLORIDE

Application Number

204037

Product Number

1

Dosage Form

-

Strength

5MG/5ML

Approval Date

2013-07-15

Regulatory Status

RX

2017
07 Aug
Discontinued Application: 208795

Drug Name

OXYCODONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG/5ML

Approval Date

2017-08-07

208795 / 1

Active Ingredient

OXYCODONE HYDROCHLORIDE

Application Number

208795

Product Number

1

Dosage Form

-

Strength

100MG/5ML

Approval Date

2017-08-07

Regulatory Status

Discontinued

2017
10 Aug
Discontinued Application: 208817

Drug Name

OXYCODONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG/5ML

Approval Date

2017-08-10

208817 / 1

Active Ingredient

OXYCODONE HYDROCHLORIDE

Application Number

208817

Product Number

1

Dosage Form

-

Strength

5MG/5ML

Approval Date

2017-08-10

Regulatory Status

Discontinued

2010
27 Sep
RX Application: 90964

Drug Name

OXYMORPHONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2010-09-27

90964 / 1

Active Ingredient

OXYMORPHONE HYDROCHLORIDE

Application Number

90964

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2010-09-27

Regulatory Status

RX

2010
27 Sep
RX Application: 90964

Drug Name

OXYMORPHONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2010-09-27

90964 / 2

Active Ingredient

OXYMORPHONE HYDROCHLORIDE

Application Number

90964

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2010-09-27

Regulatory Status

RX

2013
15 Jul
Discontinued Application: 200822

Drug Name

OXYMORPHONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2013-07-15

200822 / 1

Active Ingredient

OXYMORPHONE HYDROCHLORIDE

Application Number

200822

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2013-07-15

Regulatory Status

Discontinued

2013
15 Jul
Discontinued Application: 200822

Drug Name

OXYMORPHONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2013-07-15

200822 / 2

Active Ingredient

OXYMORPHONE HYDROCHLORIDE

Application Number

200822

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2013-07-15

Regulatory Status

Discontinued

2013
15 Jul
Discontinued Application: 200822

Drug Name

OXYMORPHONE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

7.5MG

Approval Date

2013-07-15

200822 / 3

Active Ingredient

OXYMORPHONE HYDROCHLORIDE

Application Number

200822

Product Number

3

Dosage Form

-

Strength

7.5MG

Approval Date

2013-07-15

Regulatory Status

Discontinued

2013
15 Jul
Discontinued Application: 200822

Drug Name

OXYMORPHONE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2013-07-15

200822 / 4

Active Ingredient

OXYMORPHONE HYDROCHLORIDE

Application Number

200822

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2013-07-15

Regulatory Status

Discontinued

2013
15 Jul
Discontinued Application: 200822

Drug Name

OXYMORPHONE HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

15MG

Approval Date

2013-07-15

200822 / 5

Active Ingredient

OXYMORPHONE HYDROCHLORIDE

Application Number

200822

Product Number

5

Dosage Form

-

Strength

15MG

Approval Date

2013-07-15

Regulatory Status

Discontinued

2013
15 Jul
Discontinued Application: 200822

Drug Name

OXYMORPHONE HYDROCHLORIDE

Product Number

6

Dosage Form

-

Strength

20MG

Approval Date

2013-07-15

200822 / 6

Active Ingredient

OXYMORPHONE HYDROCHLORIDE

Application Number

200822

Product Number

6

Dosage Form

-

Strength

20MG

Approval Date

2013-07-15

Regulatory Status

Discontinued

2013
15 Jul
Discontinued Application: 200822

Drug Name

OXYMORPHONE HYDROCHLORIDE

Product Number

7

Dosage Form

-

Strength

30MG

Approval Date

2013-07-15

200822 / 7

Active Ingredient

OXYMORPHONE HYDROCHLORIDE

Application Number

200822

Product Number

7

Dosage Form

-

Strength

30MG

Approval Date

2013-07-15

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 60770

Drug Name

OXYTETRACYCLINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1982-01-01

60770 / 1

Active Ingredient

OXYTETRACYCLINE HYDROCHLORIDE

Application Number

60770

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
RX Application: 18243

Drug Name

OXYTOCIN

Product Number

1

Dosage Form

-

Strength

10USP UNITS/ML (10USP UNITS/ML)

Approval Date

1982-01-01

18243 / 1

Active Ingredient

OXYTOCIN

Application Number

18243

Product Number

1

Dosage Form

-

Strength

10USP UNITS/ML (10USP UNITS/ML)

Approval Date

1982-01-01

Regulatory Status

RX

2007
10 Jan
RX Application: 18243

Drug Name

OXYTOCIN

Product Number

2

Dosage Form

-

Strength

100USP UNITS/10ML (10USP UNITS/ML)

Approval Date

2007-01-10

18243 / 2

Active Ingredient

OXYTOCIN

Application Number

18243

Product Number

2

Dosage Form

-

Strength

100USP UNITS/10ML (10USP UNITS/ML)

Approval Date

2007-01-10

Regulatory Status

RX

2013
13 Feb
RX Application: 200219

Drug Name

OXYTOCIN

Product Number

1

Dosage Form

-

Strength

10USP UNITS/ML (10USP UNITS/ML)

Approval Date

2013-02-13

200219 / 1

Active Ingredient

OXYTOCIN

Application Number

200219

Product Number

1

Dosage Form

-

Strength

10USP UNITS/ML (10USP UNITS/ML)

Approval Date

2013-02-13

Regulatory Status

RX

2002
28 Jan
RX Application: 75190

Drug Name

PACLITAXEL

Product Number

1

Dosage Form

-

Strength

6MG/ML

Approval Date

2002-01-28

75190 / 1

Active Ingredient

PACLITAXEL

Application Number

75190

Product Number

1

Dosage Form

-

Strength

6MG/ML

Approval Date

2002-01-28

Regulatory Status

RX

2016
22 Aug
Discontinued Application: 207963

Drug Name

PALONOSETRON HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 0.25MG BASE/2ML (EQ 0.125MG BASE/ML)

Approval Date

2016-08-22

207963 / 1

Active Ingredient

PALONOSETRON HYDROCHLORIDE

Application Number

207963

Product Number

1

Dosage Form

-

Strength

EQ 0.25MG BASE/2ML (EQ 0.125MG BASE/ML)

Approval Date

2016-08-22

Regulatory Status

Discontinued

2002
04 Mar
RX Application: 21113

Drug Name

PAMIDRONATE DISODIUM

Product Number

1

Dosage Form

-

Strength

30MG/10ML (3MG/ML)

Approval Date

2002-03-04

21113 / 1

Active Ingredient

PAMIDRONATE DISODIUM

Application Number

21113

Product Number

1

Dosage Form

-

Strength

30MG/10ML (3MG/ML)

Approval Date

2002-03-04

Regulatory Status

RX

2002
04 Mar
RX Application: 21113

Drug Name

PAMIDRONATE DISODIUM

Product Number

2

Dosage Form

-

Strength

90MG/10ML (9MG/ML)

Approval Date

2002-03-04

21113 / 2

Active Ingredient

PAMIDRONATE DISODIUM

Application Number

21113

Product Number

2

Dosage Form

-

Strength

90MG/10ML (9MG/ML)

Approval Date

2002-03-04

Regulatory Status

RX

2001
30 Apr
RX Application: 75290

Drug Name

PAMIDRONATE DISODIUM

Product Number

1

Dosage Form

-

Strength

30MG/VIAL

Approval Date

2001-04-30

75290 / 1

Active Ingredient

PAMIDRONATE DISODIUM

Application Number

75290

Product Number

1

Dosage Form

-

Strength

30MG/VIAL

Approval Date

2001-04-30

Regulatory Status

RX

2001
30 Apr
RX Application: 75290

Drug Name

PAMIDRONATE DISODIUM

Product Number

3

Dosage Form

-

Strength

90MG/VIAL

Approval Date

2001-04-30

75290 / 3

Active Ingredient

PAMIDRONATE DISODIUM

Application Number

75290

Product Number

3

Dosage Form

-

Strength

90MG/VIAL

Approval Date

2001-04-30

Regulatory Status

RX

2017
30 Jun
RX Application: 209463

Drug Name

PANTOPRAZOLE SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE/VIAL

Approval Date

2017-06-30

209463 / 1

Active Ingredient

PANTOPRAZOLE SODIUM

Application Number

209463

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE/VIAL

Approval Date

2017-06-30

Regulatory Status

RX

2014
18 Nov
Discontinued Application: 205917

Drug Name

PARICALCITOL

Product Number

1

Dosage Form

-

Strength

0.002MG/ML (0.002MG/ML)

Approval Date

2014-11-18

205917 / 1

Active Ingredient

PARICALCITOL

Application Number

205917

Product Number

1

Dosage Form

-

Strength

0.002MG/ML (0.002MG/ML)

Approval Date

2014-11-18

Regulatory Status

Discontinued

2014
18 Nov
Discontinued Application: 205917

Drug Name

PARICALCITOL

Product Number

2

Dosage Form

-

Strength

0.005MG/ML (0.005MG/ML)

Approval Date

2014-11-18

205917 / 2

Active Ingredient

PARICALCITOL

Application Number

205917

Product Number

2

Dosage Form

-

Strength

0.005MG/ML (0.005MG/ML)

Approval Date

2014-11-18

Regulatory Status

Discontinued

2014
18 Nov
Discontinued Application: 205917

Drug Name

PARICALCITOL

Product Number

3

Dosage Form

-

Strength

0.01MG/2ML (0.005MG/ML)

Approval Date

2014-11-18

205917 / 3

Active Ingredient

PARICALCITOL

Application Number

205917

Product Number

3

Dosage Form

-

Strength

0.01MG/2ML (0.005MG/ML)

Approval Date

2014-11-18

Regulatory Status

Discontinued

2013
11 Oct
RX Application: 90549

Drug Name

PENICILLIN V POTASSIUM

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2013-10-11

90549 / 1

Active Ingredient

PENICILLIN V POTASSIUM

Application Number

90549

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2013-10-11

Regulatory Status

RX

2013
11 Oct
RX Application: 90549

Drug Name

PENICILLIN V POTASSIUM

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2013-10-11

90549 / 2

Active Ingredient

PENICILLIN V POTASSIUM

Application Number

90549

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2013-10-11

Regulatory Status

RX

2017
13 Nov
RX Application: 203619

Drug Name

PENTOBARBITAL SODIUM

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

2017-11-13

203619 / 1

Active Ingredient

PENTOBARBITAL SODIUM

Application Number

203619

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

2017-11-13

Regulatory Status

RX

2009
10 Nov
Discontinued Application: 90072

Drug Name

PERINDOPRIL ERBUMINE

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2009-11-10

90072 / 1

Active Ingredient

PERINDOPRIL ERBUMINE

Application Number

90072

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2009-11-10

Regulatory Status

Discontinued

2009
10 Nov
Discontinued Application: 90072

Drug Name

PERINDOPRIL ERBUMINE

Product Number

2

Dosage Form

-

Strength

4MG

Approval Date

2009-11-10

90072 / 2

Active Ingredient

PERINDOPRIL ERBUMINE

Application Number

90072

Product Number

2

Dosage Form

-

Strength

4MG

Approval Date

2009-11-10

Regulatory Status

Discontinued

2009
10 Nov
Discontinued Application: 90072

Drug Name

PERINDOPRIL ERBUMINE

Product Number

3

Dosage Form

-

Strength

8MG

Approval Date

2009-11-10

90072 / 3

Active Ingredient

PERINDOPRIL ERBUMINE

Application Number

90072

Product Number

3

Dosage Form

-

Strength

8MG

Approval Date

2009-11-10

Regulatory Status

Discontinued

2012
16 Jul
Discontinued Application: 201050

Drug Name

PHENOXYBENZAMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2012-07-16

201050 / 1

Active Ingredient

PHENOXYBENZAMINE HYDROCHLORIDE

Application Number

201050

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2012-07-16

Regulatory Status

Discontinued

1998
11 Mar
RX Application: 40235

Drug Name

PHENTOLAMINE MESYLATE

Product Number

1

Dosage Form

-

Strength

5MG/VIAL

Approval Date

1998-03-11

40235 / 1

Active Ingredient

PHENTOLAMINE MESYLATE

Application Number

40235

Product Number

1

Dosage Form

-

Strength

5MG/VIAL

Approval Date

1998-03-11

Regulatory Status

RX

2012
20 Dec
RX Application: 203826

Drug Name

PHENYLEPHRINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG/ML (10MG/ML)

Approval Date

2012-12-20

203826 / 1

Active Ingredient

PHENYLEPHRINE HYDROCHLORIDE

Application Number

203826

Product Number

1

Dosage Form

-

Strength

10MG/ML (10MG/ML)

Approval Date

2012-12-20

Regulatory Status

RX

2019
19 Jun
RX Application: 203826

Drug Name

PHENYLEPHRINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

50MG/5ML (10MG/ML)

Approval Date

2019-06-19

203826 / 2

Active Ingredient

PHENYLEPHRINE HYDROCHLORIDE

Application Number

203826

Product Number

2

Dosage Form

-

Strength

50MG/5ML (10MG/ML)

Approval Date

2019-06-19

Regulatory Status

RX

2019
19 Jun
RX Application: 203826

Drug Name

PHENYLEPHRINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

100MG/10ML (10MG/ML)

Approval Date

2019-06-19

203826 / 3

Active Ingredient

PHENYLEPHRINE HYDROCHLORIDE

Application Number

203826

Product Number

3

Dosage Form

-

Strength

100MG/10ML (10MG/ML)

Approval Date

2019-06-19

Regulatory Status

RX

2014
23 Dec
Discontinued Application: 40675

Drug Name

PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG/5ML;6.25MG/5ML

Approval Date

2014-12-23

40675 / 1

Active Ingredient

PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE

Application Number

40675

Product Number

1

Dosage Form

-

Strength

5MG/5ML;6.25MG/5ML

Approval Date

2014-12-23

Regulatory Status

Discontinued

1982
01 Jan
RX Application: 84307

Drug Name

PHENYTOIN SODIUM

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

1982-01-01

84307 / 1

Active Ingredient

PHENYTOIN SODIUM

Application Number

84307

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

1982-01-01

Regulatory Status

RX

2024
19 Dec
Discontinued Application: 212112

Drug Name

PHYTONADIONE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2024-12-19

212112 / 1

Active Ingredient

PHYTONADIONE

Application Number

212112

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2024-12-19

Regulatory Status

Discontinued

2017
11 Aug
Discontinued Application: 209256

Drug Name

PIROXICAM

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2017-08-11

209256 / 1

Active Ingredient

PIROXICAM

Application Number

209256

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2017-08-11

Regulatory Status

Discontinued

2017
11 Aug
Discontinued Application: 209256

Drug Name

PIROXICAM

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2017-08-11

209256 / 2

Active Ingredient

PIROXICAM

Application Number

209256

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2017-08-11

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 60716

Drug Name

POLYMYXIN B SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 500,000 UNITS BASE/VIAL

Approval Date

1982-01-01

60716 / 1

Active Ingredient

POLYMYXIN B SULFATE

Application Number

60716

Product Number

1

Dosage Form

-

Strength

EQ 500,000 UNITS BASE/VIAL

Approval Date

1982-01-01

Regulatory Status

Discontinued

2020
15 May
RX Application: 208773

Drug Name

POSACONAZOLE

Product Number

1

Dosage Form

-

Strength

40MG/ML

Approval Date

2020-05-15

208773 / 1

Active Ingredient

POSACONAZOLE

Application Number

208773

Product Number

1

Dosage Form

-

Strength

40MG/ML

Approval Date

2020-05-15

Regulatory Status

RX

2003
27 Feb
Discontinued Application: 40401

Drug Name

PREDNISOLONE

Product Number

1

Dosage Form

-

Strength

15MG/5ML

Approval Date

2003-02-27

40401 / 1

Active Ingredient

PREDNISOLONE

Application Number

40401

Product Number

1

Dosage Form

-

Strength

15MG/5ML

Approval Date

2003-02-27

Regulatory Status

Discontinued

2003
26 Mar
Discontinued Application: 75183

Drug Name

PREDNISOLONE SODIUM PHOSPHATE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/5ML

Approval Date

2003-03-26

75183 / 1

Active Ingredient

PREDNISOLONE SODIUM PHOSPHATE

Application Number

75183

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/5ML

Approval Date

2003-03-26

Regulatory Status

Discontinued

2004
08 Jan
Discontinued Application: 40538

Drug Name

PREDNISONE

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2004-01-08

40538 / 1

Active Ingredient

PREDNISONE

Application Number

40538

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2004-01-08

Regulatory Status

Discontinued

2010
01 Nov
Discontinued Application: 40890

Drug Name

PREDNISONE

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2010-11-01

40890 / 1

Active Ingredient

PREDNISONE

Application Number

40890

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2010-11-01

Regulatory Status

Discontinued

1982
01 Jan
RX Application: 80352

Drug Name

PREDNISONE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

80352 / 1

Active Ingredient

PREDNISONE

Application Number

80352

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

Regulatory Status

RX

1982
22 Apr
RX Application: 80352

Drug Name

PREDNISONE

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

1982-04-22

80352 / 2

Active Ingredient

PREDNISONE

Application Number

80352

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

1982-04-22

Regulatory Status

RX

1982
22 Apr
RX Application: 80352

Drug Name

PREDNISONE

Product Number

3

Dosage Form

-

Strength

2.5MG

Approval Date

1982-04-22

80352 / 3

Active Ingredient

PREDNISONE

Application Number

80352

Product Number

3

Dosage Form

-

Strength

2.5MG

Approval Date

1982-04-22

Regulatory Status

RX

1982
01 Jan
RX Application: 80352

Drug Name

PREDNISONE

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

80352 / 4

Active Ingredient

PREDNISONE

Application Number

80352

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 80352

Drug Name

PREDNISONE

Product Number

5

Dosage Form

-

Strength

20MG

Approval Date

1982-01-01

80352 / 5

Active Ingredient

PREDNISONE

Application Number

80352

Product Number

5

Dosage Form

-

Strength

20MG

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 80352

Drug Name

PREDNISONE

Product Number

6

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

80352 / 6

Active Ingredient

PREDNISONE

Application Number

80352

Product Number

6

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

Regulatory Status

RX

1984
01 Jun
Discontinued Application: 88465

Drug Name

PREDNISONE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1984-06-01

88465 / 1

Active Ingredient

PREDNISONE

Application Number

88465

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1984-06-01

Regulatory Status

Discontinued

1984
08 Nov
RX Application: 88703

Drug Name

PREDNISONE

Product Number

1

Dosage Form

-

Strength

5MG/5ML

Approval Date

1984-11-08

88703 / 1

Active Ingredient

PREDNISONE

Application Number

88703

Product Number

1

Dosage Form

-

Strength

5MG/5ML

Approval Date

1984-11-08

Regulatory Status

RX

1985
20 Feb
RX Application: 88810

Drug Name

PREDNISONE INTENSOL

Product Number

1

Dosage Form

-

Strength

5MG/ML

Approval Date

1985-02-20

88810 / 1

Active Ingredient

PREDNISONE

Application Number

88810

Product Number

1

Dosage Form

-

Strength

5MG/ML

Approval Date

1985-02-20

Regulatory Status

RX

2006
27 Jul
Discontinued Application: 40667

Drug Name

PRIMIDONE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2006-07-27

40667 / 1

Active Ingredient

PRIMIDONE

Application Number

40667

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2006-07-27

Regulatory Status

Discontinued

2006
27 Jul
Discontinued Application: 40667

Drug Name

PRIMIDONE

Product Number

2

Dosage Form

-

Strength

250MG

Approval Date

2006-07-27

40667 / 2

Active Ingredient

PRIMIDONE

Application Number

40667

Product Number

2

Dosage Form

-

Strength

250MG

Approval Date

2006-07-27

Regulatory Status

Discontinued

1986
17 Apr
Discontinued Application: 89029

Drug Name

PROCAINAMIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

1986-04-17

89029 / 1

Active Ingredient

PROCAINAMIDE HYDROCHLORIDE

Application Number

89029

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

1986-04-17

Regulatory Status

Discontinued

1988
03 May
Discontinued Application: 89523

Drug Name

PROCHLORPERAZINE EDISYLATE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

1988-05-03

89523 / 1

Active Ingredient

PROCHLORPERAZINE EDISYLATE

Application Number

89523

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

1988-05-03

Regulatory Status

Discontinued

1989
29 Aug
RX Application: 89903

Drug Name

PROCHLORPERAZINE EDISYLATE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

1989-08-29

89903 / 1

Active Ingredient

PROCHLORPERAZINE EDISYLATE

Application Number

89903

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

1989-08-29

Regulatory Status

RX

2022
22 Nov
Discontinued Application: 213630

Drug Name

PROCHLORPERAZINE EDISYLATE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

2022-11-22

213630 / 1

Active Ingredient

PROCHLORPERAZINE EDISYLATE

Application Number

213630

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

2022-11-22

Regulatory Status

Discontinued

2010
28 Oct
RX Application: 91033

Drug Name

PROGESTERONE

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

2010-10-28

91033 / 1

Active Ingredient

PROGESTERONE

Application Number

91033

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

2010-10-28

Regulatory Status

RX

1982
01 Jan
RX Application: 83312

Drug Name

PROMETHAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG/ML

Approval Date

1982-01-01

83312 / 1

Active Ingredient

PROMETHAZINE HYDROCHLORIDE

Application Number

83312

Product Number

1

Dosage Form

-

Strength

25MG/ML

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 83312

Drug Name

PROMETHAZINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

50MG/ML

Approval Date

1982-01-01

83312 / 2

Active Ingredient

PROMETHAZINE HYDROCHLORIDE

Application Number

83312

Product Number

2

Dosage Form

-

Strength

50MG/ML

Approval Date

1982-01-01

Regulatory Status

RX

1997
26 Aug
Discontinued Application: 40151

Drug Name

PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

10MG/5ML;6.25MG/5ML

Approval Date

1997-08-26

40151 / 1

Active Ingredient

CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE

Application Number

40151

Product Number

1

Dosage Form

-

Strength

10MG/5ML;6.25MG/5ML

Approval Date

1997-08-26

Regulatory Status

Discontinued

1996
31 Jul
Discontinued Application: 40027

Drug Name

PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE

Product Number

1

Dosage Form

-

Strength

15MG/5ML;6.25MG/5ML

Approval Date

1996-07-31

40027 / 1

Active Ingredient

DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE

Application Number

40027

Product Number

1

Dosage Form

-

Strength

15MG/5ML;6.25MG/5ML

Approval Date

1996-07-31

Regulatory Status

Discontinued

2014
23 Dec
Discontinued Application: 40674

Drug Name

PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

10MG/5ML;5MG/5ML;6.25MG/5ML

Approval Date

2014-12-23

40674 / 1

Active Ingredient

CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE

Application Number

40674

Product Number

1

Dosage Form

-

Strength

10MG/5ML;5MG/5ML;6.25MG/5ML

Approval Date

2014-12-23

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 80927

Drug Name

PROPANTHELINE BROMIDE

Product Number

1

Dosage Form

-

Strength

7.5MG

Approval Date

1982-01-01

80927 / 1

Active Ingredient

PROPANTHELINE BROMIDE

Application Number

80927

Product Number

1

Dosage Form

-

Strength

7.5MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 80927

Drug Name

PROPANTHELINE BROMIDE

Product Number

2

Dosage Form

-

Strength

15MG

Approval Date

1982-01-01

80927 / 2

Active Ingredient

PROPANTHELINE BROMIDE

Application Number

80927

Product Number

2

Dosage Form

-

Strength

15MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2005
19 Apr
RX Application: 74848

Drug Name

PROPOFOL

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2005-04-19

74848 / 1

Active Ingredient

PROPOFOL

Application Number

74848

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2005-04-19

Regulatory Status

RX

1987
15 May
RX Application: 70690

Drug Name

PROPRANOLOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

40MG/5ML

Approval Date

1987-05-15

70690 / 1

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

70690

Product Number

1

Dosage Form

-

Strength

40MG/5ML

Approval Date

1987-05-15

Regulatory Status

RX

1987
15 May
RX Application: 70690

Drug Name

PROPRANOLOL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

20MG/5ML

Approval Date

1987-05-15

70690 / 2

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

70690

Product Number

2

Dosage Form

-

Strength

20MG/5ML

Approval Date

1987-05-15

Regulatory Status

RX

2008
31 Jan
RX Application: 77760

Drug Name

PROPRANOLOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2008-01-31

77760 / 1

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

77760

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2008-01-31

Regulatory Status

RX

1986
05 Nov
Discontinued Application: 89474

Drug Name

PROTAMINE SULFATE

Product Number

1

Dosage Form

-

Strength

50MG/5ML (10MG/ML)

Approval Date

1986-11-05

89474 / 1

Active Ingredient

PROTAMINE SULFATE

Application Number

89474

Product Number

1

Dosage Form

-

Strength

50MG/5ML (10MG/ML)

Approval Date

1986-11-05

Regulatory Status

Discontinued

1986
05 Nov
Discontinued Application: 89475

Drug Name

PROTAMINE SULFATE

Product Number

1

Dosage Form

-

Strength

250MG/25ML (10MG/ML)

Approval Date

1986-11-05

89475 / 1

Active Ingredient

PROTAMINE SULFATE

Application Number

89475

Product Number

1

Dosage Form

-

Strength

250MG/25ML (10MG/ML)

Approval Date

1986-11-05

Regulatory Status

Discontinued

1988
07 Jun
Discontinued Application: 89475

Drug Name

PROTAMINE SULFATE

Product Number

2

Dosage Form

-

Strength

50MG/5ML (10MG/ML)

Approval Date

1988-06-07

89475 / 2

Active Ingredient

PROTAMINE SULFATE

Application Number

89475

Product Number

2

Dosage Form

-

Strength

50MG/5ML (10MG/ML)

Approval Date

1988-06-07

Regulatory Status

Discontinued

2008
16 Sep
Discontinued Application: 78913

Drug Name

PROTRIPTYLINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2008-09-16

78913 / 1

Active Ingredient

PROTRIPTYLINE HYDROCHLORIDE

Application Number

78913

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2008-09-16

Regulatory Status

Discontinued

2008
16 Sep
Discontinued Application: 78913

Drug Name

PROTRIPTYLINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2008-09-16

78913 / 2

Active Ingredient

PROTRIPTYLINE HYDROCHLORIDE

Application Number

78913

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2008-09-16

Regulatory Status

Discontinued

2025
24 Jun
RX Application: 217662

Drug Name

PRUCALOPRIDE SUCCINATE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2025-06-24

217662 / 1

Active Ingredient

PRUCALOPRIDE SUCCINATE

Application Number

217662

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2025-06-24

Regulatory Status

RX

2025
24 Jun
RX Application: 217662

Drug Name

PRUCALOPRIDE SUCCINATE

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2025-06-24

217662 / 2

Active Ingredient

PRUCALOPRIDE SUCCINATE

Application Number

217662

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2025-06-24

Regulatory Status

RX

1992
30 Jun
RX Application: 81319

Drug Name

PYRAZINAMIDE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1992-06-30

81319 / 1

Active Ingredient

PYRAZINAMIDE

Application Number

81319

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1992-06-30

Regulatory Status

RX

2012
27 Mar
RX Application: 90120

Drug Name

QUETIAPINE FUMARATE

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2012-03-27

90120 / 1

Active Ingredient

QUETIAPINE FUMARATE

Application Number

90120

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2012-03-27

Regulatory Status

RX

2012
27 Mar
RX Application: 90749

Drug Name

QUETIAPINE FUMARATE

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2012-03-27

90749 / 1

Active Ingredient

QUETIAPINE FUMARATE

Application Number

90749

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2012-03-27

Regulatory Status

RX

2012
27 Mar
RX Application: 90749

Drug Name

QUETIAPINE FUMARATE

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2012-03-27

90749 / 2

Active Ingredient

QUETIAPINE FUMARATE

Application Number

90749

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2012-03-27

Regulatory Status

RX

2012
27 Mar
RX Application: 90749

Drug Name

QUETIAPINE FUMARATE

Product Number

3

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2012-03-27

90749 / 3

Active Ingredient

QUETIAPINE FUMARATE

Application Number

90749

Product Number

3

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2012-03-27

Regulatory Status

RX

2012
27 Mar
RX Application: 90749

Drug Name

QUETIAPINE FUMARATE

Product Number

4

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

2012-03-27

90749 / 4

Active Ingredient

QUETIAPINE FUMARATE

Application Number

90749

Product Number

4

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

2012-03-27

Regulatory Status

RX

2012
27 Mar
RX Application: 90749

Drug Name

QUETIAPINE FUMARATE

Product Number

5

Dosage Form

-

Strength

EQ 400MG BASE

Approval Date

2012-03-27

90749 / 5

Active Ingredient

QUETIAPINE FUMARATE

Application Number

90749

Product Number

5

Dosage Form

-

Strength

EQ 400MG BASE

Approval Date

2012-03-27

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 83862

Drug Name

QUINIDINE SULFATE

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1982-01-01

83862 / 1

Active Ingredient

QUINIDINE SULFATE

Application Number

83862

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2008
18 Jun
RX Application: 77900

Drug Name

RAMIPRIL

Product Number

1

Dosage Form

-

Strength

1.25MG

Approval Date

2008-06-18

77900 / 1

Active Ingredient

RAMIPRIL

Application Number

77900

Product Number

1

Dosage Form

-

Strength

1.25MG

Approval Date

2008-06-18

Regulatory Status

RX

2008
18 Jun
RX Application: 77900

Drug Name

RAMIPRIL

Product Number

2

Dosage Form

-

Strength

2.5MG

Approval Date

2008-06-18

77900 / 2

Active Ingredient

RAMIPRIL

Application Number

77900

Product Number

2

Dosage Form

-

Strength

2.5MG

Approval Date

2008-06-18

Regulatory Status

RX

2008
18 Jun
RX Application: 77900

Drug Name

RAMIPRIL

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

2008-06-18

77900 / 3

Active Ingredient

RAMIPRIL

Application Number

77900

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

2008-06-18

Regulatory Status

RX

2008
18 Jun
RX Application: 77900

Drug Name

RAMIPRIL

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2008-06-18

77900 / 4

Active Ingredient

RAMIPRIL

Application Number

77900

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2008-06-18

Regulatory Status

RX

2005
02 Mar
Discontinued Application: 74777

Drug Name

RANITIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE/ML

Approval Date

2005-03-02

74777 / 1

Active Ingredient

RANITIDINE HYDROCHLORIDE

Application Number

74777

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE/ML

Approval Date

2005-03-02

Regulatory Status

Discontinued

2006
16 Feb
Discontinued Application: 77458

Drug Name

RANITIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE/ML

Approval Date

2006-02-16

77458 / 1

Active Ingredient

RANITIDINE HYDROCHLORIDE

Application Number

77458

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE/ML

Approval Date

2006-02-16

Regulatory Status

Discontinued

2023
02 Feb
RX Application: 215827

Drug Name

REGADENOSON

Product Number

1

Dosage Form

-

Strength

0.4MG/5ML (0.08MG/ML)

Approval Date

2023-02-02

215827 / 1

Active Ingredient

REGADENOSON

Application Number

215827

Product Number

1

Dosage Form

-

Strength

0.4MG/5ML (0.08MG/ML)

Approval Date

2023-02-02

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 17862

Drug Name

REGLAN

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

17862 / 1

Active Ingredient

METOCLOPRAMIDE HYDROCHLORIDE

Application Number

17862

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1987
28 May
Discontinued Application: 17862

Drug Name

REGLAN

Product Number

4

Dosage Form

-

Strength

EQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1987-05-28

17862 / 4

Active Ingredient

METOCLOPRAMIDE HYDROCHLORIDE

Application Number

17862

Product Number

4

Dosage Form

-

Strength

EQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1987-05-28

Regulatory Status

Discontinued

2020
13 Oct
RX Application: 210594

Drug Name

REMIFENTANIL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/VIAL

Approval Date

2020-10-13

210594 / 1

Active Ingredient

REMIFENTANIL HYDROCHLORIDE

Application Number

210594

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/VIAL

Approval Date

2020-10-13

Regulatory Status

RX

2020
13 Oct
RX Application: 210594

Drug Name

REMIFENTANIL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE/VIAL

Approval Date

2020-10-13

210594 / 2

Active Ingredient

REMIFENTANIL HYDROCHLORIDE

Application Number

210594

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE/VIAL

Approval Date

2020-10-13

Regulatory Status

RX

2020
13 Oct
RX Application: 210594

Drug Name

REMIFENTANIL HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 5MG BASE/VIAL

Approval Date

2020-10-13

210594 / 3

Active Ingredient

REMIFENTANIL HYDROCHLORIDE

Application Number

210594

Product Number

3

Dosage Form

-

Strength

EQ 5MG BASE/VIAL

Approval Date

2020-10-13

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 80975

Drug Name

RESERPINE

Product Number

1

Dosage Form

-

Strength

0.1MG

Approval Date

1982-01-01

80975 / 1

Active Ingredient

RESERPINE

Application Number

80975

Product Number

1

Dosage Form

-

Strength

0.1MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 80975

Drug Name

RESERPINE

Product Number

2

Dosage Form

-

Strength

0.25MG

Approval Date

1982-01-01

80975 / 2

Active Ingredient

RESERPINE

Application Number

80975

Product Number

2

Dosage Form

-

Strength

0.25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 80975

Drug Name

RESERPINE

Product Number

3

Dosage Form

-

Strength

1MG

Approval Date

1982-01-01

80975 / 3

Active Ingredient

RESERPINE

Application Number

80975

Product Number

3

Dosage Form

-

Strength

1MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1995
17 Apr
Discontinued Application: 20459

Drug Name

REVEX

Product Number

1

Dosage Form

-

Strength

EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1995-04-17

20459 / 1

Active Ingredient

NALMEFENE HYDROCHLORIDE

Application Number

20459

Product Number

1

Dosage Form

-

Strength

EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1995-04-17

Regulatory Status

Discontinued

1995
17 Apr
Discontinued Application: 20459

Drug Name

REVEX

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE/2ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1995-04-17

20459 / 2

Active Ingredient

NALMEFENE HYDROCHLORIDE

Application Number

20459

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE/2ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1995-04-17

Regulatory Status

Discontinued

1999
29 Oct
RX Application: 64217

Drug Name

RIFAMPIN

Product Number

1

Dosage Form

-

Strength

600MG/VIAL

Approval Date

1999-10-29

64217 / 1

Active Ingredient

RIFAMPIN

Application Number

64217

Product Number

1

Dosage Form

-

Strength

600MG/VIAL

Approval Date

1999-10-29

Regulatory Status

RX

2001
14 Mar
Discontinued Application: 65028

Drug Name

RIFAMPIN

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2001-03-14

65028 / 1

Active Ingredient

RIFAMPIN

Application Number

65028

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2001-03-14

Regulatory Status

Discontinued

2001
14 Mar
Discontinued Application: 65028

Drug Name

RIFAMPIN

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2001-03-14

65028 / 2

Active Ingredient

RIFAMPIN

Application Number

65028

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2001-03-14

Regulatory Status

Discontinued

2016
03 Mar
RX Application: 205039

Drug Name

RIFAMPIN

Product Number

1

Dosage Form

-

Strength

600MG/VIAL

Approval Date

2016-03-03

205039 / 1

Active Ingredient

RIFAMPIN

Application Number

205039

Product Number

1

Dosage Form

-

Strength

600MG/VIAL

Approval Date

2016-03-03

Regulatory Status

RX

2005
29 Jul
Discontinued Application: 65221

Drug Name

RIFAMPIN AND ISONIAZID

Product Number

1

Dosage Form

-

Strength

150MG;300MG

Approval Date

2005-07-29

65221 / 1

Active Ingredient

ISONIAZID; RIFAMPIN

Application Number

65221

Product Number

1

Dosage Form

-

Strength

150MG;300MG

Approval Date

2005-07-29

Regulatory Status

Discontinued

2009
29 Jul
Discontinued Application: 76904

Drug Name

RISPERIDONE

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2009-07-29

76904 / 1

Active Ingredient

RISPERIDONE

Application Number

76904

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2009-07-29

Regulatory Status

Discontinued

2020
03 Dec
Discontinued Application: 205801

Drug Name

RITONAVIR

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2020-12-03

205801 / 1

Active Ingredient

RITONAVIR

Application Number

205801

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2020-12-03

Regulatory Status

Discontinued

1982
01 Jan
RX Application: 11790

Drug Name

ROBAXIN

Product Number

1

Dosage Form

-

Strength

1GM/10ML (100MG/ML)

Approval Date

1982-01-01

11790 / 1

Active Ingredient

METHOCARBAMOL

Application Number

11790

Product Number

1

Dosage Form

-

Strength

1GM/10ML (100MG/ML)

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 17558

Drug Name

ROBINUL

Product Number

1

Dosage Form

-

Strength

0.2MG/ML

Approval Date

1982-01-01

17558 / 1

Active Ingredient

GLYCOPYRROLATE

Application Number

17558

Product Number

1

Dosage Form

-

Strength

0.2MG/ML

Approval Date

1982-01-01

Regulatory Status

RX

2023
24 May
Discontinued Application: 217034

Drug Name

ROCURONIUM BROMIDE

Product Number

1

Dosage Form

-

Strength

50MG/5ML (10MG/ML)

Approval Date

2023-05-24

217034 / 1

Active Ingredient

ROCURONIUM BROMIDE

Application Number

217034

Product Number

1

Dosage Form

-

Strength

50MG/5ML (10MG/ML)

Approval Date

2023-05-24

Regulatory Status

Discontinued

2008
05 May
Discontinued Application: 77852

Drug Name

ROPINIROLE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 0.25MG BASE

Approval Date

2008-05-05

77852 / 1

Active Ingredient

ROPINIROLE HYDROCHLORIDE

Application Number

77852

Product Number

1

Dosage Form

-

Strength

EQ 0.25MG BASE

Approval Date

2008-05-05

Regulatory Status

Discontinued

2008
05 May
Discontinued Application: 77852

Drug Name

ROPINIROLE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 0.5MG BASE

Approval Date

2008-05-05

77852 / 2

Active Ingredient

ROPINIROLE HYDROCHLORIDE

Application Number

77852

Product Number

2

Dosage Form

-

Strength

EQ 0.5MG BASE

Approval Date

2008-05-05

Regulatory Status

Discontinued

2008
05 May
Discontinued Application: 77852

Drug Name

ROPINIROLE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2008-05-05

77852 / 3

Active Ingredient

ROPINIROLE HYDROCHLORIDE

Application Number

77852

Product Number

3

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2008-05-05

Regulatory Status

Discontinued

2008
05 May
Discontinued Application: 77852

Drug Name

ROPINIROLE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2008-05-05

77852 / 4

Active Ingredient

ROPINIROLE HYDROCHLORIDE

Application Number

77852

Product Number

4

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2008-05-05

Regulatory Status

Discontinued

2008
05 May
Discontinued Application: 77852

Drug Name

ROPINIROLE HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

EQ 3MG BASE

Approval Date

2008-05-05

77852 / 5

Active Ingredient

ROPINIROLE HYDROCHLORIDE

Application Number

77852

Product Number

5

Dosage Form

-

Strength

EQ 3MG BASE

Approval Date

2008-05-05

Regulatory Status

Discontinued

2008
05 May
Discontinued Application: 77852

Drug Name

ROPINIROLE HYDROCHLORIDE

Product Number

6

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2008-05-05

77852 / 6

Active Ingredient

ROPINIROLE HYDROCHLORIDE

Application Number

77852

Product Number

6

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2008-05-05

Regulatory Status

Discontinued

2008
19 May
Discontinued Application: 77852

Drug Name

ROPINIROLE HYDROCHLORIDE

Product Number

7

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2008-05-19

77852 / 7

Active Ingredient

ROPINIROLE HYDROCHLORIDE

Application Number

77852

Product Number

7

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2008-05-19

Regulatory Status

Discontinued

2024
15 Aug
RX Application: 211907

Drug Name

ROPIVACAINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

200MG/100ML (2MG/ML)

Approval Date

2024-08-15

211907 / 1

Active Ingredient

ROPIVACAINE HYDROCHLORIDE

Application Number

211907

Product Number

1

Dosage Form

-

Strength

200MG/100ML (2MG/ML)

Approval Date

2024-08-15

Regulatory Status

RX

2024
15 Aug
RX Application: 211907

Drug Name

ROPIVACAINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

400MG/200ML (2MG/ML)

Approval Date

2024-08-15

211907 / 2

Active Ingredient

ROPIVACAINE HYDROCHLORIDE

Application Number

211907

Product Number

2

Dosage Form

-

Strength

400MG/200ML (2MG/ML)

Approval Date

2024-08-15

Regulatory Status

RX

2024
15 Aug
RX Application: 211907

Drug Name

ROPIVACAINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

500MG/100ML (5MG/ML)

Approval Date

2024-08-15

211907 / 3

Active Ingredient

ROPIVACAINE HYDROCHLORIDE

Application Number

211907

Product Number

3

Dosage Form

-

Strength

500MG/100ML (5MG/ML)

Approval Date

2024-08-15

Regulatory Status

RX

2020
20 Jul
RX Application: 214074

Drug Name

ROPIVACAINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

40MG/20ML (2MG/ML)

Approval Date

2020-07-20

214074 / 1

Active Ingredient

ROPIVACAINE HYDROCHLORIDE

Application Number

214074

Product Number

1

Dosage Form

-

Strength

40MG/20ML (2MG/ML)

Approval Date

2020-07-20

Regulatory Status

RX

2020
20 Jul
RX Application: 214074

Drug Name

ROPIVACAINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

150MG/30ML (5MG/ML)

Approval Date

2020-07-20

214074 / 2

Active Ingredient

ROPIVACAINE HYDROCHLORIDE

Application Number

214074

Product Number

2

Dosage Form

-

Strength

150MG/30ML (5MG/ML)

Approval Date

2020-07-20

Regulatory Status

RX

2020
20 Jul
RX Application: 214074

Drug Name

ROPIVACAINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

150MG/20ML (7.5MG/ML)

Approval Date

2020-07-20

214074 / 3

Active Ingredient

ROPIVACAINE HYDROCHLORIDE

Application Number

214074

Product Number

3

Dosage Form

-

Strength

150MG/20ML (7.5MG/ML)

Approval Date

2020-07-20

Regulatory Status

RX

2020
20 Jul
RX Application: 214074

Drug Name

ROPIVACAINE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

200MG/20ML (10MG/ML)

Approval Date

2020-07-20

214074 / 4

Active Ingredient

ROPIVACAINE HYDROCHLORIDE

Application Number

214074

Product Number

4

Dosage Form

-

Strength

200MG/20ML (10MG/ML)

Approval Date

2020-07-20

Regulatory Status

RX

-
Unclassified Application: 78658

Drug Name

ROSIGLITAZONE MALEATE

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

-

78658 / 1

Active Ingredient

ROSIGLITAZONE MALEATE

Application Number

78658

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 78658

Drug Name

ROSIGLITAZONE MALEATE

Product Number

2

Dosage Form

-

Strength

4MG

Approval Date

-

78658 / 2

Active Ingredient

ROSIGLITAZONE MALEATE

Application Number

78658

Product Number

2

Dosage Form

-

Strength

4MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 78658

Drug Name

ROSIGLITAZONE MALEATE

Product Number

3

Dosage Form

-

Strength

8MG

Approval Date

-

78658 / 3

Active Ingredient

ROSIGLITAZONE MALEATE

Application Number

78658

Product Number

3

Dosage Form

-

Strength

8MG

Approval Date

-

Regulatory Status

Unclassified

1982
01 Jan
Discontinued Application: 87003

Drug Name

ROXICET

Product Number

1

Dosage Form

-

Strength

325MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

87003 / 1

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Application Number

87003

Product Number

1

Dosage Form

-

Strength

325MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1986
03 Dec
Discontinued Application: 89351

Drug Name

ROXICET

Product Number

1

Dosage Form

-

Strength

325MG/5ML;5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1986-12-03

89351 / 1

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Application Number

89351

Product Number

1

Dosage Form

-

Strength

325MG/5ML;5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1986-12-03

Regulatory Status

Discontinued

2016
16 May
RX Application: 204988

Drug Name

RUFINAMIDE

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2016-05-16

204988 / 1

Active Ingredient

RUFINAMIDE

Application Number

204988

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2016-05-16

Regulatory Status

RX

2016
16 May
RX Application: 204988

Drug Name

RUFINAMIDE

Product Number

2

Dosage Form

-

Strength

400MG

Approval Date

2016-05-16

204988 / 2

Active Ingredient

RUFINAMIDE

Application Number

204988

Product Number

2

Dosage Form

-

Strength

400MG

Approval Date

2016-05-16

Regulatory Status

RX

2019
23 Apr
RX Application: 207363

Drug Name

RUFINAMIDE

Product Number

1

Dosage Form

-

Strength

40MG/ML

Approval Date

2019-04-23

207363 / 1

Active Ingredient

RUFINAMIDE

Application Number

207363

Product Number

1

Dosage Form

-

Strength

40MG/ML

Approval Date

2019-04-23

Regulatory Status

RX

2025
11 Jun
RX Application: 218797

Drug Name

SAPROPTERIN DIHYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2025-06-11

218797 / 1

Active Ingredient

SAPROPTERIN DIHYDROCHLORIDE

Application Number

218797

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2025-06-11

Regulatory Status

RX

2009
10 Aug
Discontinued Application: 77864

Drug Name

SERTRALINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2009-08-10

77864 / 1

Active Ingredient

SERTRALINE HYDROCHLORIDE

Application Number

77864

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2009-08-10

Regulatory Status

Discontinued

2009
10 Aug
Discontinued Application: 77864

Drug Name

SERTRALINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2009-08-10

77864 / 2

Active Ingredient

SERTRALINE HYDROCHLORIDE

Application Number

77864

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2009-08-10

Regulatory Status

Discontinued

2009
10 Aug
Discontinued Application: 77864

Drug Name

SERTRALINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2009-08-10

77864 / 3

Active Ingredient

SERTRALINE HYDROCHLORIDE

Application Number

77864

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2009-08-10

Regulatory Status

Discontinued

2024
15 Mar
RX Application: 216920

Drug Name

SODIUM ACETATE

Product Number

1

Dosage Form

-

Strength

40MEQ/20ML (2MEQ/ML)

Approval Date

2024-03-15

216920 / 1

Active Ingredient

SODIUM ACETATE

Application Number

216920

Product Number

1

Dosage Form

-

Strength

40MEQ/20ML (2MEQ/ML)

Approval Date

2024-03-15

Regulatory Status

RX

2024
15 Mar
RX Application: 216920

Drug Name

SODIUM ACETATE

Product Number

2

Dosage Form

-

Strength

100MEQ/50ML (2MEQ/ML)

Approval Date

2024-03-15

216920 / 2

Active Ingredient

SODIUM ACETATE

Application Number

216920

Product Number

2

Dosage Form

-

Strength

100MEQ/50ML (2MEQ/ML)

Approval Date

2024-03-15

Regulatory Status

RX

2024
15 Mar
RX Application: 216920

Drug Name

SODIUM ACETATE

Product Number

3

Dosage Form

-

Strength

200MEQ/100ML (2MEQ/ML)

Approval Date

2024-03-15

216920 / 3

Active Ingredient

SODIUM ACETATE

Application Number

216920

Product Number

3

Dosage Form

-

Strength

200MEQ/100ML (2MEQ/ML)

Approval Date

2024-03-15

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 85418

Drug Name

SODIUM BUTABARBITAL

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

1982-01-01

85418 / 1

Active Ingredient

BUTABARBITAL SODIUM

Application Number

85418

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85432

Drug Name

SODIUM BUTABARBITAL

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

1982-01-01

85432 / 1

Active Ingredient

BUTABARBITAL SODIUM

Application Number

85432

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2013
24 Sep
RX Application: 201833

Drug Name

SODIUM CHLORIDE 0.9%

Product Number

1

Dosage Form

-

Strength

18MG/2ML (9MG/ML)

Approval Date

2013-09-24

201833 / 1

Active Ingredient

SODIUM CHLORIDE

Application Number

201833

Product Number

1

Dosage Form

-

Strength

18MG/2ML (9MG/ML)

Approval Date

2013-09-24

Regulatory Status

RX

2015
07 Jan
RX Application: 201833

Drug Name

SODIUM CHLORIDE 0.9%

Product Number

2

Dosage Form

-

Strength

90MG/10ML (9MG/ML)

Approval Date

2015-01-07

201833 / 2

Active Ingredient

SODIUM CHLORIDE

Application Number

201833

Product Number

2

Dosage Form

-

Strength

90MG/10ML (9MG/ML)

Approval Date

2015-01-07

Regulatory Status

RX

2012
20 Jan
Discontinued Application: 201850

Drug Name

SODIUM CHLORIDE 0.9%

Product Number

1

Dosage Form

-

Strength

90MG/10ML (9MG/ML)

Approval Date

2012-01-20

201850 / 1

Active Ingredient

SODIUM CHLORIDE

Application Number

201850

Product Number

1

Dosage Form

-

Strength

90MG/10ML (9MG/ML)

Approval Date

2012-01-20

Regulatory Status

Discontinued

2011
31 Mar
RX Application: 78215

Drug Name

SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE

Product Number

1

Dosage Form

-

Strength

EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)

Approval Date

2011-03-31

78215 / 1

Active Ingredient

SODIUM FERRIC GLUCONATE COMPLEX

Application Number

78215

Product Number

1

Dosage Form

-

Strength

EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)

Approval Date

2011-03-31

Regulatory Status

RX

2017
17 Jan
Discontinued Application: 202090

Drug Name

SODIUM OXYBATE

Product Number

1

Dosage Form

-

Strength

0.5GM/ML

Approval Date

2017-01-17

202090 / 1

Active Ingredient

SODIUM OXYBATE

Application Number

202090

Product Number

1

Dosage Form

-

Strength

0.5GM/ML

Approval Date

2017-01-17

Regulatory Status

Discontinued

1986
17 Nov
Discontinued Application: 89049

Drug Name

SODIUM POLYSTYRENE SULFONATE

Product Number

1

Dosage Form

-

Strength

15GM/60ML

Approval Date

1986-11-17

89049 / 1

Active Ingredient

SODIUM POLYSTYRENE SULFONATE

Application Number

89049

Product Number

1

Dosage Form

-

Strength

15GM/60ML

Approval Date

1986-11-17

Regulatory Status

Discontinued

2019
09 Dec
RX Application: 209937

Drug Name

SODIUM TETRADECYL SULFATE

Product Number

1

Dosage Form

-

Strength

60MG/2ML (30MG/ML)

Approval Date

2019-12-09

209937 / 1

Active Ingredient

SODIUM TETRADECYL SULFATE

Application Number

209937

Product Number

1

Dosage Form

-

Strength

60MG/2ML (30MG/ML)

Approval Date

2019-12-09

Regulatory Status

RX

2026
17 Jun
RX Application: 218016

Drug Name

SOLRIAMFETOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2026-06-17

218016 / 1

Active Ingredient

SOLRIAMFETOL HYDROCHLORIDE

Application Number

218016

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2026-06-17

Regulatory Status

RX

2026
17 Jun
RX Application: 218016

Drug Name

SOLRIAMFETOL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2026-06-17

218016 / 2

Active Ingredient

SOLRIAMFETOL HYDROCHLORIDE

Application Number

218016

Product Number

2

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2026-06-17

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 10349

Drug Name

SPARINE

Product Number

6

Dosage Form

-

Strength

50MG/ML

Approval Date

1982-01-01

10349 / 6

Active Ingredient

PROMAZINE HYDROCHLORIDE

Application Number

10349

Product Number

6

Dosage Form

-

Strength

50MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 10349

Drug Name

SPARINE

Product Number

8

Dosage Form

-

Strength

25MG/ML

Approval Date

1982-01-01

10349 / 8

Active Ingredient

PROMAZINE HYDROCHLORIDE

Application Number

10349

Product Number

8

Dosage Form

-

Strength

25MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

2015
02 Sep
RX Application: 206369

Drug Name

STERILE WATER FOR INJECTION

Product Number

1

Dosage Form

-

Strength

100% (10ML)

Approval Date

2015-09-02

206369 / 1

Active Ingredient

STERILE WATER FOR INJECTION

Application Number

206369

Product Number

1

Dosage Form

-

Strength

100% (10ML)

Approval Date

2015-09-02

Regulatory Status

RX

2015
02 Sep
Discontinued Application: 206369

Drug Name

STERILE WATER FOR INJECTION

Product Number

2

Dosage Form

-

Strength

100% (20ML)

Approval Date

2015-09-02

206369 / 2

Active Ingredient

STERILE WATER FOR INJECTION

Application Number

206369

Product Number

2

Dosage Form

-

Strength

100% (20ML)

Approval Date

2015-09-02

Regulatory Status

Discontinued

2023
31 Jan
RX Application: 212735

Drug Name

STERILE WATER FOR INJECTION

Product Number

1

Dosage Form

-

Strength

100%

Approval Date

2023-01-31

212735 / 1

Active Ingredient

STERILE WATER FOR INJECTION

Application Number

212735

Product Number

1

Dosage Form

-

Strength

100%

Approval Date

2023-01-31

Regulatory Status

RX

2020
12 Jun
RX Application: 213229

Drug Name

SUCCINYLCHOLINE CHLORIDE

Product Number

1

Dosage Form

-

Strength

20MG/ML

Approval Date

2020-06-12

213229 / 1

Active Ingredient

SUCCINYLCHOLINE CHLORIDE

Application Number

213229

Product Number

1

Dosage Form

-

Strength

20MG/ML

Approval Date

2020-06-12

Regulatory Status

RX

2021
20 Aug
Discontinued Application: 215143

Drug Name

SUCCINYLCHOLINE CHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG/5ML (20MG/ML)

Approval Date

2021-08-20

215143 / 1

Active Ingredient

SUCCINYLCHOLINE CHLORIDE

Application Number

215143

Product Number

1

Dosage Form

-

Strength

100MG/5ML (20MG/ML)

Approval Date

2021-08-20

Regulatory Status

Discontinued

2024
23 Jul
Discontinued Application: 212769

Drug Name

SUCRALFATE

Product Number

1

Dosage Form

-

Strength

1GM/10ML

Approval Date

2024-07-23

212769 / 1

Active Ingredient

SUCRALFATE

Application Number

212769

Product Number

1

Dosage Form

-

Strength

1GM/10ML

Approval Date

2024-07-23

Regulatory Status

Discontinued

1995
15 Dec
Discontinued Application: 74413

Drug Name

SUFENTANIL CITRATE

Product Number

1

Dosage Form

-

Strength

EQ 0.05MG BASE/ML

Approval Date

1995-12-15

74413 / 1

Active Ingredient

SUFENTANIL CITRATE

Application Number

74413

Product Number

1

Dosage Form

-

Strength

EQ 0.05MG BASE/ML

Approval Date

1995-12-15

Regulatory Status

Discontinued

2026
28 Jul
RX Application: 218727

Drug Name

SUGAMMADEX SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE/2ML (EQ 100MG BASE/ML)

Approval Date

2026-07-28

218727 / 1

Active Ingredient

SUGAMMADEX SODIUM

Application Number

218727

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE/2ML (EQ 100MG BASE/ML)

Approval Date

2026-07-28

Regulatory Status

RX

2026
28 Jul
RX Application: 218728

Drug Name

SUGAMMADEX SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE/2ML (EQ 100MG BASE/ML)

Approval Date

2026-07-28

218728 / 1

Active Ingredient

SUGAMMADEX SODIUM

Application Number

218728

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE/2ML (EQ 100MG BASE/ML)

Approval Date

2026-07-28

Regulatory Status

RX

2026
28 Jul
RX Application: 218728

Drug Name

SUGAMMADEX SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/5ML (EQ 100MG BASE/ML)

Approval Date

2026-07-28

218728 / 2

Active Ingredient

SUGAMMADEX SODIUM

Application Number

218728

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/5ML (EQ 100MG BASE/ML)

Approval Date

2026-07-28

Regulatory Status

RX

1987
29 Dec
Discontinued Application: 70627

Drug Name

SULFAMETHOXAZOLE AND TRIMETHOPRIM

Product Number

1

Dosage Form

-

Strength

80MG/ML;16MG/ML

Approval Date

1987-12-29

70627 / 1

Active Ingredient

SULFAMETHOXAZOLE; TRIMETHOPRIM

Application Number

70627

Product Number

1

Dosage Form

-

Strength

80MG/ML;16MG/ML

Approval Date

1987-12-29

Regulatory Status

Discontinued

1987
29 Dec
Discontinued Application: 70628

Drug Name

SULFAMETHOXAZOLE AND TRIMETHOPRIM

Product Number

1

Dosage Form

-

Strength

80MG/ML;16MG/ML

Approval Date

1987-12-29

70628 / 1

Active Ingredient

SULFAMETHOXAZOLE; TRIMETHOPRIM

Application Number

70628

Product Number

1

Dosage Form

-

Strength

80MG/ML;16MG/ML

Approval Date

1987-12-29

Regulatory Status

Discontinued

1997
29 Dec
Discontinued Application: 74650

Drug Name

SULFAMETHOXAZOLE AND TRIMETHOPRIM

Product Number

1

Dosage Form

-

Strength

200MG/5ML;40MG/5ML

Approval Date

1997-12-29

74650 / 1

Active Ingredient

SULFAMETHOXAZOLE; TRIMETHOPRIM

Application Number

74650

Product Number

1

Dosage Form

-

Strength

200MG/5ML;40MG/5ML

Approval Date

1997-12-29

Regulatory Status

Discontinued

2013
21 May
Discontinued Application: 78298

Drug Name

SUMATRIPTAN SUCCINATE

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2013-05-21

78298 / 1

Active Ingredient

SUMATRIPTAN SUCCINATE

Application Number

78298

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2013-05-21

Regulatory Status

Discontinued

2013
21 May
Discontinued Application: 78298

Drug Name

SUMATRIPTAN SUCCINATE

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2013-05-21

78298 / 2

Active Ingredient

SUMATRIPTAN SUCCINATE

Application Number

78298

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2013-05-21

Regulatory Status

Discontinued

2013
21 May
Discontinued Application: 78298

Drug Name

SUMATRIPTAN SUCCINATE

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2013-05-21

78298 / 3

Active Ingredient

SUMATRIPTAN SUCCINATE

Application Number

78298

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2013-05-21

Regulatory Status

Discontinued

2009
06 Feb
RX Application: 79123

Drug Name

SUMATRIPTAN SUCCINATE

Product Number

1

Dosage Form

-

Strength

EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)

Approval Date

2009-02-06

79123 / 1

Active Ingredient

SUMATRIPTAN SUCCINATE

Application Number

79123

Product Number

1

Dosage Form

-

Strength

EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)

Approval Date

2009-02-06

Regulatory Status

RX

2013
16 Sep
RX Application: 200183

Drug Name

SUMATRIPTAN SUCCINATE

Product Number

1

Dosage Form

-

Strength

EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)

Approval Date

2013-09-16

200183 / 1

Active Ingredient

SUMATRIPTAN SUCCINATE

Application Number

200183

Product Number

1

Dosage Form

-

Strength

EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)

Approval Date

2013-09-16

Regulatory Status

RX

2026
10 Feb
Discontinued Application: 205057

Drug Name

TAPENTADOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2026-02-10

205057 / 1

Active Ingredient

TAPENTADOL HYDROCHLORIDE

Application Number

205057

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2026-02-10

Regulatory Status

Discontinued

2026
10 Feb
Discontinued Application: 205057

Drug Name

TAPENTADOL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2026-02-10

205057 / 2

Active Ingredient

TAPENTADOL HYDROCHLORIDE

Application Number

205057

Product Number

2

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2026-02-10

Regulatory Status

Discontinued

2026
10 Feb
Discontinued Application: 205057

Drug Name

TAPENTADOL HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2026-02-10

205057 / 3

Active Ingredient

TAPENTADOL HYDROCHLORIDE

Application Number

205057

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2026-02-10

Regulatory Status

Discontinued

2001
12 Apr
Discontinued Application: 75498

Drug Name

TERAZOSIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2001-04-12

75498 / 1

Active Ingredient

TERAZOSIN HYDROCHLORIDE

Application Number

75498

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2001-04-12

Regulatory Status

Discontinued

2001
12 Apr
Discontinued Application: 75498

Drug Name

TERAZOSIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2001-04-12

75498 / 2

Active Ingredient

TERAZOSIN HYDROCHLORIDE

Application Number

75498

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2001-04-12

Regulatory Status

Discontinued

2001
12 Apr
Discontinued Application: 75498

Drug Name

TERAZOSIN HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2001-04-12

75498 / 3

Active Ingredient

TERAZOSIN HYDROCHLORIDE

Application Number

75498

Product Number

3

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2001-04-12

Regulatory Status

Discontinued

2001
12 Apr
Discontinued Application: 75498

Drug Name

TERAZOSIN HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2001-04-12

75498 / 4

Active Ingredient

TERAZOSIN HYDROCHLORIDE

Application Number

75498

Product Number

4

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2001-04-12

Regulatory Status

Discontinued

2009
20 May
RX Application: 78630

Drug Name

TERBUTALINE SULFATE

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2009-05-20

78630 / 1

Active Ingredient

TERBUTALINE SULFATE

Application Number

78630

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2009-05-20

Regulatory Status

RX

2010
15 Jul
RX Application: 90387

Drug Name

TESTOSTERONE CYPIONATE

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2010-07-15

90387 / 1

Active Ingredient

TESTOSTERONE CYPIONATE

Application Number

90387

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2010-07-15

Regulatory Status

RX

2010
15 Jul
RX Application: 90387

Drug Name

TESTOSTERONE CYPIONATE

Product Number

2

Dosage Form

-

Strength

200MG/ML

Approval Date

2010-07-15

90387 / 2

Active Ingredient

TESTOSTERONE CYPIONATE

Application Number

90387

Product Number

2

Dosage Form

-

Strength

200MG/ML

Approval Date

2010-07-15

Regulatory Status

RX

2012
01 May
RX Application: 91244

Drug Name

TESTOSTERONE CYPIONATE

Product Number

1

Dosage Form

-

Strength

200MG/ML

Approval Date

2012-05-01

91244 / 1

Active Ingredient

TESTOSTERONE CYPIONATE

Application Number

91244

Product Number

1

Dosage Form

-

Strength

200MG/ML

Approval Date

2012-05-01

Regulatory Status

RX

2012
18 Sep
RX Application: 91120

Drug Name

TESTOSTERONE ENANTHATE

Product Number

1

Dosage Form

-

Strength

200MG/ML

Approval Date

2012-09-18

91120 / 1

Active Ingredient

TESTOSTERONE ENANTHATE

Application Number

91120

Product Number

1

Dosage Form

-

Strength

200MG/ML

Approval Date

2012-09-18

Regulatory Status

RX

-
Unclassified Application: 207583

Drug Name

TESTOSTERONE UNDECANOATE

Product Number

1

Dosage Form

-

Strength

750MG/3ML (250MG/ML)

Approval Date

-

207583 / 1

Active Ingredient

TESTOSTERONE UNDECANOATE

Application Number

207583

Product Number

1

Dosage Form

-

Strength

750MG/3ML (250MG/ML)

Approval Date

-

Regulatory Status

Unclassified

2019
08 Apr
Discontinued Application: 209739

Drug Name

TETRABENAZINE

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

2019-04-08

209739 / 1

Active Ingredient

TETRABENAZINE

Application Number

209739

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

2019-04-08

Regulatory Status

Discontinued

2019
08 Apr
Discontinued Application: 209739

Drug Name

TETRABENAZINE

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2019-04-08

209739 / 2

Active Ingredient

TETRABENAZINE

Application Number

209739

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2019-04-08

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 60768

Drug Name

TETRACYCLINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1982-01-01

60768 / 1

Active Ingredient

TETRACYCLINE HYDROCHLORIDE

Application Number

60768

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 60768

Drug Name

TETRACYCLINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

60768 / 2

Active Ingredient

TETRACYCLINE HYDROCHLORIDE

Application Number

60768

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2023
05 Sep
RX Application: 211755

Drug Name

THIOTEPA

Product Number

1

Dosage Form

-

Strength

100MG/VIAL

Approval Date

2023-09-05

211755 / 1

Active Ingredient

THIOTEPA

Application Number

211755

Product Number

1

Dosage Form

-

Strength

100MG/VIAL

Approval Date

2023-09-05

Regulatory Status

RX

1992
30 Jun
Discontinued Application: 73494

Drug Name

THIOTHIXENE HYDROCHLORIDE INTENSOL

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

1992-06-30

73494 / 1

Active Ingredient

THIOTHIXENE HYDROCHLORIDE

Application Number

73494

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

1992-06-30

Regulatory Status

Discontinued

2002
10 Sep
Discontinued Application: 75163

Drug Name

TIMOLOL MALEATE

Product Number

1

Dosage Form

-

Strength

EQ 0.5% BASE

Approval Date

2002-09-10

75163 / 1

Active Ingredient

TIMOLOL MALEATE

Application Number

75163

Product Number

1

Dosage Form

-

Strength

EQ 0.5% BASE

Approval Date

2002-09-10

Regulatory Status

Discontinued

2012
30 Apr
Discontinued Application: 201172

Drug Name

TINIDAZOLE

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2012-04-30

201172 / 1

Active Ingredient

TINIDAZOLE

Application Number

201172

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2012-04-30

Regulatory Status

Discontinued

2012
30 Apr
Discontinued Application: 201172

Drug Name

TINIDAZOLE

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2012-04-30

201172 / 2

Active Ingredient

TINIDAZOLE

Application Number

201172

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2012-04-30

Regulatory Status

Discontinued

2014
28 May
RX Application: 201422

Drug Name

TOBRAMYCIN

Product Number

1

Dosage Form

-

Strength

300MG/5ML

Approval Date

2014-05-28

201422 / 1

Active Ingredient

TOBRAMYCIN

Application Number

201422

Product Number

1

Dosage Form

-

Strength

300MG/5ML

Approval Date

2014-05-28

Regulatory Status

RX

1991
26 Apr
Discontinued Application: 63113

Drug Name

TOBRAMYCIN SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

1991-04-26

63113 / 1

Active Ingredient

TOBRAMYCIN SULFATE

Application Number

63113

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

1991-04-26

Regulatory Status

Discontinued

1991
26 Apr
RX Application: 63117

Drug Name

TOBRAMYCIN SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE/ML

Approval Date

1991-04-26

63117 / 1

Active Ingredient

TOBRAMYCIN SULFATE

Application Number

63117

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE/ML

Approval Date

1991-04-26

Regulatory Status

RX

1991
29 Jul
Discontinued Application: 63118

Drug Name

TOBRAMYCIN SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE/ML

Approval Date

1991-07-29

63118 / 1

Active Ingredient

TOBRAMYCIN SULFATE

Application Number

63118

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE/ML

Approval Date

1991-07-29

Regulatory Status

Discontinued

1991
27 Nov
Discontinued Application: 63127

Drug Name

TOBRAMYCIN SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE/ML

Approval Date

1991-11-27

63127 / 1

Active Ingredient

TOBRAMYCIN SULFATE

Application Number

63127

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE/ML

Approval Date

1991-11-27

Regulatory Status

Discontinued

1991
27 Nov
Discontinued Application: 63128

Drug Name

TOBRAMYCIN SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

1991-11-27

63128 / 1

Active Ingredient

TOBRAMYCIN SULFATE

Application Number

63128

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

1991-11-27

Regulatory Status

Discontinued

2023
25 Sep
RX Application: 216878

Drug Name

TOFACITINIB CITRATE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2023-09-25

216878 / 1

Active Ingredient

TOFACITINIB CITRATE

Application Number

216878

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2023-09-25

Regulatory Status

RX

2013
25 Nov
Discontinued Application: 91185

Drug Name

TOPIRAMATE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2013-11-25

91185 / 1

Active Ingredient

TOPIRAMATE

Application Number

91185

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2013-11-25

Regulatory Status

Discontinued

2013
25 Nov
Discontinued Application: 91185

Drug Name

TOPIRAMATE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2013-11-25

91185 / 2

Active Ingredient

TOPIRAMATE

Application Number

91185

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2013-11-25

Regulatory Status

Discontinued

2013
25 Nov
Discontinued Application: 91185

Drug Name

TOPIRAMATE

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2013-11-25

91185 / 3

Active Ingredient

TOPIRAMATE

Application Number

91185

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2013-11-25

Regulatory Status

Discontinued

2013
25 Nov
Discontinued Application: 91185

Drug Name

TOPIRAMATE

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2013-11-25

91185 / 4

Active Ingredient

TOPIRAMATE

Application Number

91185

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2013-11-25

Regulatory Status

Discontinued

2005
01 Mar
Discontinued Application: 76943

Drug Name

TORSEMIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2005-03-01

76943 / 1

Active Ingredient

TORSEMIDE

Application Number

76943

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2005-03-01

Regulatory Status

Discontinued

2005
01 Mar
Discontinued Application: 76943

Drug Name

TORSEMIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2005-03-01

76943 / 2

Active Ingredient

TORSEMIDE

Application Number

76943

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2005-03-01

Regulatory Status

Discontinued

2005
01 Mar
RX Application: 76943

Drug Name

TORSEMIDE

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2005-03-01

76943 / 3

Active Ingredient

TORSEMIDE

Application Number

76943

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2005-03-01

Regulatory Status

RX

2008
11 Jun
Discontinued Application: 78007

Drug Name

TORSEMIDE

Product Number

1

Dosage Form

-

Strength

20MG/2ML (10MG/ML)

Approval Date

2008-06-11

78007 / 1

Active Ingredient

TORSEMIDE

Application Number

78007

Product Number

1

Dosage Form

-

Strength

20MG/2ML (10MG/ML)

Approval Date

2008-06-11

Regulatory Status

Discontinued

2008
11 Jun
Discontinued Application: 78007

Drug Name

TORSEMIDE

Product Number

2

Dosage Form

-

Strength

50MG/5ML (10MG/ML)

Approval Date

2008-06-11

78007 / 2

Active Ingredient

TORSEMIDE

Application Number

78007

Product Number

2

Dosage Form

-

Strength

50MG/5ML (10MG/ML)

Approval Date

2008-06-11

Regulatory Status

Discontinued

2024
06 Aug
Discontinued Application: 219002

Drug Name

TRAMETINIB DIMETHYL SULFOXIDE

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG

Approval Date

2024-08-06

219002 / 1

Active Ingredient

TRAMETINIB DIMETHYL SULFOXIDE

Application Number

219002

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG

Approval Date

2024-08-06

Regulatory Status

Discontinued

2024
06 Aug
Discontinued Application: 219002

Drug Name

TRAMETINIB DIMETHYL SULFOXIDE

Product Number

2

Dosage Form

-

Strength

EQ 2MG

Approval Date

2024-08-06

219002 / 2

Active Ingredient

TRAMETINIB DIMETHYL SULFOXIDE

Application Number

219002

Product Number

2

Dosage Form

-

Strength

EQ 2MG

Approval Date

2024-08-06

Regulatory Status

Discontinued

2024
09 Dec
RX Application: 215254

Drug Name

TRIAMCINOLONE ACETONIDE

Product Number

1

Dosage Form

-

Strength

40MG/ML

Approval Date

2024-12-09

215254 / 1

Active Ingredient

TRIAMCINOLONE ACETONIDE

Application Number

215254

Product Number

1

Dosage Form

-

Strength

40MG/ML

Approval Date

2024-12-09

Regulatory Status

RX

1994
01 Jun
Discontinued Application: 74224

Drug Name

TRIAZOLAM

Product Number

1

Dosage Form

-

Strength

0.125MG

Approval Date

1994-06-01

74224 / 1

Active Ingredient

TRIAZOLAM

Application Number

74224

Product Number

1

Dosage Form

-

Strength

0.125MG

Approval Date

1994-06-01

Regulatory Status

Discontinued

1994
01 Jun
Discontinued Application: 74224

Drug Name

TRIAZOLAM

Product Number

2

Dosage Form

-

Strength

0.25MG

Approval Date

1994-06-01

74224 / 2

Active Ingredient

TRIAZOLAM

Application Number

74224

Product Number

2

Dosage Form

-

Strength

0.25MG

Approval Date

1994-06-01

Regulatory Status

Discontinued

2017
28 Jul
Discontinued Application: 205438

Drug Name

TRIFLURIDINE

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

2017-07-28

205438 / 1

Active Ingredient

TRIFLURIDINE

Application Number

205438

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

2017-07-28

Regulatory Status

Discontinued

2000
16 Feb
Discontinued Application: 40337

Drug Name

TRIHEXYPHENIDYL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2000-02-16

40337 / 1

Active Ingredient

TRIHEXYPHENIDYL HYDROCHLORIDE

Application Number

40337

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2000-02-16

Regulatory Status

Discontinued

2000
16 Feb
Discontinued Application: 40337

Drug Name

TRIHEXYPHENIDYL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2000-02-16

40337 / 2

Active Ingredient

TRIHEXYPHENIDYL HYDROCHLORIDE

Application Number

40337

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2000-02-16

Regulatory Status

Discontinued

2019
15 Feb
RX Application: 211962

Drug Name

TYZAVAN

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/100ML (EQ 5MG BASE/ML)

Approval Date

2019-02-15

211962 / 1

Active Ingredient

VANCOMYCIN HYDROCHLORIDE

Application Number

211962

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/100ML (EQ 5MG BASE/ML)

Approval Date

2019-02-15

Regulatory Status

RX

2019
15 Feb
RX Application: 211962

Drug Name

TYZAVAN

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE/200ML (EQ 5MG BASE/ML)

Approval Date

2019-02-15

211962 / 2

Active Ingredient

VANCOMYCIN HYDROCHLORIDE

Application Number

211962

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE/200ML (EQ 5MG BASE/ML)

Approval Date

2019-02-15

Regulatory Status

RX

2019
15 Feb
RX Application: 211962

Drug Name

TYZAVAN

Product Number

3

Dosage Form

-

Strength

EQ 1.5GM BASE/300ML (EQ 5MG BASE/ML)

Approval Date

2019-02-15

211962 / 3

Active Ingredient

VANCOMYCIN HYDROCHLORIDE

Application Number

211962

Product Number

3

Dosage Form

-

Strength

EQ 1.5GM BASE/300ML (EQ 5MG BASE/ML)

Approval Date

2019-02-15

Regulatory Status

RX

2019
15 Feb
RX Application: 211962

Drug Name

TYZAVAN

Product Number

4

Dosage Form

-

Strength

EQ 2GM BASE/400ML (EQ 5MG BASE/ML)

Approval Date

2019-02-15

211962 / 4

Active Ingredient

VANCOMYCIN HYDROCHLORIDE

Application Number

211962

Product Number

4

Dosage Form

-

Strength

EQ 2GM BASE/400ML (EQ 5MG BASE/ML)

Approval Date

2019-02-15

Regulatory Status

RX

2020
13 May
RX Application: 211962

Drug Name

TYZAVAN

Product Number

5

Dosage Form

-

Strength

EQ 750MG BASE/150ML (EQ 5MG BASE/ML)

Approval Date

2020-05-13

211962 / 5

Active Ingredient

VANCOMYCIN HYDROCHLORIDE

Application Number

211962

Product Number

5

Dosage Form

-

Strength

EQ 750MG BASE/150ML (EQ 5MG BASE/ML)

Approval Date

2020-05-13

Regulatory Status

RX

2020
13 May
RX Application: 211962

Drug Name

TYZAVAN

Product Number

6

Dosage Form

-

Strength

EQ 1.25GM BASE/250ML (EQ 5MG BASE/ML)

Approval Date

2020-05-13

211962 / 6

Active Ingredient

VANCOMYCIN HYDROCHLORIDE

Application Number

211962

Product Number

6

Dosage Form

-

Strength

EQ 1.25GM BASE/250ML (EQ 5MG BASE/ML)

Approval Date

2020-05-13

Regulatory Status

RX

2020
13 May
RX Application: 211962

Drug Name

TYZAVAN

Product Number

7

Dosage Form

-

Strength

EQ 1.75GM BASE/350ML (EQ 5MG BASE/ML)

Approval Date

2020-05-13

211962 / 7

Active Ingredient

VANCOMYCIN HYDROCHLORIDE

Application Number

211962

Product Number

7

Dosage Form

-

Strength

EQ 1.75GM BASE/350ML (EQ 5MG BASE/ML)

Approval Date

2020-05-13

Regulatory Status

RX

2010
24 May
Discontinued Application: 78656

Drug Name

VALACYCLOVIR HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2010-05-24

78656 / 1

Active Ingredient

VALACYCLOVIR HYDROCHLORIDE

Application Number

78656

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2010-05-24

Regulatory Status

Discontinued

2010
24 May
Discontinued Application: 78656

Drug Name

VALACYCLOVIR HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE

Approval Date

2010-05-24

78656 / 2

Active Ingredient

VALACYCLOVIR HYDROCHLORIDE

Application Number

78656

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE

Approval Date

2010-05-24

Regulatory Status

Discontinued

2010
17 Feb
RX Application: 78523

Drug Name

VALPROATE SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE/ML

Approval Date

2010-02-17

78523 / 1

Active Ingredient

VALPROATE SODIUM

Application Number

78523

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE/ML

Approval Date

2010-02-17

Regulatory Status

RX

1995
13 Jan
Discontinued Application: 74060

Drug Name

VALPROIC ACID

Product Number

1

Dosage Form

-

Strength

250MG/5ML

Approval Date

1995-01-13

74060 / 1

Active Ingredient

VALPROIC ACID

Application Number

74060

Product Number

1

Dosage Form

-

Strength

250MG/5ML

Approval Date

1995-01-13

Regulatory Status

Discontinued

2019
19 Apr
RX Application: 206430

Drug Name

VALRUBICIN

Product Number

1

Dosage Form

-

Strength

40MG/ML

Approval Date

2019-04-19

206430 / 1

Active Ingredient

VALRUBICIN

Application Number

206430

Product Number

1

Dosage Form

-

Strength

40MG/ML

Approval Date

2019-04-19

Regulatory Status

RX

1986
22 Jul
Discontinued Application: 62682

Drug Name

VANCOLED

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1986-07-22

62682 / 1

Active Ingredient

VANCOMYCIN HYDROCHLORIDE

Application Number

62682

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1986-07-22

Regulatory Status

Discontinued

1988
30 Mar
Discontinued Application: 62682

Drug Name

VANCOLED

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1988-03-30

62682 / 2

Active Ingredient

VANCOMYCIN HYDROCHLORIDE

Application Number

62682

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1988-03-30

Regulatory Status

Discontinued

1988
11 May
Discontinued Application: 62682

Drug Name

VANCOLED

Product Number

3

Dosage Form

-

Strength

EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1988-05-11

62682 / 3

Active Ingredient

VANCOMYCIN HYDROCHLORIDE

Application Number

62682

Product Number

3

Dosage Form

-

Strength

EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1988-05-11

Regulatory Status

Discontinued

1988
11 May
Discontinued Application: 62682

Drug Name

VANCOLED

Product Number

4

Dosage Form

-

Strength

EQ 5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1988-05-11

62682 / 4

Active Ingredient

VANCOMYCIN HYDROCHLORIDE

Application Number

62682

Product Number

4

Dosage Form

-

Strength

EQ 5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1988-05-11

Regulatory Status

Discontinued

1988
11 May
Discontinued Application: 62682

Drug Name

VANCOLED

Product Number

5

Dosage Form

-

Strength

EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1988-05-11

62682 / 5

Active Ingredient

VANCOMYCIN HYDROCHLORIDE

Application Number

62682

Product Number

5

Dosage Form

-

Strength

EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1988-05-11

Regulatory Status

Discontinued

2021
26 Aug
Discontinued Application: 213895

Drug Name

VANCOMYCIN

Product Number

1

Dosage Form

-

Strength

5GM/100ML (50MG/ML)

Approval Date

2021-08-26

213895 / 1

Active Ingredient

VANCOMYCIN

Application Number

213895

Product Number

1

Dosage Form

-

Strength

5GM/100ML (50MG/ML)

Approval Date

2021-08-26

Regulatory Status

Discontinued

1988
02 Aug
Discontinued Application: 62879

Drug Name

VANCOMYCIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1988-08-02

62879 / 1

Active Ingredient

VANCOMYCIN HYDROCHLORIDE

Application Number

62879

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1988-08-02

Regulatory Status

Discontinued

1988
02 Aug
Discontinued Application: 62879

Drug Name

VANCOMYCIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1988-08-02

62879 / 2

Active Ingredient

VANCOMYCIN HYDROCHLORIDE

Application Number

62879

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1988-08-02

Regulatory Status

Discontinued

2020
11 Aug
Discontinued Application: 203300

Drug Name

VANCOMYCIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2020-08-11

203300 / 1

Active Ingredient

VANCOMYCIN HYDROCHLORIDE

Application Number

203300

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2020-08-11

Regulatory Status

Discontinued

2020
11 Aug
RX Application: 203300

Drug Name

VANCOMYCIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2020-08-11

203300 / 2

Active Ingredient

VANCOMYCIN HYDROCHLORIDE

Application Number

203300

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2020-08-11

Regulatory Status

RX

2015
28 Dec
RX Application: 204107

Drug Name

VANCOMYCIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2015-12-28

204107 / 1

Active Ingredient

VANCOMYCIN HYDROCHLORIDE

Application Number

204107

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2015-12-28

Regulatory Status

RX

2015
28 Dec
RX Application: 204107

Drug Name

VANCOMYCIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2015-12-28

204107 / 2

Active Ingredient

VANCOMYCIN HYDROCHLORIDE

Application Number

204107

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2015-12-28

Regulatory Status

RX

2018
15 Oct
RX Application: 204360

Drug Name

VANCOMYCIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 5GM BASE/VIAL

Approval Date

2018-10-15

204360 / 1

Active Ingredient

VANCOMYCIN HYDROCHLORIDE

Application Number

204360

Product Number

1

Dosage Form

-

Strength

EQ 5GM BASE/VIAL

Approval Date

2018-10-15

Regulatory Status

RX

2018
15 Oct
RX Application: 204360

Drug Name

VANCOMYCIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 10GM BASE/VIAL

Approval Date

2018-10-15

204360 / 2

Active Ingredient

VANCOMYCIN HYDROCHLORIDE

Application Number

204360

Product Number

2

Dosage Form

-

Strength

EQ 10GM BASE/VIAL

Approval Date

2018-10-15

Regulatory Status

RX

2018
03 Oct
RX Application: 206616

Drug Name

VANCOMYCIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 750MG BASE/VIAL

Approval Date

2018-10-03

206616 / 1

Active Ingredient

VANCOMYCIN HYDROCHLORIDE

Application Number

206616

Product Number

1

Dosage Form

-

Strength

EQ 750MG BASE/VIAL

Approval Date

2018-10-03

Regulatory Status

RX

2023
29 Jun
RX Application: 217489

Drug Name

VANCOMYCIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 1.25GM BASE/VIAL

Approval Date

2023-06-29

217489 / 1

Active Ingredient

VANCOMYCIN HYDROCHLORIDE

Application Number

217489

Product Number

1

Dosage Form

-

Strength

EQ 1.25GM BASE/VIAL

Approval Date

2023-06-29

Regulatory Status

RX

2023
29 Jun
RX Application: 217489

Drug Name

VANCOMYCIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 1.5GM BASE/VIAL

Approval Date

2023-06-29

217489 / 2

Active Ingredient

VANCOMYCIN HYDROCHLORIDE

Application Number

217489

Product Number

2

Dosage Form

-

Strength

EQ 1.5GM BASE/VIAL

Approval Date

2023-06-29

Regulatory Status

RX

1999
23 Aug
Discontinued Application: 75218

Drug Name

VECURONIUM BROMIDE

Product Number

1

Dosage Form

-

Strength

10MG/VIAL

Approval Date

1999-08-23

75218 / 1

Active Ingredient

VECURONIUM BROMIDE

Application Number

75218

Product Number

1

Dosage Form

-

Strength

10MG/VIAL

Approval Date

1999-08-23

Regulatory Status

Discontinued

1999
23 Aug
Discontinued Application: 75218

Drug Name

VECURONIUM BROMIDE

Product Number

2

Dosage Form

-

Strength

20MG/VIAL

Approval Date

1999-08-23

75218 / 2

Active Ingredient

VECURONIUM BROMIDE

Application Number

75218

Product Number

2

Dosage Form

-

Strength

20MG/VIAL

Approval Date

1999-08-23

Regulatory Status

Discontinued

2000
13 Jun
RX Application: 75549

Drug Name

VECURONIUM BROMIDE

Product Number

1

Dosage Form

-

Strength

10MG/VIAL

Approval Date

2000-06-13

75549 / 1

Active Ingredient

VECURONIUM BROMIDE

Application Number

75549

Product Number

1

Dosage Form

-

Strength

10MG/VIAL

Approval Date

2000-06-13

Regulatory Status

RX

2000
13 Jun
RX Application: 75549

Drug Name

VECURONIUM BROMIDE

Product Number

2

Dosage Form

-

Strength

20MG/VIAL

Approval Date

2000-06-13

75549 / 2

Active Ingredient

VECURONIUM BROMIDE

Application Number

75549

Product Number

2

Dosage Form

-

Strength

20MG/VIAL

Approval Date

2000-06-13

Regulatory Status

RX

2019
30 Jul
RX Application: 203725

Drug Name

VECURONIUM BROMIDE

Product Number

1

Dosage Form

-

Strength

10MG/VIAL

Approval Date

2019-07-30

203725 / 1

Active Ingredient

VECURONIUM BROMIDE

Application Number

203725

Product Number

1

Dosage Form

-

Strength

10MG/VIAL

Approval Date

2019-07-30

Regulatory Status

RX

2019
30 Jul
RX Application: 203725

Drug Name

VECURONIUM BROMIDE

Product Number

2

Dosage Form

-

Strength

20MG/VIAL

Approval Date

2019-07-30

203725 / 2

Active Ingredient

VECURONIUM BROMIDE

Application Number

203725

Product Number

2

Dosage Form

-

Strength

20MG/VIAL

Approval Date

2019-07-30

Regulatory Status

RX

2022
29 Aug
RX Application: 213104

Drug Name

VIGABATRIN

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2022-08-29

213104 / 1

Active Ingredient

VIGABATRIN

Application Number

213104

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2022-08-29

Regulatory Status

RX

1987
09 Apr
RX Application: 89395

Drug Name

VINBLASTINE SULFATE

Product Number

1

Dosage Form

-

Strength

10MG/VIAL

Approval Date

1987-04-09

89395 / 1

Active Ingredient

VINBLASTINE SULFATE

Application Number

89395

Product Number

1

Dosage Form

-

Strength

10MG/VIAL

Approval Date

1987-04-09

Regulatory Status

RX

2003
10 Jun
RX Application: 75992

Drug Name

VINORELBINE TARTRATE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

2003-06-10

75992 / 1

Active Ingredient

VINORELBINE TARTRATE

Application Number

75992

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

2003-06-10

Regulatory Status

RX

2003
11 Dec
RX Application: 76461

Drug Name

VINORELBINE TARTRATE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

2003-12-11

76461 / 1

Active Ingredient

VINORELBINE TARTRATE

Application Number

76461

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

2003-12-11

Regulatory Status

RX

2017
09 Mar
RX Application: 208562

Drug Name

VORICONAZOLE

Product Number

1

Dosage Form

-

Strength

200MG/VIAL

Approval Date

2017-03-09

208562 / 1

Active Ingredient

VORICONAZOLE

Application Number

208562

Product Number

1

Dosage Form

-

Strength

200MG/VIAL

Approval Date

2017-03-09

Regulatory Status

RX

-
Unclassified Application: 208562

Drug Name

VORICONAZOLE

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

-

208562 / 2

Active Ingredient

VORICONAZOLE

Application Number

208562

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

-

Regulatory Status

Unclassified

1982
01 Jan
Discontinued Application: 12179

Drug Name

VOSOL

Product Number

1

Dosage Form

-

Strength

2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

12179 / 1

Active Ingredient

ACETIC ACID, GLACIAL

Application Number

12179

Product Number

1

Dosage Form

-

Strength

2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1999
25 Mar
Discontinued Application: 20837

Drug Name

XOPENEX

Product Number

1

Dosage Form

-

Strength

EQ 0.021% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1999-03-25

20837 / 1

Active Ingredient

LEVALBUTEROL HYDROCHLORIDE

Application Number

20837

Product Number

1

Dosage Form

-

Strength

EQ 0.021% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1999-03-25

Regulatory Status

Discontinued

1999
25 Mar
Discontinued Application: 20837

Drug Name

XOPENEX

Product Number

2

Dosage Form

-

Strength

EQ 0.042% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1999-03-25

20837 / 2

Active Ingredient

LEVALBUTEROL HYDROCHLORIDE

Application Number

20837

Product Number

2

Dosage Form

-

Strength

EQ 0.042% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1999-03-25

Regulatory Status

Discontinued

2002
30 Jan
Discontinued Application: 20837

Drug Name

XOPENEX

Product Number

3

Dosage Form

-

Strength

EQ 0.0103% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2002-01-30

20837 / 3

Active Ingredient

LEVALBUTEROL HYDROCHLORIDE

Application Number

20837

Product Number

3

Dosage Form

-

Strength

EQ 0.0103% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2002-01-30

Regulatory Status

Discontinued

2003
18 Jul
Discontinued Application: 20837

Drug Name

XOPENEX

Product Number

4

Dosage Form

-

Strength

EQ 0.25% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2003-07-18

20837 / 4

Active Ingredient

LEVALBUTEROL HYDROCHLORIDE

Application Number

20837

Product Number

4

Dosage Form

-

Strength

EQ 0.25% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2003-07-18

Regulatory Status

Discontinued

-
Unclassified Application: 761439

Drug Name

XTRENBO

Product Number

2

Dosage Form

-

Strength

120MG/1.7ML(70MG/ML)

Approval Date

-

761439 / 2

Active Ingredient

DENOSUMAB-QBDE

Application Number

761439

Product Number

2

Dosage Form

-

Strength

120MG/1.7ML(70MG/ML)

Approval Date

-

Regulatory Status

Unclassified

2008
06 Jun
RX Application: 77237

Drug Name

ZALEPLON

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2008-06-06

77237 / 1

Active Ingredient

ZALEPLON

Application Number

77237

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2008-06-06

Regulatory Status

RX

2008
06 Jun
RX Application: 77237

Drug Name

ZALEPLON

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2008-06-06

77237 / 2

Active Ingredient

ZALEPLON

Application Number

77237

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2008-06-06

Regulatory Status

RX

2008
25 Nov
Discontinued Application: 78147

Drug Name

ZALEPLON

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2008-11-25

78147 / 1

Active Ingredient

ZALEPLON

Application Number

78147

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2008-11-25

Regulatory Status

Discontinued

2008
25 Nov
Discontinued Application: 78147

Drug Name

ZALEPLON

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2008-11-25

78147 / 2

Active Ingredient

ZALEPLON

Application Number

78147

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2008-11-25

Regulatory Status

Discontinued

2005
19 Sep
Discontinued Application: 76844

Drug Name

ZIDOVUDINE

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

2005-09-19

76844 / 1

Active Ingredient

ZIDOVUDINE

Application Number

76844

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

2005-09-19

Regulatory Status

Discontinued

2013
03 Jun
RX Application: 202182

Drug Name

ZOLEDRONIC ACID

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE/5ML

Approval Date

2013-06-03

202182 / 1

Active Ingredient

ZOLEDRONIC ACID

Application Number

202182

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE/5ML

Approval Date

2013-06-03

Regulatory Status

RX

2008
30 Apr
Discontinued Application: 78129

Drug Name

ZOLPIDEM TARTRATE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2008-04-30

78129 / 1

Active Ingredient

ZOLPIDEM TARTRATE

Application Number

78129

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2008-04-30

Regulatory Status

Discontinued

2008
30 Apr
Discontinued Application: 78129

Drug Name

ZOLPIDEM TARTRATE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2008-04-30

78129 / 2

Active Ingredient

ZOLPIDEM TARTRATE

Application Number

78129

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2008-04-30

Regulatory Status

Discontinued

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Drug Status Breakdown
1144 total
  • RX
  • Discontinued
  • Unclassified
  • OTC
Official Source

FDA approved drug data is based on publicly available U.S. Food and Drug Administration Orange Book information.

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FDA Approved Drug Record Details Preview

Explore important FDA approved drug information available in the records above.

Drug Name

ABIRATERONE ACETATE

Application Number

208339

Product Number

1

Active Ingredient

ABIRATERONE ACETATE

Dosage Form

-

Strength

250MG

FDA Approved Drug Data

Approved drug product information

Regular Updates

Data maintained from official sources

Structured Database

Searchable pharmaceutical data

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Organized FDA drug records

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