Hikma Pharmaceuticals Discontinued
FDA Approved Drugs

Hikma Pharmaceuticals Discontinued

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.

Discontinued
  • Total Records 529
  • Latest Approval Date Feb 10, 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 Discontinued

Country

United Kingdom

Social Profiles

LinkedIn X / Twitter
Company Snapshot

Hikma Pharmaceuticals Discontinued

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

United Kingdom

www.hikma.com/home/ Sarrar@hikma.com View on Map
FDA Approved Drug Records ( 529 records )
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
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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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
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

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
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

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

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

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

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

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

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

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

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

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

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
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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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
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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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
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

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

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

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

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

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

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
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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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
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

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

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

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

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

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

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
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

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

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

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

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

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

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

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

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

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

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

Related Databases
  • FDA Inspections
    0 View
  • EDQM CEP
    1 View
  • KDMF
    0 View
  • Japan DMF
    0 View
  • Eudra GMP
    0 View
  • NDC Database
    2 View
  • FDA Approved Drugs Database
    1,144 View
  • Drug Prices in Switzerland
    0 View
Drug Status Breakdown
529 total
  • Discontinued
Official Source

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

Visit FDA Orange Book
FDA Approved Drug Record Details Preview

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

Drug Name

ACYCLOVIR

Application Number

77026

Product Number

1

Active Ingredient

ACYCLOVIR

Dosage Form

-

Strength

200MG/5ML

FDA Approved Drug Data

Approved drug product information

Regular Updates

Data maintained from official sources

Structured Database

Searchable pharmaceutical data

Reliable Data

Organized FDA drug records

Create a New Buying Request

Fields marked with * are mandatory.

Please enter quantity.
Please select a unit.
Please select quality standard.
Please select request type.
Please provide product specifications.
Please enter additional details.
Please select shipping preference.
Notice: By submitting this buying request, the provided product details and requirements may be published publicly on our marketplace.