Hospira, Inc.
FDA Approved Drugs

Hospira, Inc.

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 RX Unclassified
  • Total Records 863
  • Latest Approval Date Sep 11, 2025
  • Data Source FDA
  • First Approval Date Jan 01, 1982
All
863
View
Unclassified
14
View
Discontinued
561
View
RX
288
View
Company Overview

Company

Hospira, Inc.

Country

U.S.A

Website

Visit Website

Email

supportservices@hospira.com

Social Profiles

LinkedIn
Company Snapshot

Hospira, Inc.

275 North Field Drive, Lake Forest, Illinois

U.S.A

www.pfizerhospitalus.com/ supportservices@hospira.com View on Map
FDA Approved Drug Records ( 863 records )
2006
06 Apr
Discontinued Application: 40666

Drug Name

A-HYDROCORT

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE/VIAL

Approval Date

2006-04-06

40666 / 1

Active Ingredient

HYDROCORTISONE SODIUM SUCCINATE

Application Number

40666

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE/VIAL

Approval Date

2006-04-06

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85929

Drug Name

A-HYDROCORT

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE/VIAL

Approval Date

1982-01-01

85929 / 1

Active Ingredient

HYDROCORTISONE SODIUM SUCCINATE

Application Number

85929

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE/VIAL

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85930

Drug Name

A-HYDROCORT

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE/VIAL

Approval Date

1982-01-01

85930 / 1

Active Ingredient

HYDROCORTISONE SODIUM SUCCINATE

Application Number

85930

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE/VIAL

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85931

Drug Name

A-HYDROCORT

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1982-01-01

85931 / 1

Active Ingredient

HYDROCORTISONE SODIUM SUCCINATE

Application Number

85931

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85932

Drug Name

A-HYDROCORT

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1982-01-01

85932 / 1

Active Ingredient

HYDROCORTISONE SODIUM SUCCINATE

Application Number

85932

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1982-01-01

Regulatory Status

Discontinued

2005
20 Dec
Discontinued Application: 40664

Drug Name

A-METHAPRED

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE/VIAL

Approval Date

2005-12-20

40664 / 1

Active Ingredient

METHYLPREDNISOLONE SODIUM SUCCINATE

Application Number

40664

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE/VIAL

Approval Date

2005-12-20

Regulatory Status

Discontinued

2005
20 Dec
Discontinued Application: 40665

Drug Name

A-METHAPRED

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE/VIAL

Approval Date

2005-12-20

40665 / 1

Active Ingredient

METHYLPREDNISOLONE SODIUM SUCCINATE

Application Number

40665

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE/VIAL

Approval Date

2005-12-20

Regulatory Status

Discontinued

2008
25 Nov
Discontinued Application: 40793

Drug Name

A-METHAPRED

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE/VIAL

Approval Date

2008-11-25

40793 / 1

Active Ingredient

METHYLPREDNISOLONE SODIUM SUCCINATE

Application Number

40793

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE/VIAL

Approval Date

2008-11-25

Regulatory Status

Discontinued

2008
25 Nov
Discontinued Application: 40827

Drug Name

A-METHAPRED

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE/VIAL

Approval Date

2008-11-25

40827 / 1

Active Ingredient

METHYLPREDNISOLONE SODIUM SUCCINATE

Application Number

40827

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE/VIAL

Approval Date

2008-11-25

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85852

Drug Name

A-METHAPRED

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1982-01-01

85852 / 1

Active Ingredient

METHYLPREDNISOLONE SODIUM SUCCINATE

Application Number

85852

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85853

Drug Name

A-METHAPRED

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE/VIAL

Approval Date

1982-01-01

85853 / 1

Active Ingredient

METHYLPREDNISOLONE SODIUM SUCCINATE

Application Number

85853

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE/VIAL

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85854

Drug Name

A-METHAPRED

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1982-01-01

85854 / 1

Active Ingredient

METHYLPREDNISOLONE SODIUM SUCCINATE

Application Number

85854

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85855

Drug Name

A-METHAPRED

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE/VIAL

Approval Date

1982-01-01

85855 / 1

Active Ingredient

METHYLPREDNISOLONE SODIUM SUCCINATE

Application Number

85855

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE/VIAL

Approval Date

1982-01-01

Regulatory Status

Discontinued

1987
18 Aug
Discontinued Application: 89173

Drug Name

A-METHAPRED

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1987-08-18

89173 / 1

Active Ingredient

METHYLPREDNISOLONE SODIUM SUCCINATE

Application Number

89173

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1987-08-18

Regulatory Status

Discontinued

1987
18 Aug
Discontinued Application: 89174

Drug Name

A-METHAPRED

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1987-08-18

89174 / 1

Active Ingredient

METHYLPREDNISOLONE SODIUM SUCCINATE

Application Number

89174

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1987-08-18

Regulatory Status

Discontinued

1995
30 Oct
Discontinued Application: 40108

Drug Name

ACETAZOLAMIDE SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1995-10-30

40108 / 1

Active Ingredient

ACETAZOLAMIDE SODIUM

Application Number

40108

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1995-10-30

Regulatory Status

Discontinued

1989
01 May
Discontinued Application: 71364

Drug Name

ACETYLCYSTEINE

Product Number

1

Dosage Form

-

Strength

10%

Approval Date

1989-05-01

71364 / 1

Active Ingredient

ACETYLCYSTEINE

Application Number

71364

Product Number

1

Dosage Form

-

Strength

10%

Approval Date

1989-05-01

Regulatory Status

Discontinued

1989
01 May
Discontinued Application: 71365

Drug Name

ACETYLCYSTEINE

Product Number

1

Dosage Form

-

Strength

20%

Approval Date

1989-05-01

71365 / 1

Active Ingredient

ACETYLCYSTEINE

Application Number

71365

Product Number

1

Dosage Form

-

Strength

20%

Approval Date

1989-05-01

Regulatory Status

Discontinued

1994
30 Aug
RX Application: 73664

Drug Name

ACETYLCYSTEINE

Product Number

1

Dosage Form

-

Strength

10%

Approval Date

1994-08-30

73664 / 1

Active Ingredient

ACETYLCYSTEINE

Application Number

73664

Product Number

1

Dosage Form

-

Strength

10%

Approval Date

1994-08-30

Regulatory Status

RX

1994
30 Aug
RX Application: 74037

Drug Name

ACETYLCYSTEINE

Product Number

1

Dosage Form

-

Strength

20%

Approval Date

1994-08-30

74037 / 1

Active Ingredient

ACETYLCYSTEINE

Application Number

74037

Product Number

1

Dosage Form

-

Strength

20%

Approval Date

1994-08-30

Regulatory Status

RX

1997
22 Apr
Discontinued Application: 74663

Drug Name

ACYCLOVIR SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1997-04-22

74663 / 1

Active Ingredient

ACYCLOVIR SODIUM

Application Number

74663

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1997-04-22

Regulatory Status

Discontinued

1997
22 Apr
Discontinued Application: 74663

Drug Name

ACYCLOVIR SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1997-04-22

74663 / 2

Active Ingredient

ACYCLOVIR SODIUM

Application Number

74663

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1997-04-22

Regulatory Status

Discontinued

1997
22 Apr
Discontinued Application: 74720

Drug Name

ACYCLOVIR SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE/ML

Approval Date

1997-04-22

74720 / 1

Active Ingredient

ACYCLOVIR SODIUM

Application Number

74720

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE/ML

Approval Date

1997-04-22

Regulatory Status

Discontinued

1997
22 Apr
Discontinued Application: 74758

Drug Name

ACYCLOVIR SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1997-04-22

74758 / 1

Active Ingredient

ACYCLOVIR SODIUM

Application Number

74758

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1997-04-22

Regulatory Status

Discontinued

1997
22 Apr
Discontinued Application: 74758

Drug Name

ACYCLOVIR SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1997-04-22

74758 / 2

Active Ingredient

ACYCLOVIR SODIUM

Application Number

74758

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1997-04-22

Regulatory Status

Discontinued

1999
25 Feb
Discontinued Application: 75065

Drug Name

ACYCLOVIR SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/ML

Approval Date

1999-02-25

75065 / 1

Active Ingredient

ACYCLOVIR SODIUM

Application Number

75065

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/ML

Approval Date

1999-02-25

Regulatory Status

Discontinued

2014
24 Mar
Discontinued Application: 203883

Drug Name

ADENOSINE

Product Number

1

Dosage Form

-

Strength

60MG/20ML (3MG/ML)

Approval Date

2014-03-24

203883 / 1

Active Ingredient

ADENOSINE

Application Number

203883

Product Number

1

Dosage Form

-

Strength

60MG/20ML (3MG/ML)

Approval Date

2014-03-24

Regulatory Status

Discontinued

2014
24 Mar
Discontinued Application: 203883

Drug Name

ADENOSINE

Product Number

2

Dosage Form

-

Strength

90MG/30ML (3MG/ML)

Approval Date

2014-03-24

203883 / 2

Active Ingredient

ADENOSINE

Application Number

203883

Product Number

2

Dosage Form

-

Strength

90MG/30ML (3MG/ML)

Approval Date

2014-03-24

Regulatory Status

Discontinued

1999
28 Oct
Discontinued Application: 75221

Drug Name

ALFENTANIL

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE/ML

Approval Date

1999-10-28

75221 / 1

Active Ingredient

ALFENTANIL HYDROCHLORIDE

Application Number

75221

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE/ML

Approval Date

1999-10-28

Regulatory Status

Discontinued

1982
07 Sep
RX Application: 18227

Drug Name

AMIDATE

Product Number

1

Dosage Form

-

Strength

2MG/ML

Approval Date

1982-09-07

18227 / 1

Active Ingredient

ETOMIDATE

Application Number

18227

Product Number

1

Dosage Form

-

Strength

2MG/ML

Approval Date

1982-09-07

Regulatory Status

RX

1994
30 Nov
Discontinued Application: 63263

Drug Name

AMIKACIN SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/ML

Approval Date

1994-11-30

63263 / 1

Active Ingredient

AMIKACIN SULFATE

Application Number

63263

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/ML

Approval Date

1994-11-30

Regulatory Status

Discontinued

1994
30 Nov
Discontinued Application: 63264

Drug Name

AMIKACIN SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE/ML

Approval Date

1994-11-30

63264 / 1

Active Ingredient

AMIKACIN SULFATE

Application Number

63264

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE/ML

Approval Date

1994-11-30

Regulatory Status

Discontinued

1994
31 Oct
Discontinued Application: 63283

Drug Name

AMIKACIN SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 62.5MG BASE/ML

Approval Date

1994-10-31

63283 / 1

Active Ingredient

AMIKACIN SULFATE

Application Number

63283

Product Number

1

Dosage Form

-

Strength

EQ 62.5MG BASE/ML

Approval Date

1994-10-31

Regulatory Status

Discontinued

1993
30 Jul
Discontinued Application: 63350

Drug Name

AMIKACIN SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/ML

Approval Date

1993-07-30

63350 / 1

Active Ingredient

AMIKACIN SULFATE

Application Number

63350

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/ML

Approval Date

1993-07-30

Regulatory Status

Discontinued

1993
30 Jul
Discontinued Application: 63350

Drug Name

AMIKACIN SULFATE

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE/ML

Approval Date

1993-07-30

63350 / 2

Active Ingredient

AMIKACIN SULFATE

Application Number

63350

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE/ML

Approval Date

1993-07-30

Regulatory Status

Discontinued

1995
26 Jun
Discontinued Application: 64098

Drug Name

AMIKACIN SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE/ML

Approval Date

1995-06-26

64098 / 1

Active Ingredient

AMIKACIN SULFATE

Application Number

64098

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE/ML

Approval Date

1995-06-26

Regulatory Status

Discontinued

1995
20 Jun
Discontinued Application: 64099

Drug Name

AMIKACIN SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE/ML

Approval Date

1995-06-20

64099 / 1

Active Ingredient

AMIKACIN SULFATE

Application Number

64099

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE/ML

Approval Date

1995-06-20

Regulatory Status

Discontinued

1997
02 Apr
Discontinued Application: 64146

Drug Name

AMIKACIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/100ML

Approval Date

1997-04-02

64146 / 1

Active Ingredient

AMIKACIN SULFATE

Application Number

64146

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/100ML

Approval Date

1997-04-02

Regulatory Status

Discontinued

1984
06 Apr
Discontinued Application: 18901

Drug Name

AMINESS 5.2% ESSENTIAL AMINO ACIDS W/ HISTADINE

Product Number

1

Dosage Form

-

Strength

5.2% (5.2GM/100ML)

Approval Date

1984-04-06

18901 / 1

Active Ingredient

AMINO ACIDS

Application Number

18901

Product Number

1

Dosage Form

-

Strength

5.2% (5.2GM/100ML)

Approval Date

1984-04-06

Regulatory Status

Discontinued

1988
16 Jun
Discontinued Application: 70888

Drug Name

AMINOCAPROIC ACID

Product Number

1

Dosage Form

-

Strength

250MG/ML

Approval Date

1988-06-16

70888 / 1

Active Ingredient

AMINOCAPROIC ACID

Application Number

70888

Product Number

1

Dosage Form

-

Strength

250MG/ML

Approval Date

1988-06-16

Regulatory Status

Discontinued

1987
09 Mar
RX Application: 70010

Drug Name

AMINOCAPROIC ACID IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

250MG/ML

Approval Date

1987-03-09

70010 / 1

Active Ingredient

AMINOCAPROIC ACID

Application Number

70010

Product Number

1

Dosage Form

-

Strength

250MG/ML

Approval Date

1987-03-09

Regulatory Status

RX

1983
26 Oct
RX Application: 87242

Drug Name

AMINOPHYLLINE

Product Number

1

Dosage Form

-

Strength

25MG/ML

Approval Date

1983-10-26

87242 / 1

Active Ingredient

AMINOPHYLLINE

Application Number

87242

Product Number

1

Dosage Form

-

Strength

25MG/ML

Approval Date

1983-10-26

Regulatory Status

RX

1982
23 Jul
Discontinued Application: 87601

Drug Name

AMINOPHYLLINE

Product Number

1

Dosage Form

-

Strength

25MG/ML

Approval Date

1982-07-23

87601 / 1

Active Ingredient

AMINOPHYLLINE

Application Number

87601

Product Number

1

Dosage Form

-

Strength

25MG/ML

Approval Date

1982-07-23

Regulatory Status

Discontinued

1983
03 May
Discontinued Application: 88147

Drug Name

AMINOPHYLLINE IN SODIUM CHLORIDE 0.45%

Product Number

2

Dosage Form

-

Strength

100MG/100ML

Approval Date

1983-05-03

88147 / 2

Active Ingredient

AMINOPHYLLINE

Application Number

88147

Product Number

2

Dosage Form

-

Strength

100MG/100ML

Approval Date

1983-05-03

Regulatory Status

Discontinued

1983
03 May
Discontinued Application: 88147

Drug Name

AMINOPHYLLINE IN SODIUM CHLORIDE 0.45%

Product Number

3

Dosage Form

-

Strength

200MG/100ML

Approval Date

1983-05-03

88147 / 3

Active Ingredient

AMINOPHYLLINE

Application Number

88147

Product Number

3

Dosage Form

-

Strength

200MG/100ML

Approval Date

1983-05-03

Regulatory Status

Discontinued

1984
12 Dec
Discontinued Application: 18924

Drug Name

AMINOPHYLLINE IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

100MG/100ML

Approval Date

1984-12-12

18924 / 1

Active Ingredient

AMINOPHYLLINE

Application Number

18924

Product Number

1

Dosage Form

-

Strength

100MG/100ML

Approval Date

1984-12-12

Regulatory Status

Discontinued

1984
12 Dec
Discontinued Application: 18924

Drug Name

AMINOPHYLLINE IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

200MG/100ML

Approval Date

1984-12-12

18924 / 2

Active Ingredient

AMINOPHYLLINE

Application Number

18924

Product Number

2

Dosage Form

-

Strength

200MG/100ML

Approval Date

1984-12-12

Regulatory Status

Discontinued

1984
12 Dec
Discontinued Application: 18924

Drug Name

AMINOPHYLLINE IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

Product Number

3

Dosage Form

-

Strength

400MG/100ML

Approval Date

1984-12-12

18924 / 3

Active Ingredient

AMINOPHYLLINE

Application Number

18924

Product Number

3

Dosage Form

-

Strength

400MG/100ML

Approval Date

1984-12-12

Regulatory Status

Discontinued

1984
12 Dec
Discontinued Application: 18924

Drug Name

AMINOPHYLLINE IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

Product Number

4

Dosage Form

-

Strength

500MG/100ML

Approval Date

1984-12-12

18924 / 4

Active Ingredient

AMINOPHYLLINE

Application Number

18924

Product Number

4

Dosage Form

-

Strength

500MG/100ML

Approval Date

1984-12-12

Regulatory Status

Discontinued

1988
01 Nov
Discontinued Application: 19681

Drug Name

AMINOSYN II 3.5% IN DEXTROSE 25% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

3.5%;25GM/100ML

Approval Date

1988-11-01

19681 / 1

Active Ingredient

AMINO ACIDS; DEXTROSE

Application Number

19681

Product Number

1

Dosage Form

-

Strength

3.5%;25GM/100ML

Approval Date

1988-11-01

Regulatory Status

Discontinued

1988
01 Nov
Discontinued Application: 19681

Drug Name

AMINOSYN II 3.5% IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

3.5%;5GM/100ML

Approval Date

1988-11-01

19681 / 2

Active Ingredient

AMINO ACIDS; DEXTROSE

Application Number

19681

Product Number

2

Dosage Form

-

Strength

3.5%;5GM/100ML

Approval Date

1988-11-01

Regulatory Status

Discontinued

1988
01 Nov
Discontinued Application: 19682

Drug Name

AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

3.5%;5GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100ML

Approval Date

1988-11-01

19682 / 1

Active Ingredient

AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE

Application Number

19682

Product Number

1

Dosage Form

-

Strength

3.5%;5GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100ML

Approval Date

1988-11-01

Regulatory Status

Discontinued

1988
07 Nov
Discontinued Application: 19683

Drug Name

AMINOSYN II 3.5% W/ ELECTROLYTES IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

3.5%;36.8MG/100ML;25GM/100ML;51MG/100ML;22.4MG/100ML;261MG/100ML;205MG/100ML

Approval Date

1988-11-07

19683 / 1

Active Ingredient

AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE

Application Number

19683

Product Number

1

Dosage Form

-

Strength

3.5%;36.8MG/100ML;25GM/100ML;51MG/100ML;22.4MG/100ML;261MG/100ML;205MG/100ML

Approval Date

1988-11-07

Regulatory Status

Discontinued

1988
01 Nov
Discontinued Application: 19681

Drug Name

AMINOSYN II 4.25% IN DEXTROSE 10% IN PLASTIC CONTAINER

Product Number

4

Dosage Form

-

Strength

4.25%;10GM/100ML

Approval Date

1988-11-01

19681 / 4

Active Ingredient

AMINO ACIDS; DEXTROSE

Application Number

19681

Product Number

4

Dosage Form

-

Strength

4.25%;10GM/100ML

Approval Date

1988-11-01

Regulatory Status

Discontinued

1988
01 Nov
Discontinued Application: 19681

Drug Name

AMINOSYN II 4.25% IN DEXTROSE 20% IN PLASTIC CONTAINER

Product Number

5

Dosage Form

-

Strength

4.25%;20GM/100ML

Approval Date

1988-11-01

19681 / 5

Active Ingredient

AMINO ACIDS; DEXTROSE

Application Number

19681

Product Number

5

Dosage Form

-

Strength

4.25%;20GM/100ML

Approval Date

1988-11-01

Regulatory Status

Discontinued

1988
01 Nov
Discontinued Application: 19681

Drug Name

AMINOSYN II 4.25% IN DEXTROSE 25% IN PLASTIC CONTAINER

Product Number

3

Dosage Form

-

Strength

4.25%;25GM/100ML

Approval Date

1988-11-01

19681 / 3

Active Ingredient

AMINO ACIDS; DEXTROSE

Application Number

19681

Product Number

3

Dosage Form

-

Strength

4.25%;25GM/100ML

Approval Date

1988-11-01

Regulatory Status

Discontinued

1988
01 Nov
Discontinued Application: 19682

Drug Name

AMINOSYN II 4.25% M IN DEXTROSE 10% IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

4.25%;5GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100ML

Approval Date

1988-11-01

19682 / 2

Active Ingredient

AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE

Application Number

19682

Product Number

2

Dosage Form

-

Strength

4.25%;5GM/100ML;30MG/100ML;97MG/100ML;120MG/100ML;49.3MG/100ML

Approval Date

1988-11-01

Regulatory Status

Discontinued

1988
01 Nov
Discontinued Application: 19682

Drug Name

AMINOSYN II 4.25% W/ ELECT AND ADJUSTED PHOSPHATE IN DEXTROSE 10% IN PLASTIC CONTAINER

Product Number

3

Dosage Form

-

Strength

4.25%;10GM/100ML;51MG/100ML;176.5MG/100ML;22.4MG/100ML;104.5MG/100ML;205MG/100ML

Approval Date

1988-11-01

19682 / 3

Active Ingredient

AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM ACETATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE

Application Number

19682

Product Number

3

Dosage Form

-

Strength

4.25%;10GM/100ML;51MG/100ML;176.5MG/100ML;22.4MG/100ML;104.5MG/100ML;205MG/100ML

Approval Date

1988-11-01

Regulatory Status

Discontinued

1988
07 Nov
Discontinued Application: 19683

Drug Name

AMINOSYN II 4.25% W/ ELECTROLYTES IN DEXTROSE 20% W/ CALCIUM IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

4.25%;36.8MG/100ML;20GM/100ML;51MG/100ML;22.4MG/100ML;261MG/100ML;205MG/100ML

Approval Date

1988-11-07

19683 / 2

Active Ingredient

AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE

Application Number

19683

Product Number

2

Dosage Form

-

Strength

4.25%;36.8MG/100ML;20GM/100ML;51MG/100ML;22.4MG/100ML;261MG/100ML;205MG/100ML

Approval Date

1988-11-07

Regulatory Status

Discontinued

1988
07 Nov
Discontinued Application: 19683

Drug Name

AMINOSYN II 4.25% W/ ELECTROLYTES IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER

Product Number

3

Dosage Form

-

Strength

4.25%;36.8MG/100ML;25GM/100ML;51MG/100ML;22.4MG/100ML;261MG/100ML;205MG/100ML

Approval Date

1988-11-07

19683 / 3

Active Ingredient

AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE

Application Number

19683

Product Number

3

Dosage Form

-

Strength

4.25%;36.8MG/100ML;25GM/100ML;51MG/100ML;22.4MG/100ML;261MG/100ML;205MG/100ML

Approval Date

1988-11-07

Regulatory Status

Discontinued

1988
01 Nov
Discontinued Application: 19681

Drug Name

AMINOSYN II 5% IN DEXTROSE 25% IN PLASTIC CONTAINER

Product Number

6

Dosage Form

-

Strength

5%;25GM/100ML

Approval Date

1988-11-01

19681 / 6

Active Ingredient

AMINO ACIDS; DEXTROSE

Application Number

19681

Product Number

6

Dosage Form

-

Strength

5%;25GM/100ML

Approval Date

1988-11-01

Regulatory Status

Discontinued

1988
07 Nov
Discontinued Application: 19683

Drug Name

AMINOSYN II 5% W/ ELECTROLYTES IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER

Product Number

4

Dosage Form

-

Strength

5%;36.8MG/100ML;25GM/100ML;51MG/100ML;22.4MG/100ML;261MG/100ML;205MG/100ML

Approval Date

1988-11-07

19683 / 4

Active Ingredient

AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE

Application Number

19683

Product Number

4

Dosage Form

-

Strength

5%;36.8MG/100ML;25GM/100ML;51MG/100ML;22.4MG/100ML;261MG/100ML;205MG/100ML

Approval Date

1988-11-07

Regulatory Status

Discontinued

2002
18 Oct
Discontinued Application: 75955

Drug Name

AMIODARONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

2002-10-18

75955 / 1

Active Ingredient

AMIODARONE HYDROCHLORIDE

Application Number

75955

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

2002-10-18

Regulatory Status

Discontinued

2002
15 Oct
Discontinued Application: 76108

Drug Name

AMIODARONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

2002-10-15

76108 / 1

Active Ingredient

AMIODARONE HYDROCHLORIDE

Application Number

76108

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

2002-10-15

Regulatory Status

Discontinued

2013
25 Nov
Discontinued Application: 203884

Drug Name

AMIODARONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

2013-11-25

203884 / 1

Active Ingredient

AMIODARONE HYDROCHLORIDE

Application Number

203884

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

2013-11-25

Regulatory Status

Discontinued

2013
25 Nov
Discontinued Application: 203885

Drug Name

AMIODARONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

2013-11-25

203885 / 1

Active Ingredient

AMIODARONE HYDROCHLORIDE

Application Number

203885

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

2013-11-25

Regulatory Status

Discontinued

1984
13 Jun
RX Application: 88366

Drug Name

AMMONIUM CHLORIDE IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

5MEQ/ML

Approval Date

1984-06-13

88366 / 1

Active Ingredient

AMMONIUM CHLORIDE

Application Number

88366

Product Number

1

Dosage Form

-

Strength

5MEQ/ML

Approval Date

1984-06-13

Regulatory Status

RX

2011
21 Dec
Discontinued Application: 90375

Drug Name

AMPICILLIN AND SULBACTAM

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2011-12-21

90375 / 1

Active Ingredient

AMPICILLIN SODIUM; SULBACTAM SODIUM

Application Number

90375

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2011-12-21

Regulatory Status

Discontinued

2011
21 Dec
Discontinued Application: 90375

Drug Name

AMPICILLIN AND SULBACTAM

Product Number

2

Dosage Form

-

Strength

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

Approval Date

2011-12-21

90375 / 2

Active Ingredient

AMPICILLIN SODIUM; SULBACTAM SODIUM

Application Number

90375

Product Number

2

Dosage Form

-

Strength

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

Approval Date

2011-12-21

Regulatory Status

Discontinued

2011
21 Dec
Discontinued Application: 90646

Drug Name

AMPICILLIN AND SULBACTAM

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2011-12-21

90646 / 1

Active Ingredient

AMPICILLIN SODIUM; SULBACTAM SODIUM

Application Number

90646

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2011-12-21

Regulatory Status

Discontinued

2011
21 Dec
Discontinued Application: 90653

Drug Name

AMPICILLIN AND SULBACTAM

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2011-12-21

90653 / 1

Active Ingredient

AMPICILLIN SODIUM; SULBACTAM SODIUM

Application Number

90653

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2011-12-21

Regulatory Status

Discontinued

2011
21 Dec
Discontinued Application: 90653

Drug Name

AMPICILLIN AND SULBACTAM

Product Number

2

Dosage Form

-

Strength

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

Approval Date

2011-12-21

90653 / 2

Active Ingredient

AMPICILLIN SODIUM; SULBACTAM SODIUM

Application Number

90653

Product Number

2

Dosage Form

-

Strength

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

Approval Date

2011-12-21

Regulatory Status

Discontinued

2015
04 Sep
Discontinued Application: 202864

Drug Name

AMPICILLIN SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE/VIAL

Approval Date

2015-09-04

202864 / 1

Active Ingredient

AMPICILLIN SODIUM

Application Number

202864

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE/VIAL

Approval Date

2015-09-04

Regulatory Status

Discontinued

2015
04 Sep
Discontinued Application: 202864

Drug Name

AMPICILLIN SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2015-09-04

202864 / 2

Active Ingredient

AMPICILLIN SODIUM

Application Number

202864

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2015-09-04

Regulatory Status

Discontinued

2015
04 Sep
Discontinued Application: 202864

Drug Name

AMPICILLIN SODIUM

Product Number

3

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2015-09-04

202864 / 3

Active Ingredient

AMPICILLIN SODIUM

Application Number

202864

Product Number

3

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2015-09-04

Regulatory Status

Discontinued

2015
04 Sep
Discontinued Application: 202864

Drug Name

AMPICILLIN SODIUM

Product Number

4

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

2015-09-04

202864 / 4

Active Ingredient

AMPICILLIN SODIUM

Application Number

202864

Product Number

4

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

2015-09-04

Regulatory Status

Discontinued

2015
04 Sep
Discontinued Application: 202865

Drug Name

AMPICILLIN SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 10GM BASE/VIAL

Approval Date

2015-09-04

202865 / 1

Active Ingredient

AMPICILLIN SODIUM

Application Number

202865

Product Number

1

Dosage Form

-

Strength

EQ 10GM BASE/VIAL

Approval Date

2015-09-04

Regulatory Status

Discontinued

1998
03 Aug
Discontinued Application: 74616

Drug Name

AMRINONE LACTATE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

1998-08-03

74616 / 1

Active Ingredient

INAMRINONE LACTATE

Application Number

74616

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

1998-08-03

Regulatory Status

Discontinued

2016
21 Sep
RX Application: 204120

Drug Name

ARGATROBAN

Product Number

1

Dosage Form

-

Strength

250MG/2.5ML (100MG/ML)

Approval Date

2016-09-21

204120 / 1

Active Ingredient

ARGATROBAN

Application Number

204120

Product Number

1

Dosage Form

-

Strength

250MG/2.5ML (100MG/ML)

Approval Date

2016-09-21

Regulatory Status

RX

2010
18 Jun
Discontinued Application: 79138

Drug Name

ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE

Product Number

1

Dosage Form

-

Strength

4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)

Approval Date

2010-06-18

79138 / 1

Active Ingredient

ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE

Application Number

79138

Product Number

1

Dosage Form

-

Strength

4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG BASE/ML)

Approval Date

2010-06-18

Regulatory Status

Discontinued

1996
23 Dec
Discontinued Application: 74632

Drug Name

ATRACURIUM BESYLATE

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1996-12-23

74632 / 1

Active Ingredient

ATRACURIUM BESYLATE

Application Number

74632

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1996-12-23

Regulatory Status

Discontinued

1997
28 Mar
Discontinued Application: 74740

Drug Name

ATRACURIUM BESYLATE

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1997-03-28

74740 / 1

Active Ingredient

ATRACURIUM BESYLATE

Application Number

74740

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1997-03-28

Regulatory Status

Discontinued

2012
18 Oct
RX Application: 90761

Drug Name

ATRACURIUM BESYLATE

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2012-10-18

90761 / 1

Active Ingredient

ATRACURIUM BESYLATE

Application Number

90761

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2012-10-18

Regulatory Status

RX

1996
23 Dec
Discontinued Application: 74633

Drug Name

ATRACURIUM BESYLATE PRESERVATIVE FREE

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1996-12-23

74633 / 1

Active Ingredient

ATRACURIUM BESYLATE

Application Number

74633

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1996-12-23

Regulatory Status

Discontinued

1997
25 Mar
Discontinued Application: 74639

Drug Name

ATRACURIUM BESYLATE PRESERVATIVE FREE

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1997-03-25

74639 / 1

Active Ingredient

ATRACURIUM BESYLATE

Application Number

74639

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1997-03-25

Regulatory Status

Discontinued

1997
28 Mar
Discontinued Application: 74741

Drug Name

ATRACURIUM BESYLATE PRESERVATIVE FREE

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1997-03-28

74741 / 1

Active Ingredient

ATRACURIUM BESYLATE

Application Number

74741

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1997-03-28

Regulatory Status

Discontinued

2012
18 Oct
RX Application: 90782

Drug Name

ATRACURIUM BESYLATE PRESERVATIVE FREE

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2012-10-18

90782 / 1

Active Ingredient

ATRACURIUM BESYLATE

Application Number

90782

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2012-10-18

Regulatory Status

RX

2001
09 Jul
RX Application: 21146

Drug Name

ATROPINE SULFATE

Product Number

1

Dosage Form

-

Strength

0.5MG/5ML (0.1MG/ML)

Approval Date

2001-07-09

21146 / 1

Active Ingredient

ATROPINE SULFATE

Application Number

21146

Product Number

1

Dosage Form

-

Strength

0.5MG/5ML (0.1MG/ML)

Approval Date

2001-07-09

Regulatory Status

RX

2001
09 Jul
RX Application: 21146

Drug Name

ATROPINE SULFATE

Product Number

2

Dosage Form

-

Strength

0.25MG/5ML (0.05MG/ML)

Approval Date

2001-07-09

21146 / 2

Active Ingredient

ATROPINE SULFATE

Application Number

21146

Product Number

2

Dosage Form

-

Strength

0.25MG/5ML (0.05MG/ML)

Approval Date

2001-07-09

Regulatory Status

RX

2001
09 Jul
RX Application: 21146

Drug Name

ATROPINE SULFATE

Product Number

3

Dosage Form

-

Strength

1MG/10ML (0.1MG/ML)

Approval Date

2001-07-09

21146 / 3

Active Ingredient

ATROPINE SULFATE

Application Number

21146

Product Number

3

Dosage Form

-

Strength

1MG/10ML (0.1MG/ML)

Approval Date

2001-07-09

Regulatory Status

RX

2009
26 Jun
RX Application: 65500

Drug Name

AZITHROMYCIN

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2009-06-26

65500 / 1

Active Ingredient

AZITHROMYCIN

Application Number

65500

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2009-06-26

Regulatory Status

RX

2009
26 Jun
Discontinued Application: 65511

Drug Name

AZITHROMYCIN

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2009-06-26

65511 / 1

Active Ingredient

AZITHROMYCIN

Application Number

65511

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2009-06-26

Regulatory Status

Discontinued

2021
08 Nov
RX Application: 206517

Drug Name

AZTREONAM

Product Number

1

Dosage Form

-

Strength

1GM/VIAL

Approval Date

2021-11-08

206517 / 1

Active Ingredient

AZTREONAM

Application Number

206517

Product Number

1

Dosage Form

-

Strength

1GM/VIAL

Approval Date

2021-11-08

Regulatory Status

RX

2021
08 Nov
RX Application: 206517

Drug Name

AZTREONAM

Product Number

2

Dosage Form

-

Strength

2GM/VIAL

Approval Date

2021-11-08

206517 / 2

Active Ingredient

AZTREONAM

Application Number

206517

Product Number

2

Dosage Form

-

Strength

2GM/VIAL

Approval Date

2021-11-08

Regulatory Status

RX

1982
29 Oct
RX Application: 18800

Drug Name

BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

90MG/10ML (9MG/ML)

Approval Date

1982-10-29

18800 / 1

Active Ingredient

SODIUM CHLORIDE

Application Number

18800

Product Number

1

Dosage Form

-

Strength

90MG/10ML (9MG/ML)

Approval Date

1982-10-29

Regulatory Status

RX

1982
29 Oct
RX Application: 18800

Drug Name

BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

180MG/20ML (9MG/ML)

Approval Date

1982-10-29

18800 / 2

Active Ingredient

SODIUM CHLORIDE

Application Number

18800

Product Number

2

Dosage Form

-

Strength

180MG/20ML (9MG/ML)

Approval Date

1982-10-29

Regulatory Status

RX

1982
29 Oct
RX Application: 18800

Drug Name

BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

3

Dosage Form

-

Strength

270MG/30ML (9MG/ML)

Approval Date

1982-10-29

18800 / 3

Active Ingredient

SODIUM CHLORIDE

Application Number

18800

Product Number

3

Dosage Form

-

Strength

270MG/30ML (9MG/ML)

Approval Date

1982-10-29

Regulatory Status

RX

1982
27 Oct
RX Application: 18802

Drug Name

BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

100%

Approval Date

1982-10-27

18802 / 1

Active Ingredient

STERILE WATER FOR INJECTION

Application Number

18802

Product Number

1

Dosage Form

-

Strength

100%

Approval Date

1982-10-27

Regulatory Status

RX

2022
15 Dec
Discontinued Application: 211530

Drug Name

BENDAMUSTINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG/ML (25MG/ML)

Approval Date

2022-12-15

211530 / 1

Active Ingredient

BENDAMUSTINE HYDROCHLORIDE

Application Number

211530

Product Number

1

Dosage Form

-

Strength

25MG/ML (25MG/ML)

Approval Date

2022-12-15

Regulatory Status

Discontinued

2022
15 Dec
Discontinued Application: 211530

Drug Name

BENDAMUSTINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

100MG/4ML (25MG/ML)

Approval Date

2022-12-15

211530 / 2

Active Ingredient

BENDAMUSTINE HYDROCHLORIDE

Application Number

211530

Product Number

2

Dosage Form

-

Strength

100MG/4ML (25MG/ML)

Approval Date

2022-12-15

Regulatory Status

Discontinued

2022
15 Dec
Discontinued Application: 211530

Drug Name

BENDAMUSTINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

200MG/8ML (25MG/ML)

Approval Date

2022-12-15

211530 / 3

Active Ingredient

BENDAMUSTINE HYDROCHLORIDE

Application Number

211530

Product Number

3

Dosage Form

-

Strength

200MG/8ML (25MG/ML)

Approval Date

2022-12-15

Regulatory Status

Discontinued

2015
14 Jul
Discontinued Application: 90811

Drug Name

BIVALIRUDIN

Product Number

1

Dosage Form

-

Strength

250MG/VIAL

Approval Date

2015-07-14

90811 / 1

Active Ingredient

BIVALIRUDIN

Application Number

90811

Product Number

1

Dosage Form

-

Strength

250MG/VIAL

Approval Date

2015-07-14

Regulatory Status

Discontinued

2015
14 Jul
Discontinued Application: 90816

Drug Name

BIVALIRUDIN

Product Number

1

Dosage Form

-

Strength

250MG/VIAL

Approval Date

2015-07-14

90816 / 1

Active Ingredient

BIVALIRUDIN

Application Number

90816

Product Number

1

Dosage Form

-

Strength

250MG/VIAL

Approval Date

2015-07-14

Regulatory Status

Discontinued

2000
10 Mar
RX Application: 65031

Drug Name

BLEOMYCIN SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 15 UNITS BASE/VIAL

Approval Date

2000-03-10

65031 / 1

Active Ingredient

BLEOMYCIN SULFATE

Application Number

65031

Product Number

1

Dosage Form

-

Strength

EQ 15 UNITS BASE/VIAL

Approval Date

2000-03-10

Regulatory Status

RX

2000
10 Mar
RX Application: 65031

Drug Name

BLEOMYCIN SULFATE

Product Number

2

Dosage Form

-

Strength

EQ 30 UNITS BASE/VIAL

Approval Date

2000-03-10

65031 / 2

Active Ingredient

BLEOMYCIN SULFATE

Application Number

65031

Product Number

2

Dosage Form

-

Strength

EQ 30 UNITS BASE/VIAL

Approval Date

2000-03-10

Regulatory Status

RX

2022
26 Jul
RX Application: 208460

Drug Name

BORTEZOMIB

Product Number

1

Dosage Form

-

Strength

3.5MG/VIAL

Approval Date

2022-07-26

208460 / 1

Active Ingredient

BORTEZOMIB

Application Number

208460

Product Number

1

Dosage Form

-

Strength

3.5MG/VIAL

Approval Date

2022-07-26

Regulatory Status

RX

2022
02 May
RX Application: 209191

Drug Name

BORTEZOMIB

Product Number

1

Dosage Form

-

Strength

1MG/VIAL

Approval Date

2022-05-02

209191 / 1

Active Ingredient

BORTEZOMIB

Application Number

209191

Product Number

1

Dosage Form

-

Strength

1MG/VIAL

Approval Date

2022-05-02

Regulatory Status

RX

2022
02 May
RX Application: 209191

Drug Name

BORTEZOMIB

Product Number

2

Dosage Form

-

Strength

2.5MG/VIAL

Approval Date

2022-05-02

209191 / 2

Active Ingredient

BORTEZOMIB

Application Number

209191

Product Number

2

Dosage Form

-

Strength

2.5MG/VIAL

Approval Date

2022-05-02

Regulatory Status

RX

1986
29 Apr
Discontinued Application: 19030

Drug Name

BRETYLIUM TOSYLATE

Product Number

1

Dosage Form

-

Strength

50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1986-04-29

19030 / 1

Active Ingredient

BRETYLIUM TOSYLATE

Application Number

19030

Product Number

1

Dosage Form

-

Strength

50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1986-04-29

Regulatory Status

Discontinued

1986
29 Apr
Discontinued Application: 19033

Drug Name

BRETYLIUM TOSYLATE

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

1986-04-29

19033 / 1

Active Ingredient

BRETYLIUM TOSYLATE

Application Number

19033

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

1986-04-29

Regulatory Status

Discontinued

1986
29 Apr
Discontinued Application: 19008

Drug Name

BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

800MG/100ML

Approval Date

1986-04-29

19008 / 1

Active Ingredient

BRETYLIUM TOSYLATE

Application Number

19008

Product Number

1

Dosage Form

-

Strength

800MG/100ML

Approval Date

1986-04-29

Regulatory Status

Discontinued

1986
29 Apr
Discontinued Application: 19008

Drug Name

BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

200MG/100ML

Approval Date

1986-04-29

19008 / 2

Active Ingredient

BRETYLIUM TOSYLATE

Application Number

19008

Product Number

2

Dosage Form

-

Strength

200MG/100ML

Approval Date

1986-04-29

Regulatory Status

Discontinued

1986
29 Apr
Discontinued Application: 19008

Drug Name

BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

3

Dosage Form

-

Strength

400MG/100ML

Approval Date

1986-04-29

19008 / 3

Active Ingredient

BRETYLIUM TOSYLATE

Application Number

19008

Product Number

3

Dosage Form

-

Strength

400MG/100ML

Approval Date

1986-04-29

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17954

Drug Name

BRETYLOL

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

1982-01-01

17954 / 1

Active Ingredient

BRETYLIUM TOSYLATE

Application Number

17954

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1997
30 Oct
Discontinued Application: 74160

Drug Name

BUMETANIDE

Product Number

1

Dosage Form

-

Strength

0.25MG/ML

Approval Date

1997-10-30

74160 / 1

Active Ingredient

BUMETANIDE

Application Number

74160

Product Number

1

Dosage Form

-

Strength

0.25MG/ML

Approval Date

1997-10-30

Regulatory Status

Discontinued

1994
31 Oct
Discontinued Application: 74332

Drug Name

BUMETANIDE

Product Number

1

Dosage Form

-

Strength

0.25MG/ML

Approval Date

1994-10-31

74332 / 1

Active Ingredient

BUMETANIDE

Application Number

74332

Product Number

1

Dosage Form

-

Strength

0.25MG/ML

Approval Date

1994-10-31

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 18053

Drug Name

BUPIVACAINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

1982-01-01

18053 / 1

Active Ingredient

BUPIVACAINE HYDROCHLORIDE

Application Number

18053

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 18053

Drug Name

BUPIVACAINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

0.25%

Approval Date

1982-01-01

18053 / 2

Active Ingredient

BUPIVACAINE HYDROCHLORIDE

Application Number

18053

Product Number

2

Dosage Form

-

Strength

0.25%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 18053

Drug Name

BUPIVACAINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

0.75%

Approval Date

1982-01-01

18053 / 3

Active Ingredient

BUPIVACAINE HYDROCHLORIDE

Application Number

18053

Product Number

3

Dosage Form

-

Strength

0.75%

Approval Date

1982-01-01

Regulatory Status

Discontinued

-
Unclassified Application: 22046

Drug Name

BUPIVACAINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

0.5%

Approval Date

-

22046 / 2

Active Ingredient

BUPIVACAINE HYDROCHLORIDE

Application Number

22046

Product Number

2

Dosage Form

-

Strength

0.5%

Approval Date

-

Regulatory Status

Unclassified

1987
17 Feb
RX Application: 70583

Drug Name

BUPIVACAINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.25%

Approval Date

1987-02-17

70583 / 1

Active Ingredient

BUPIVACAINE HYDROCHLORIDE

Application Number

70583

Product Number

1

Dosage Form

-

Strength

0.25%

Approval Date

1987-02-17

Regulatory Status

RX

1986
17 Feb
RX Application: 70584

Drug Name

BUPIVACAINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

1986-02-17

70584 / 1

Active Ingredient

BUPIVACAINE HYDROCHLORIDE

Application Number

70584

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

1986-02-17

Regulatory Status

RX

1987
03 Mar
RX Application: 70585

Drug Name

BUPIVACAINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.75%

Approval Date

1987-03-03

70585 / 1

Active Ingredient

BUPIVACAINE HYDROCHLORIDE

Application Number

70585

Product Number

1

Dosage Form

-

Strength

0.75%

Approval Date

1987-03-03

Regulatory Status

RX

1987
03 Mar
Discontinued Application: 70586

Drug Name

BUPIVACAINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.25%

Approval Date

1987-03-03

70586 / 1

Active Ingredient

BUPIVACAINE HYDROCHLORIDE

Application Number

70586

Product Number

1

Dosage Form

-

Strength

0.25%

Approval Date

1987-03-03

Regulatory Status

Discontinued

1987
03 Mar
Discontinued Application: 70587

Drug Name

BUPIVACAINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.75%

Approval Date

1987-03-03

70587 / 1

Active Ingredient

BUPIVACAINE HYDROCHLORIDE

Application Number

70587

Product Number

1

Dosage Form

-

Strength

0.75%

Approval Date

1987-03-03

Regulatory Status

Discontinued

1987
17 Feb
RX Application: 70590

Drug Name

BUPIVACAINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.25%

Approval Date

1987-02-17

70590 / 1

Active Ingredient

BUPIVACAINE HYDROCHLORIDE

Application Number

70590

Product Number

1

Dosage Form

-

Strength

0.25%

Approval Date

1987-02-17

Regulatory Status

RX

1987
03 Mar
RX Application: 70597

Drug Name

BUPIVACAINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

1987-03-03

70597 / 1

Active Ingredient

BUPIVACAINE HYDROCHLORIDE

Application Number

70597

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

1987-03-03

Regulatory Status

RX

1987
03 Mar
RX Application: 70609

Drug Name

BUPIVACAINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

1987-03-03

70609 / 1

Active Ingredient

BUPIVACAINE HYDROCHLORIDE

Application Number

70609

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

1987-03-03

Regulatory Status

RX

1987
11 Dec
RX Application: 71810

Drug Name

BUPIVACAINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.75%

Approval Date

1987-12-11

71810 / 1

Active Ingredient

BUPIVACAINE HYDROCHLORIDE

Application Number

71810

Product Number

1

Dosage Form

-

Strength

0.75%

Approval Date

1987-12-11

Regulatory Status

RX

1983
13 Jul
Discontinued Application: 22046

Drug Name

BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE

Product Number

1

Dosage Form

-

Strength

0.5%;0.0091MG/ML

Approval Date

1983-07-13

22046 / 1

Active Ingredient

BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE

Application Number

22046

Product Number

1

Dosage Form

-

Strength

0.5%;0.0091MG/ML

Approval Date

1983-07-13

Regulatory Status

Discontinued

1988
16 Jun
RX Application: 71165

Drug Name

BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE

Product Number

1

Dosage Form

-

Strength

0.25%;0.005MG/ML

Approval Date

1988-06-16

71165 / 1

Active Ingredient

BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE

Application Number

71165

Product Number

1

Dosage Form

-

Strength

0.25%;0.005MG/ML

Approval Date

1988-06-16

Regulatory Status

RX

1988
16 Jun
Discontinued Application: 71166

Drug Name

BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE

Product Number

1

Dosage Form

-

Strength

0.25%;0.005MG/ML

Approval Date

1988-06-16

71166 / 1

Active Ingredient

BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE

Application Number

71166

Product Number

1

Dosage Form

-

Strength

0.25%;0.005MG/ML

Approval Date

1988-06-16

Regulatory Status

Discontinued

1988
16 Jun
RX Application: 71167

Drug Name

BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE

Product Number

1

Dosage Form

-

Strength

0.25%;0.005MG/ML

Approval Date

1988-06-16

71167 / 1

Active Ingredient

BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE

Application Number

71167

Product Number

1

Dosage Form

-

Strength

0.25%;0.005MG/ML

Approval Date

1988-06-16

Regulatory Status

RX

1988
16 Jun
RX Application: 71168

Drug Name

BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE

Product Number

1

Dosage Form

-

Strength

0.5%;0.005MG/ML

Approval Date

1988-06-16

71168 / 1

Active Ingredient

BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE

Application Number

71168

Product Number

1

Dosage Form

-

Strength

0.5%;0.005MG/ML

Approval Date

1988-06-16

Regulatory Status

RX

1988
16 Jun
Discontinued Application: 71169

Drug Name

BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE

Product Number

1

Dosage Form

-

Strength

0.5%;0.005MG/ML

Approval Date

1988-06-16

71169 / 1

Active Ingredient

BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE

Application Number

71169

Product Number

1

Dosage Form

-

Strength

0.5%;0.005MG/ML

Approval Date

1988-06-16

Regulatory Status

Discontinued

1988
16 Jun
RX Application: 71170

Drug Name

BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE

Product Number

1

Dosage Form

-

Strength

0.5%;0.005MG/ML

Approval Date

1988-06-16

71170 / 1

Active Ingredient

BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE

Application Number

71170

Product Number

1

Dosage Form

-

Strength

0.5%;0.005MG/ML

Approval Date

1988-06-16

Regulatory Status

RX

1988
16 Jun
Discontinued Application: 71171

Drug Name

BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE

Product Number

1

Dosage Form

-

Strength

0.75%;0.005MG/ML

Approval Date

1988-06-16

71171 / 1

Active Ingredient

BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE

Application Number

71171

Product Number

1

Dosage Form

-

Strength

0.75%;0.005MG/ML

Approval Date

1988-06-16

Regulatory Status

Discontinued

1992
03 Sep
Discontinued Application: 19978

Drug Name

BUPIVACAINE HYDROCHLORIDE KIT

Product Number

1

Dosage Form

-

Strength

0.075%

Approval Date

1992-09-03

19978 / 1

Active Ingredient

BUPIVACAINE HYDROCHLORIDE

Application Number

19978

Product Number

1

Dosage Form

-

Strength

0.075%

Approval Date

1992-09-03

Regulatory Status

Discontinued

1992
03 Sep
Discontinued Application: 19978

Drug Name

BUPIVACAINE HYDROCHLORIDE KIT

Product Number

2

Dosage Form

-

Strength

0.114%

Approval Date

1992-09-03

19978 / 2

Active Ingredient

BUPIVACAINE HYDROCHLORIDE

Application Number

19978

Product Number

2

Dosage Form

-

Strength

0.114%

Approval Date

1992-09-03

Regulatory Status

Discontinued

1992
03 Sep
Discontinued Application: 19978

Drug Name

BUPIVACAINE HYDROCHLORIDE KIT

Product Number

3

Dosage Form

-

Strength

0.23%

Approval Date

1992-09-03

19978 / 3

Active Ingredient

BUPIVACAINE HYDROCHLORIDE

Application Number

19978

Product Number

3

Dosage Form

-

Strength

0.23%

Approval Date

1992-09-03

Regulatory Status

Discontinued

1996
03 Jun
RX Application: 74137

Drug Name

BUPRENORPHINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 0.3MG BASE/ML

Approval Date

1996-06-03

74137 / 1

Active Ingredient

BUPRENORPHINE HYDROCHLORIDE

Application Number

74137

Product Number

1

Dosage Form

-

Strength

EQ 0.3MG BASE/ML

Approval Date

1996-06-03

Regulatory Status

RX

2018
31 Jul
RX Application: 205672

Drug Name

BUSULFAN

Product Number

1

Dosage Form

-

Strength

6MG/ML

Approval Date

2018-07-31

205672 / 1

Active Ingredient

BUSULFAN

Application Number

205672

Product Number

1

Dosage Form

-

Strength

6MG/ML

Approval Date

2018-07-31

Regulatory Status

RX

1999
04 Nov
Discontinued Application: 75342

Drug Name

BUTORPHANOL TARTRATE

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

1999-11-04

75342 / 1

Active Ingredient

BUTORPHANOL TARTRATE

Application Number

75342

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

1999-11-04

Regulatory Status

Discontinued

1999
04 Nov
Discontinued Application: 75342

Drug Name

BUTORPHANOL TARTRATE

Product Number

2

Dosage Form

-

Strength

2MG/ML

Approval Date

1999-11-04

75342 / 2

Active Ingredient

BUTORPHANOL TARTRATE

Application Number

75342

Product Number

2

Dosage Form

-

Strength

2MG/ML

Approval Date

1999-11-04

Regulatory Status

Discontinued

2000
20 Mar
Discontinued Application: 75559

Drug Name

BUTORPHANOL TARTRATE

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2000-03-20

75559 / 1

Active Ingredient

BUTORPHANOL TARTRATE

Application Number

75559

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2000-03-20

Regulatory Status

Discontinued

2000
20 Mar
Discontinued Application: 75559

Drug Name

BUTORPHANOL TARTRATE

Product Number

2

Dosage Form

-

Strength

2MG/ML

Approval Date

2000-03-20

75559 / 2

Active Ingredient

BUTORPHANOL TARTRATE

Application Number

75559

Product Number

2

Dosage Form

-

Strength

2MG/ML

Approval Date

2000-03-20

Regulatory Status

Discontinued

1997
22 Jan
Discontinued Application: 74620

Drug Name

BUTORPHANOL TARTRATE PRESERVATIVE FREE

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

1997-01-22

74620 / 1

Active Ingredient

BUTORPHANOL TARTRATE

Application Number

74620

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

1997-01-22

Regulatory Status

Discontinued

1997
22 Jan
Discontinued Application: 74620

Drug Name

BUTORPHANOL TARTRATE PRESERVATIVE FREE

Product Number

2

Dosage Form

-

Strength

2MG/ML

Approval Date

1997-01-22

74620 / 2

Active Ingredient

BUTORPHANOL TARTRATE

Application Number

74620

Product Number

2

Dosage Form

-

Strength

2MG/ML

Approval Date

1997-01-22

Regulatory Status

Discontinued

1997
23 Jan
RX Application: 74626

Drug Name

BUTORPHANOL TARTRATE PRESERVATIVE FREE

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

1997-01-23

74626 / 1

Active Ingredient

BUTORPHANOL TARTRATE

Application Number

74626

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

1997-01-23

Regulatory Status

RX

1997
23 Jan
RX Application: 74626

Drug Name

BUTORPHANOL TARTRATE PRESERVATIVE FREE

Product Number

2

Dosage Form

-

Strength

2MG/ML

Approval Date

1997-01-23

74626 / 2

Active Ingredient

BUTORPHANOL TARTRATE

Application Number

74626

Product Number

2

Dosage Form

-

Strength

2MG/ML

Approval Date

1997-01-23

Regulatory Status

RX

1998
28 Sep
Discontinued Application: 75170

Drug Name

BUTORPHANOL TARTRATE PRESERVATIVE FREE

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

1998-09-28

75170 / 1

Active Ingredient

BUTORPHANOL TARTRATE

Application Number

75170

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

1998-09-28

Regulatory Status

Discontinued

1998
28 Sep
Discontinued Application: 75170

Drug Name

BUTORPHANOL TARTRATE PRESERVATIVE FREE

Product Number

2

Dosage Form

-

Strength

2MG/ML

Approval Date

1998-09-28

75170 / 2

Active Ingredient

BUTORPHANOL TARTRATE

Application Number

75170

Product Number

2

Dosage Form

-

Strength

2MG/ML

Approval Date

1998-09-28

Regulatory Status

Discontinued

2004
16 Jan
Discontinued Application: 75816

Drug Name

CALCITRIOL

Product Number

1

Dosage Form

-

Strength

0.001MG/ML

Approval Date

2004-01-16

75816 / 1

Active Ingredient

CALCITRIOL

Application Number

75816

Product Number

1

Dosage Form

-

Strength

0.001MG/ML

Approval Date

2004-01-16

Regulatory Status

Discontinued

2004
16 Jan
Discontinued Application: 75816

Drug Name

CALCITRIOL

Product Number

2

Dosage Form

-

Strength

0.002MG/ML

Approval Date

2004-01-16

75816 / 2

Active Ingredient

CALCITRIOL

Application Number

75816

Product Number

2

Dosage Form

-

Strength

0.002MG/ML

Approval Date

2004-01-16

Regulatory Status

Discontinued

2000
28 Jan
RX Application: 21117

Drug Name

CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2000-01-28

21117 / 1

Active Ingredient

CALCIUM CHLORIDE

Application Number

21117

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2000-01-28

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 12250

Drug Name

CARBOCAINE

Product Number

1

Dosage Form

-

Strength

1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

12250 / 1

Active Ingredient

MEPIVACAINE HYDROCHLORIDE

Application Number

12250

Product Number

1

Dosage Form

-

Strength

1% **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: 12250

Drug Name

CARBOCAINE

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1982-01-01

12250 / 2

Active Ingredient

MEPIVACAINE HYDROCHLORIDE

Application Number

12250

Product Number

2

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

1982
01 Jan
Discontinued Application: 12250

Drug Name

CARBOCAINE

Product Number

5

Dosage Form

-

Strength

1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

12250 / 5

Active Ingredient

MEPIVACAINE HYDROCHLORIDE

Application Number

12250

Product Number

5

Dosage Form

-

Strength

1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

2004
27 Oct
Discontinued Application: 76473

Drug Name

CARBOPLATIN

Product Number

1

Dosage Form

-

Strength

50MG/VIAL

Approval Date

2004-10-27

76473 / 1

Active Ingredient

CARBOPLATIN

Application Number

76473

Product Number

1

Dosage Form

-

Strength

50MG/VIAL

Approval Date

2004-10-27

Regulatory Status

Discontinued

2004
27 Oct
Discontinued Application: 76473

Drug Name

CARBOPLATIN

Product Number

2

Dosage Form

-

Strength

150MG/VIAL

Approval Date

2004-10-27

76473 / 2

Active Ingredient

CARBOPLATIN

Application Number

76473

Product Number

2

Dosage Form

-

Strength

150MG/VIAL

Approval Date

2004-10-27

Regulatory Status

Discontinued

2004
27 Oct
Discontinued Application: 76473

Drug Name

CARBOPLATIN

Product Number

3

Dosage Form

-

Strength

450MG/VIAL

Approval Date

2004-10-27

76473 / 3

Active Ingredient

CARBOPLATIN

Application Number

76473

Product Number

3

Dosage Form

-

Strength

450MG/VIAL

Approval Date

2004-10-27

Regulatory Status

Discontinued

2004
14 Oct
RX Application: 76517

Drug Name

CARBOPLATIN

Product Number

1

Dosage Form

-

Strength

50MG/5ML (10MG/ML)

Approval Date

2004-10-14

76517 / 1

Active Ingredient

CARBOPLATIN

Application Number

76517

Product Number

1

Dosage Form

-

Strength

50MG/5ML (10MG/ML)

Approval Date

2004-10-14

Regulatory Status

RX

2004
14 Oct
RX Application: 76517

Drug Name

CARBOPLATIN

Product Number

2

Dosage Form

-

Strength

150MG/15ML (10MG/ML)

Approval Date

2004-10-14

76517 / 2

Active Ingredient

CARBOPLATIN

Application Number

76517

Product Number

2

Dosage Form

-

Strength

150MG/15ML (10MG/ML)

Approval Date

2004-10-14

Regulatory Status

RX

2004
14 Oct
RX Application: 76517

Drug Name

CARBOPLATIN

Product Number

3

Dosage Form

-

Strength

450MG/45ML (10MG/ML)

Approval Date

2004-10-14

76517 / 3

Active Ingredient

CARBOPLATIN

Application Number

76517

Product Number

3

Dosage Form

-

Strength

450MG/45ML (10MG/ML)

Approval Date

2004-10-14

Regulatory Status

RX

2004
23 Nov
RX Application: 77059

Drug Name

CARBOPLATIN

Product Number

1

Dosage Form

-

Strength

600MG/60ML (10MG/ML)

Approval Date

2004-11-23

77059 / 1

Active Ingredient

CARBOPLATIN

Application Number

77059

Product Number

1

Dosage Form

-

Strength

600MG/60ML (10MG/ML)

Approval Date

2004-11-23

Regulatory Status

RX

2005
21 Apr
Discontinued Application: 65226

Drug Name

CEFAZOLIN SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2005-04-21

65226 / 1

Active Ingredient

CEFAZOLIN SODIUM

Application Number

65226

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2005-04-21

Regulatory Status

Discontinued

2005
21 Apr
Discontinued Application: 65226

Drug Name

CEFAZOLIN SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2005-04-21

65226 / 2

Active Ingredient

CEFAZOLIN SODIUM

Application Number

65226

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2005-04-21

Regulatory Status

Discontinued

2005
12 Aug
Discontinued Application: 65244

Drug Name

CEFAZOLIN SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2005-08-12

65244 / 1

Active Ingredient

CEFAZOLIN SODIUM

Application Number

65244

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2005-08-12

Regulatory Status

Discontinued

2005
12 Aug
Discontinued Application: 65247

Drug Name

CEFAZOLIN SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 10GM BASE/VIAL

Approval Date

2005-08-12

65247 / 1

Active Ingredient

CEFAZOLIN SODIUM

Application Number

65247

Product Number

1

Dosage Form

-

Strength

EQ 10GM BASE/VIAL

Approval Date

2005-08-12

Regulatory Status

Discontinued

2016
03 Feb
Discontinued Application: 201654

Drug Name

CEFAZOLIN SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2016-02-03

201654 / 1

Active Ingredient

CEFAZOLIN SODIUM

Application Number

201654

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2016-02-03

Regulatory Status

Discontinued

2007
18 Jun
Discontinued Application: 65369

Drug Name

CEFEPIME HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2007-06-18

65369 / 1

Active Ingredient

CEFEPIME HYDROCHLORIDE

Application Number

65369

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2007-06-18

Regulatory Status

Discontinued

2007
18 Jun
Discontinued Application: 65369

Drug Name

CEFEPIME HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2007-06-18

65369 / 2

Active Ingredient

CEFEPIME HYDROCHLORIDE

Application Number

65369

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2007-06-18

Regulatory Status

Discontinued

2007
18 Jun
Discontinued Application: 65369

Drug Name

CEFEPIME HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

2007-06-18

65369 / 3

Active Ingredient

CEFEPIME HYDROCHLORIDE

Application Number

65369

Product Number

3

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

2007-06-18

Regulatory Status

Discontinued

2012
30 Jul
Discontinued Application: 202268

Drug Name

CEFEPIME HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2012-07-30

202268 / 1

Active Ingredient

CEFEPIME HYDROCHLORIDE

Application Number

202268

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2012-07-30

Regulatory Status

Discontinued

2012
30 Jul
Discontinued Application: 202268

Drug Name

CEFEPIME HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

2012-07-30

202268 / 2

Active Ingredient

CEFEPIME HYDROCHLORIDE

Application Number

202268

Product Number

2

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

2012-07-30

Regulatory Status

Discontinued

2006
11 Aug
Discontinued Application: 65290

Drug Name

CEFOTAXIME SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2006-08-11

65290 / 1

Active Ingredient

CEFOTAXIME SODIUM

Application Number

65290

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2006-08-11

Regulatory Status

Discontinued

2006
11 Aug
Discontinued Application: 65290

Drug Name

CEFOTAXIME SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2006-08-11

65290 / 2

Active Ingredient

CEFOTAXIME SODIUM

Application Number

65290

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2006-08-11

Regulatory Status

Discontinued

2006
11 Aug
Discontinued Application: 65290

Drug Name

CEFOTAXIME SODIUM

Product Number

3

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

2006-08-11

65290 / 3

Active Ingredient

CEFOTAXIME SODIUM

Application Number

65290

Product Number

3

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

2006-08-11

Regulatory Status

Discontinued

2006
10 Aug
Discontinued Application: 65292

Drug Name

CEFOTAXIME SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 10GM BASE/VIAL

Approval Date

2006-08-10

65292 / 1

Active Ingredient

CEFOTAXIME SODIUM

Application Number

65292

Product Number

1

Dosage Form

-

Strength

EQ 10GM BASE/VIAL

Approval Date

2006-08-10

Regulatory Status

Discontinued

2006
10 Aug
Discontinued Application: 65293

Drug Name

CEFOTAXIME SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2006-08-10

65293 / 1

Active Ingredient

CEFOTAXIME SODIUM

Application Number

65293

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2006-08-10

Regulatory Status

Discontinued

2006
10 Aug
Discontinued Application: 65293

Drug Name

CEFOTAXIME SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

2006-08-10

65293 / 2

Active Ingredient

CEFOTAXIME SODIUM

Application Number

65293

Product Number

2

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

2006-08-10

Regulatory Status

Discontinued

2016
19 Feb
Discontinued Application: 203132

Drug Name

CEFOTAXIME SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2016-02-19

203132 / 1

Active Ingredient

CEFOTAXIME SODIUM

Application Number

203132

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2016-02-19

Regulatory Status

Discontinued

2016
19 Feb
Discontinued Application: 203132

Drug Name

CEFOTAXIME SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

2016-02-19

203132 / 2

Active Ingredient

CEFOTAXIME SODIUM

Application Number

203132

Product Number

2

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

2016-02-19

Regulatory Status

Discontinued

2006
13 Feb
Discontinued Application: 65312

Drug Name

CEFOXITIN

Product Number

1

Dosage Form

-

Strength

EQ 10GM BASE/VIAL

Approval Date

2006-02-13

65312 / 1

Active Ingredient

CEFOXITIN SODIUM

Application Number

65312

Product Number

1

Dosage Form

-

Strength

EQ 10GM BASE/VIAL

Approval Date

2006-02-13

Regulatory Status

Discontinued

2006
23 Jan
Discontinued Application: 65313

Drug Name

CEFOXITIN

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2006-01-23

65313 / 1

Active Ingredient

CEFOXITIN SODIUM

Application Number

65313

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2006-01-23

Regulatory Status

Discontinued

2006
23 Jan
Discontinued Application: 65313

Drug Name

CEFOXITIN

Product Number

2

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

2006-01-23

65313 / 2

Active Ingredient

CEFOXITIN SODIUM

Application Number

65313

Product Number

2

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

2006-01-23

Regulatory Status

Discontinued

2005
02 Aug
Discontinued Application: 65230

Drug Name

CEFTRIAXONE

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE/VIAL

Approval Date

2005-08-02

65230 / 1

Active Ingredient

CEFTRIAXONE SODIUM

Application Number

65230

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE/VIAL

Approval Date

2005-08-02

Regulatory Status

Discontinued

2005
02 Aug
Discontinued Application: 65230

Drug Name

CEFTRIAXONE

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2005-08-02

65230 / 2

Active Ingredient

CEFTRIAXONE SODIUM

Application Number

65230

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2005-08-02

Regulatory Status

Discontinued

2005
02 Aug
Discontinued Application: 65230

Drug Name

CEFTRIAXONE

Product Number

3

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2005-08-02

65230 / 3

Active Ingredient

CEFTRIAXONE SODIUM

Application Number

65230

Product Number

3

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2005-08-02

Regulatory Status

Discontinued

2005
02 Aug
Discontinued Application: 65230

Drug Name

CEFTRIAXONE

Product Number

4

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

2005-08-02

65230 / 4

Active Ingredient

CEFTRIAXONE SODIUM

Application Number

65230

Product Number

4

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

2005-08-02

Regulatory Status

Discontinued

2005
02 Aug
Discontinued Application: 65231

Drug Name

CEFTRIAXONE

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2005-08-02

65231 / 1

Active Ingredient

CEFTRIAXONE SODIUM

Application Number

65231

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2005-08-02

Regulatory Status

Discontinued

2005
02 Aug
Discontinued Application: 65231

Drug Name

CEFTRIAXONE

Product Number

2

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

2005-08-02

65231 / 2

Active Ingredient

CEFTRIAXONE SODIUM

Application Number

65231

Product Number

2

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

2005-08-02

Regulatory Status

Discontinued

2005
02 Aug
Discontinued Application: 65232

Drug Name

CEFTRIAXONE

Product Number

1

Dosage Form

-

Strength

EQ 10GM BASE/VIAL

Approval Date

2005-08-02

65232 / 1

Active Ingredient

CEFTRIAXONE SODIUM

Application Number

65232

Product Number

1

Dosage Form

-

Strength

EQ 10GM BASE/VIAL

Approval Date

2005-08-02

Regulatory Status

Discontinued

2012
20 Aug
Discontinued Application: 202563

Drug Name

CEFTRIAXONE

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2012-08-20

202563 / 1

Active Ingredient

CEFTRIAXONE SODIUM

Application Number

202563

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2012-08-20

Regulatory Status

Discontinued

2012
20 Aug
Discontinued Application: 202563

Drug Name

CEFTRIAXONE

Product Number

2

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

2012-08-20

202563 / 2

Active Ingredient

CEFTRIAXONE SODIUM

Application Number

202563

Product Number

2

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

2012-08-20

Regulatory Status

Discontinued

2008
15 Oct
Discontinued Application: 65483

Drug Name

CEFUROXIME SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 750MG BASE/VIAL

Approval Date

2008-10-15

65483 / 1

Active Ingredient

CEFUROXIME SODIUM

Application Number

65483

Product Number

1

Dosage Form

-

Strength

EQ 750MG BASE/VIAL

Approval Date

2008-10-15

Regulatory Status

Discontinued

2008
15 Oct
Discontinued Application: 65483

Drug Name

CEFUROXIME SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 1.5GM BASE/VIAL

Approval Date

2008-10-15

65483 / 2

Active Ingredient

CEFUROXIME SODIUM

Application Number

65483

Product Number

2

Dosage Form

-

Strength

EQ 1.5GM BASE/VIAL

Approval Date

2008-10-15

Regulatory Status

Discontinued

2008
15 Oct
Discontinued Application: 65484

Drug Name

CEFUROXIME SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 7.5GM BASE/VIAL

Approval Date

2008-10-15

65484 / 1

Active Ingredient

CEFUROXIME SODIUM

Application Number

65484

Product Number

1

Dosage Form

-

Strength

EQ 7.5GM BASE/VIAL

Approval Date

2008-10-15

Regulatory Status

Discontinued

2008
15 Oct
Discontinued Application: 65503

Drug Name

CEFUROXIME SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 1.5GM BASE/VIAL

Approval Date

2008-10-15

65503 / 1

Active Ingredient

CEFUROXIME SODIUM

Application Number

65503

Product Number

1

Dosage Form

-

Strength

EQ 1.5GM BASE/VIAL

Approval Date

2008-10-15

Regulatory Status

Discontinued

1982
16 Apr
Discontinued Application: 87446

Drug Name

CHLOROPROCAINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

3%

Approval Date

1982-04-16

87446 / 1

Active Ingredient

CHLOROPROCAINE HYDROCHLORIDE

Application Number

87446

Product Number

1

Dosage Form

-

Strength

3%

Approval Date

1982-04-16

Regulatory Status

Discontinued

1982
16 Apr
Discontinued Application: 87447

Drug Name

CHLOROPROCAINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1982-04-16

87447 / 1

Active Ingredient

CHLOROPROCAINE HYDROCHLORIDE

Application Number

87447

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1982-04-16

Regulatory Status

Discontinued

1986
26 Jun
RX Application: 18961

Drug Name

CHROMIC CHLORIDE IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

EQ 0.004MG CHROMIUM/ML

Approval Date

1986-06-26

18961 / 1

Active Ingredient

CHROMIC CHLORIDE

Application Number

18961

Product Number

1

Dosage Form

-

Strength

EQ 0.004MG CHROMIUM/ML

Approval Date

1986-06-26

Regulatory Status

RX

1997
28 Mar
Discontinued Application: 74296

Drug Name

CIMETIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 300MG BASE/2ML

Approval Date

1997-03-28

74296 / 1

Active Ingredient

CIMETIDINE HYDROCHLORIDE

Application Number

74296

Product Number

1

Dosage Form

-

Strength

EQ 300MG BASE/2ML

Approval Date

1997-03-28

Regulatory Status

Discontinued

1995
31 Jan
Discontinued Application: 74344

Drug Name

CIMETIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 300MG BASE/2ML

Approval Date

1995-01-31

74344 / 1

Active Ingredient

CIMETIDINE HYDROCHLORIDE

Application Number

74344

Product Number

1

Dosage Form

-

Strength

EQ 300MG BASE/2ML

Approval Date

1995-01-31

Regulatory Status

Discontinued

1995
31 Jan
Discontinued Application: 74345

Drug Name

CIMETIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 300MG BASE/2ML

Approval Date

1995-01-31

74345 / 1

Active Ingredient

CIMETIDINE HYDROCHLORIDE

Application Number

74345

Product Number

1

Dosage Form

-

Strength

EQ 300MG BASE/2ML

Approval Date

1995-01-31

Regulatory Status

Discontinued

1997
28 Mar
Discontinued Application: 74412

Drug Name

CIMETIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 300MG BASE/2ML

Approval Date

1997-03-28

74412 / 1

Active Ingredient

CIMETIDINE HYDROCHLORIDE

Application Number

74412

Product Number

1

Dosage Form

-

Strength

EQ 300MG BASE/2ML

Approval Date

1997-03-28

Regulatory Status

Discontinued

1995
31 Jan
Discontinued Application: 74422

Drug Name

CIMETIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 300MG BASE/2ML

Approval Date

1995-01-31

74422 / 1

Active Ingredient

CIMETIDINE HYDROCHLORIDE

Application Number

74422

Product Number

1

Dosage Form

-

Strength

EQ 300MG BASE/2ML

Approval Date

1995-01-31

Regulatory Status

Discontinued

1994
27 Dec
Discontinued Application: 74269

Drug Name

CIMETIDINE HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

EQ 6MG BASE/ML

Approval Date

1994-12-27

74269 / 1

Active Ingredient

CIMETIDINE HYDROCHLORIDE

Application Number

74269

Product Number

1

Dosage Form

-

Strength

EQ 6MG BASE/ML

Approval Date

1994-12-27

Regulatory Status

Discontinued

1994
29 Dec
Discontinued Application: 74468

Drug Name

CIMETIDINE HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

EQ 360MG BASE/100ML

Approval Date

1994-12-29

74468 / 1

Active Ingredient

CIMETIDINE HYDROCHLORIDE

Application Number

74468

Product Number

1

Dosage Form

-

Strength

EQ 360MG BASE/100ML

Approval Date

1994-12-29

Regulatory Status

Discontinued

1994
29 Dec
Discontinued Application: 74468

Drug Name

CIMETIDINE HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

EQ 480MG BASE/100ML

Approval Date

1994-12-29

74468 / 2

Active Ingredient

CIMETIDINE HYDROCHLORIDE

Application Number

74468

Product Number

2

Dosage Form

-

Strength

EQ 480MG BASE/100ML

Approval Date

1994-12-29

Regulatory Status

Discontinued

1994
29 Dec
Discontinued Application: 74468

Drug Name

CIMETIDINE HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

3

Dosage Form

-

Strength

EQ 180MG BASE/100ML

Approval Date

1994-12-29

74468 / 3

Active Ingredient

CIMETIDINE HYDROCHLORIDE

Application Number

74468

Product Number

3

Dosage Form

-

Strength

EQ 180MG BASE/100ML

Approval Date

1994-12-29

Regulatory Status

Discontinued

1994
29 Dec
Discontinued Application: 74468

Drug Name

CIMETIDINE HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

4

Dosage Form

-

Strength

EQ 240MG BASE/100ML

Approval Date

1994-12-29

74468 / 4

Active Ingredient

CIMETIDINE HYDROCHLORIDE

Application Number

74468

Product Number

4

Dosage Form

-

Strength

EQ 240MG BASE/100ML

Approval Date

1994-12-29

Regulatory Status

Discontinued

1994
29 Dec
Discontinued Application: 74468

Drug Name

CIMETIDINE HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

5

Dosage Form

-

Strength

EQ 90MG BASE/100ML

Approval Date

1994-12-29

74468 / 5

Active Ingredient

CIMETIDINE HYDROCHLORIDE

Application Number

74468

Product Number

5

Dosage Form

-

Strength

EQ 90MG BASE/100ML

Approval Date

1994-12-29

Regulatory Status

Discontinued

1994
29 Dec
Discontinued Application: 74468

Drug Name

CIMETIDINE HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

6

Dosage Form

-

Strength

EQ 120MG BASE/100ML

Approval Date

1994-12-29

74468 / 6

Active Ingredient

CIMETIDINE HYDROCHLORIDE

Application Number

74468

Product Number

6

Dosage Form

-

Strength

EQ 120MG BASE/100ML

Approval Date

1994-12-29

Regulatory Status

Discontinued

2006
28 Aug
Discontinued Application: 77245

Drug Name

CIPROFLOXACIN

Product Number

1

Dosage Form

-

Strength

200MG/20ML (10MG/ML)

Approval Date

2006-08-28

77245 / 1

Active Ingredient

CIPROFLOXACIN

Application Number

77245

Product Number

1

Dosage Form

-

Strength

200MG/20ML (10MG/ML)

Approval Date

2006-08-28

Regulatory Status

Discontinued

2006
28 Aug
Discontinued Application: 77245

Drug Name

CIPROFLOXACIN

Product Number

2

Dosage Form

-

Strength

400MG/40ML (10MG/ML)

Approval Date

2006-08-28

77245 / 2

Active Ingredient

CIPROFLOXACIN

Application Number

77245

Product Number

2

Dosage Form

-

Strength

400MG/40ML (10MG/ML)

Approval Date

2006-08-28

Regulatory Status

Discontinued

2008
18 Mar
RX Application: 77753

Drug Name

CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

200MG/100ML

Approval Date

2008-03-18

77753 / 1

Active Ingredient

CIPROFLOXACIN

Application Number

77753

Product Number

1

Dosage Form

-

Strength

200MG/100ML

Approval Date

2008-03-18

Regulatory Status

RX

2008
18 Mar
RX Application: 77753

Drug Name

CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

400MG/200ML

Approval Date

2008-03-18

77753 / 2

Active Ingredient

CIPROFLOXACIN

Application Number

77753

Product Number

2

Dosage Form

-

Strength

400MG/200ML

Approval Date

2008-03-18

Regulatory Status

RX

2018
30 Mar
RX Application: 203236

Drug Name

CISATRACURIUM BESYLATE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2018-03-30

203236 / 1

Active Ingredient

CISATRACURIUM BESYLATE

Application Number

203236

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2018-03-30

Regulatory Status

RX

2018
30 Mar
RX Application: 203236

Drug Name

CISATRACURIUM BESYLATE

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

2018-03-30

203236 / 2

Active Ingredient

CISATRACURIUM BESYLATE

Application Number

203236

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

2018-03-30

Regulatory Status

RX

2018
30 Mar
RX Application: 203238

Drug Name

CISATRACURIUM BESYLATE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2018-03-30

203238 / 1

Active Ingredient

CISATRACURIUM BESYLATE

Application Number

203238

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2018-03-30

Regulatory Status

RX

2018
27 Dec
Discontinued Application: 210283

Drug Name

CLOFARABINE

Product Number

1

Dosage Form

-

Strength

20MG/20ML (1MG/ML)

Approval Date

2018-12-27

210283 / 1

Active Ingredient

CLOFARABINE

Application Number

210283

Product Number

1

Dosage Form

-

Strength

20MG/20ML (1MG/ML)

Approval Date

2018-12-27

Regulatory Status

Discontinued

1997
23 Sep
Discontinued Application: 19922

Drug Name

CORLOPAM

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1997-09-23

19922 / 1

Active Ingredient

FENOLDOPAM MESYLATE

Application Number

19922

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1997-09-23

Regulatory Status

Discontinued

1986
26 Jun
RX Application: 18960

Drug Name

CUPRIC CHLORIDE IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

EQ 0.4MG COPPER/ML

Approval Date

1986-06-26

18960 / 1

Active Ingredient

CUPRIC CHLORIDE

Application Number

18960

Product Number

1

Dosage Form

-

Strength

EQ 0.4MG COPPER/ML

Approval Date

1986-06-26

Regulatory Status

RX

1986
22 Oct
Discontinued Application: 19523

Drug Name

CYSTEINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

7.25% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1986-10-22

19523 / 1

Active Ingredient

CYSTEINE HYDROCHLORIDE

Application Number

19523

Product Number

1

Dosage Form

-

Strength

7.25% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1986-10-22

Regulatory Status

Discontinued

1990
04 Jun
RX Application: 71868

Drug Name

CYTARABINE

Product Number

1

Dosage Form

-

Strength

20MG/ML

Approval Date

1990-06-04

71868 / 1

Active Ingredient

CYTARABINE

Application Number

71868

Product Number

1

Dosage Form

-

Strength

20MG/ML

Approval Date

1990-06-04

Regulatory Status

RX

1990
31 Aug
RX Application: 72168

Drug Name

CYTARABINE

Product Number

1

Dosage Form

-

Strength

20MG/ML

Approval Date

1990-08-31

72168 / 1

Active Ingredient

CYTARABINE

Application Number

72168

Product Number

1

Dosage Form

-

Strength

20MG/ML

Approval Date

1990-08-31

Regulatory Status

RX

1994
28 Feb
RX Application: 72945

Drug Name

CYTARABINE

Product Number

1

Dosage Form

-

Strength

20MG/ML

Approval Date

1994-02-28

72945 / 1

Active Ingredient

CYTARABINE

Application Number

72945

Product Number

1

Dosage Form

-

Strength

20MG/ML

Approval Date

1994-02-28

Regulatory Status

RX

1999
22 Nov
RX Application: 75383

Drug Name

CYTARABINE

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

1999-11-22

75383 / 1

Active Ingredient

CYTARABINE

Application Number

75383

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

1999-11-22

Regulatory Status

RX

2001
18 Oct
Discontinued Application: 75940

Drug Name

DACARBAZINE

Product Number

1

Dosage Form

-

Strength

200MG/VIAL

Approval Date

2001-10-18

75940 / 1

Active Ingredient

DACARBAZINE

Application Number

75940

Product Number

1

Dosage Form

-

Strength

200MG/VIAL

Approval Date

2001-10-18

Regulatory Status

Discontinued

2014
12 Sep
Discontinued Application: 202857

Drug Name

DAPTOMYCIN

Product Number

1

Dosage Form

-

Strength

500MG/VIAL

Approval Date

2014-09-12

202857 / 1

Active Ingredient

DAPTOMYCIN

Application Number

202857

Product Number

1

Dosage Form

-

Strength

500MG/VIAL

Approval Date

2014-09-12

Regulatory Status

Discontinued

-
Unclassified Application: 203797

Drug Name

DAPTOMYCIN

Product Number

1

Dosage Form

-

Strength

350MG/VIAL

Approval Date

-

203797 / 1

Active Ingredient

DAPTOMYCIN

Application Number

203797

Product Number

1

Dosage Form

-

Strength

350MG/VIAL

Approval Date

-

Regulatory Status

Unclassified

2021
21 Jun
RX Application: 210282

Drug Name

DAPTOMYCIN

Product Number

1

Dosage Form

-

Strength

350MG/VIAL

Approval Date

2021-06-21

210282 / 1

Active Ingredient

DAPTOMYCIN

Application Number

210282

Product Number

1

Dosage Form

-

Strength

350MG/VIAL

Approval Date

2021-06-21

Regulatory Status

RX

2021
21 Jun
RX Application: 210282

Drug Name

DAPTOMYCIN

Product Number

2

Dosage Form

-

Strength

500MG/VIAL

Approval Date

2021-06-21

210282 / 2

Active Ingredient

DAPTOMYCIN

Application Number

210282

Product Number

2

Dosage Form

-

Strength

500MG/VIAL

Approval Date

2021-06-21

Regulatory Status

RX

2004
17 Mar
RX Application: 76019

Drug Name

DEFEROXAMINE MESYLATE

Product Number

1

Dosage Form

-

Strength

500MG/VIAL

Approval Date

2004-03-17

76019 / 1

Active Ingredient

DEFEROXAMINE MESYLATE

Application Number

76019

Product Number

1

Dosage Form

-

Strength

500MG/VIAL

Approval Date

2004-03-17

Regulatory Status

RX

2004
17 Mar
RX Application: 76019

Drug Name

DEFEROXAMINE MESYLATE

Product Number

2

Dosage Form

-

Strength

2GM/VIAL

Approval Date

2004-03-17

76019 / 2

Active Ingredient

DEFEROXAMINE MESYLATE

Application Number

76019

Product Number

2

Dosage Form

-

Strength

2GM/VIAL

Approval Date

2004-03-17

Regulatory Status

RX

1982
01 Jan
RX Application: 21171

Drug Name

DEMEROL

Product Number

1

Dosage Form

-

Strength

25MG/ML

Approval Date

1982-01-01

21171 / 1

Active Ingredient

MEPERIDINE HYDROCHLORIDE

Application Number

21171

Product Number

1

Dosage Form

-

Strength

25MG/ML

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 21171

Drug Name

DEMEROL

Product Number

2

Dosage Form

-

Strength

50MG/ML

Approval Date

1982-01-01

21171 / 2

Active Ingredient

MEPERIDINE HYDROCHLORIDE

Application Number

21171

Product Number

2

Dosage Form

-

Strength

50MG/ML

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 21171

Drug Name

DEMEROL

Product Number

3

Dosage Form

-

Strength

75MG/ML

Approval Date

1982-01-01

21171 / 3

Active Ingredient

MEPERIDINE HYDROCHLORIDE

Application Number

21171

Product Number

3

Dosage Form

-

Strength

75MG/ML

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 21171

Drug Name

DEMEROL

Product Number

4

Dosage Form

-

Strength

100MG/ML

Approval Date

1982-01-01

21171 / 4

Active Ingredient

MEPERIDINE HYDROCHLORIDE

Application Number

21171

Product Number

4

Dosage Form

-

Strength

100MG/ML

Approval Date

1982-01-01

Regulatory Status

RX

2000
28 Aug
Discontinued Application: 75220

Drug Name

DESMOPRESSIN ACETATE

Product Number

1

Dosage Form

-

Strength

0.004MG/ML

Approval Date

2000-08-28

75220 / 1

Active Ingredient

DESMOPRESSIN ACETATE

Application Number

75220

Product Number

1

Dosage Form

-

Strength

0.004MG/ML

Approval Date

2000-08-28

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 18096

Drug Name

DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

2.5GM/100ML;450MG/100ML

Approval Date

1982-01-01

18096 / 1

Active Ingredient

DEXTROSE; SODIUM CHLORIDE

Application Number

18096

Product Number

1

Dosage Form

-

Strength

2.5GM/100ML;450MG/100ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1998
23 Nov
RX Application: 19445

Drug Name

DEXTROSE 25%

Product Number

2

Dosage Form

-

Strength

250MG/ML

Approval Date

1998-11-23

19445 / 2

Active Ingredient

DEXTROSE

Application Number

19445

Product Number

2

Dosage Form

-

Strength

250MG/ML

Approval Date

1998-11-23

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 18254

Drug Name

DEXTROSE 5% AND RINGERS IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

33MG/100ML;5GM/100ML;30MG/100ML;860MG/100ML

Approval Date

1982-01-01

18254 / 1

Active Ingredient

CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

Application Number

18254

Product Number

1

Dosage Form

-

Strength

33MG/100ML;5GM/100ML;30MG/100ML;860MG/100ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1985
15 Jul
RX Application: 19466

Drug Name

DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

5GM/100ML

Approval Date

1985-07-15

19466 / 1

Active Ingredient

DEXTROSE

Application Number

19466

Product Number

1

Dosage Form

-

Strength

5GM/100ML

Approval Date

1985-07-15

Regulatory Status

RX

1985
17 Sep
RX Application: 19479

Drug Name

DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

5GM/100ML

Approval Date

1985-09-17

19479 / 1

Active Ingredient

DEXTROSE

Application Number

19479

Product Number

1

Dosage Form

-

Strength

5GM/100ML

Approval Date

1985-09-17

Regulatory Status

RX

1986
03 Jun
RX Application: 19445

Drug Name

DEXTROSE 50%

Product Number

1

Dosage Form

-

Strength

500MG/ML

Approval Date

1986-06-03

19445 / 1

Active Ingredient

DEXTROSE

Application Number

19445

Product Number

1

Dosage Form

-

Strength

500MG/ML

Approval Date

1986-06-03

Regulatory Status

RX

1985
25 Jan
Discontinued Application: 19346

Drug Name

DEXTROSE 60% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

60GM/100ML

Approval Date

1985-01-25

19346 / 1

Active Ingredient

DEXTROSE

Application Number

19346

Product Number

1

Dosage Form

-

Strength

60GM/100ML

Approval Date

1985-01-25

Regulatory Status

Discontinued

1987
13 Oct
RX Application: 71583

Drug Name

DIAZEPAM

Product Number

1

Dosage Form

-

Strength

50MG/10ML (5MG/ML)

Approval Date

1987-10-13

71583 / 1

Active Ingredient

DIAZEPAM

Application Number

71583

Product Number

1

Dosage Form

-

Strength

50MG/10ML (5MG/ML)

Approval Date

1987-10-13

Regulatory Status

RX

1987
13 Oct
Discontinued Application: 71584

Drug Name

DIAZEPAM

Product Number

1

Dosage Form

-

Strength

5MG/ML

Approval Date

1987-10-13

71584 / 1

Active Ingredient

DIAZEPAM

Application Number

71584

Product Number

1

Dosage Form

-

Strength

5MG/ML

Approval Date

1987-10-13

Regulatory Status

Discontinued

1988
20 Dec
RX Application: 72079

Drug Name

DIAZEPAM

Product Number

1

Dosage Form

-

Strength

10MG/2ML (5MG/ML)

Approval Date

1988-12-20

72079 / 1

Active Ingredient

DIAZEPAM

Application Number

72079

Product Number

1

Dosage Form

-

Strength

10MG/2ML (5MG/ML)

Approval Date

1988-12-20

Regulatory Status

RX

1996
16 May
Discontinued Application: 40093

Drug Name

DIGOXIN

Product Number

1

Dosage Form

-

Strength

0.25MG/ML

Approval Date

1996-05-16

40093 / 1

Active Ingredient

DIGOXIN

Application Number

40093

Product Number

1

Dosage Form

-

Strength

0.25MG/ML

Approval Date

1996-05-16

Regulatory Status

Discontinued

1998
28 Aug
Discontinued Application: 40206

Drug Name

DIGOXIN

Product Number

1

Dosage Form

-

Strength

0.25MG/ML

Approval Date

1998-08-28

40206 / 1

Active Ingredient

DIGOXIN

Application Number

40206

Product Number

1

Dosage Form

-

Strength

0.25MG/ML

Approval Date

1998-08-28

Regulatory Status

Discontinued

1996
25 Apr
Discontinued Application: 40092

Drug Name

DIGOXIN PEDIATRIC

Product Number

1

Dosage Form

-

Strength

0.1MG/ML

Approval Date

1996-04-25

40092 / 1

Active Ingredient

DIGOXIN

Application Number

40092

Product Number

1

Dosage Form

-

Strength

0.1MG/ML

Approval Date

1996-04-25

Regulatory Status

Discontinued

1998
15 Apr
Discontinued Application: 74941

Drug Name

DILTIAZEM HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG/ML

Approval Date

1998-04-15

74941 / 1

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

74941

Product Number

1

Dosage Form

-

Strength

5MG/ML

Approval Date

1998-04-15

Regulatory Status

Discontinued

2000
16 Feb
Discontinued Application: 75004

Drug Name

DILTIAZEM HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG/ML

Approval Date

2000-02-16

75004 / 1

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

75004

Product Number

1

Dosage Form

-

Strength

5MG/ML

Approval Date

2000-02-16

Regulatory Status

Discontinued

1999
29 Apr
Discontinued Application: 75106

Drug Name

DILTIAZEM HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG/ML

Approval Date

1999-04-29

75106 / 1

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

75106

Product Number

1

Dosage Form

-

Strength

5MG/ML

Approval Date

1999-04-29

Regulatory Status

Discontinued

2002
17 Dec
RX Application: 75853

Drug Name

DILTIAZEM HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG/VIAL

Approval Date

2002-12-17

75853 / 1

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

75853

Product Number

1

Dosage Form

-

Strength

100MG/VIAL

Approval Date

2002-12-17

Regulatory Status

RX

1998
20 Nov
Discontinued Application: 40140

Drug Name

DIPHENHYDRAMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

1998-11-20

40140 / 1

Active Ingredient

DIPHENHYDRAMINE HYDROCHLORIDE

Application Number

40140

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

1998-11-20

Regulatory Status

Discontinued

1997
19 Dec
Discontinued Application: 74601

Drug Name

DIPYRIDAMOLE

Product Number

1

Dosage Form

-

Strength

5MG/ML

Approval Date

1997-12-19

74601 / 1

Active Ingredient

DIPYRIDAMOLE

Application Number

74601

Product Number

1

Dosage Form

-

Strength

5MG/ML

Approval Date

1997-12-19

Regulatory Status

Discontinued

1993
29 Nov
RX Application: 74086

Drug Name

DOBUTAMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 12.5MG BASE/ML

Approval Date

1993-11-29

74086 / 1

Active Ingredient

DOBUTAMINE HYDROCHLORIDE

Application Number

74086

Product Number

1

Dosage Form

-

Strength

EQ 12.5MG BASE/ML

Approval Date

1993-11-29

Regulatory Status

RX

1995
16 Feb
Discontinued Application: 74292

Drug Name

DOBUTAMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 12.5MG BASE/ML

Approval Date

1995-02-16

74292 / 1

Active Ingredient

DOBUTAMINE HYDROCHLORIDE

Application Number

74292

Product Number

1

Dosage Form

-

Strength

EQ 12.5MG BASE/ML

Approval Date

1995-02-16

Regulatory Status

Discontinued

1996
27 Sep
Discontinued Application: 74634

Drug Name

DOBUTAMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 1.25GM BASE/100ML

Approval Date

1996-09-27

74634 / 1

Active Ingredient

DOBUTAMINE HYDROCHLORIDE

Application Number

74634

Product Number

1

Dosage Form

-

Strength

EQ 1.25GM BASE/100ML

Approval Date

1996-09-27

Regulatory Status

Discontinued

1993
19 Oct
Discontinued Application: 20269

Drug Name

DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5%

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/100ML

Approval Date

1993-10-19

20269 / 1

Active Ingredient

DOBUTAMINE HYDROCHLORIDE

Application Number

20269

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/100ML

Approval Date

1993-10-19

Regulatory Status

Discontinued

1993
19 Oct
Discontinued Application: 20269

Drug Name

DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5%

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE/100ML

Approval Date

1993-10-19

20269 / 2

Active Ingredient

DOBUTAMINE HYDROCHLORIDE

Application Number

20269

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE/100ML

Approval Date

1993-10-19

Regulatory Status

Discontinued

1993
19 Oct
Discontinued Application: 20269

Drug Name

DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5%

Product Number

3

Dosage Form

-

Strength

EQ 200MG BASE/100ML

Approval Date

1993-10-19

20269 / 3

Active Ingredient

DOBUTAMINE HYDROCHLORIDE

Application Number

20269

Product Number

3

Dosage Form

-

Strength

EQ 200MG BASE/100ML

Approval Date

1993-10-19

Regulatory Status

Discontinued

1993
19 Oct
RX Application: 20201

Drug Name

DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE/100ML

Approval Date

1993-10-19

20201 / 1

Active Ingredient

DOBUTAMINE HYDROCHLORIDE

Application Number

20201

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE/100ML

Approval Date

1993-10-19

Regulatory Status

RX

1993
19 Oct
RX Application: 20201

Drug Name

DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE/100ML

Approval Date

1993-10-19

20201 / 2

Active Ingredient

DOBUTAMINE HYDROCHLORIDE

Application Number

20201

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE/100ML

Approval Date

1993-10-19

Regulatory Status

RX

1993
19 Oct
RX Application: 20201

Drug Name

DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

3

Dosage Form

-

Strength

EQ 50MG BASE/100ML

Approval Date

1993-10-19

20201 / 3

Active Ingredient

DOBUTAMINE HYDROCHLORIDE

Application Number

20201

Product Number

3

Dosage Form

-

Strength

EQ 50MG BASE/100ML

Approval Date

1993-10-19

Regulatory Status

RX

1994
07 Jul
RX Application: 20201

Drug Name

DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

6

Dosage Form

-

Strength

EQ 400MG BASE/100ML

Approval Date

1994-07-07

20201 / 6

Active Ingredient

DOBUTAMINE HYDROCHLORIDE

Application Number

20201

Product Number

6

Dosage Form

-

Strength

EQ 400MG BASE/100ML

Approval Date

1994-07-07

Regulatory Status

RX

2011
08 Mar
RX Application: 22234

Drug Name

DOCETAXEL

Product Number

1

Dosage Form

-

Strength

20MG/2ML (10MG/ML)

Approval Date

2011-03-08

22234 / 1

Active Ingredient

DOCETAXEL

Application Number

22234

Product Number

1

Dosage Form

-

Strength

20MG/2ML (10MG/ML)

Approval Date

2011-03-08

Regulatory Status

RX

2011
08 Mar
RX Application: 22234

Drug Name

DOCETAXEL

Product Number

2

Dosage Form

-

Strength

80MG/8ML (10MG/ML)

Approval Date

2011-03-08

22234 / 2

Active Ingredient

DOCETAXEL

Application Number

22234

Product Number

2

Dosage Form

-

Strength

80MG/8ML (10MG/ML)

Approval Date

2011-03-08

Regulatory Status

RX

2011
08 Mar
RX Application: 22234

Drug Name

DOCETAXEL

Product Number

3

Dosage Form

-

Strength

160MG/16ML (10MG/ML)

Approval Date

2011-03-08

22234 / 3

Active Ingredient

DOCETAXEL

Application Number

22234

Product Number

3

Dosage Form

-

Strength

160MG/16ML (10MG/ML)

Approval Date

2011-03-08

Regulatory Status

RX

2016
23 Jun
RX Application: 22234

Drug Name

DOCETAXEL

Product Number

4

Dosage Form

-

Strength

20MG/ML (20MG/ML)

Approval Date

2016-06-23

22234 / 4

Active Ingredient

DOCETAXEL

Application Number

22234

Product Number

4

Dosage Form

-

Strength

20MG/ML (20MG/ML)

Approval Date

2016-06-23

Regulatory Status

RX

2016
23 Jun
RX Application: 22234

Drug Name

DOCETAXEL

Product Number

5

Dosage Form

-

Strength

80MG/4ML (20MG/ML)

Approval Date

2016-06-23

22234 / 5

Active Ingredient

DOCETAXEL

Application Number

22234

Product Number

5

Dosage Form

-

Strength

80MG/4ML (20MG/ML)

Approval Date

2016-06-23

Regulatory Status

RX

2016
23 Jun
Discontinued Application: 22234

Drug Name

DOCETAXEL

Product Number

6

Dosage Form

-

Strength

120MG/6ML (20MG/ML)

Approval Date

2016-06-23

22234 / 6

Active Ingredient

DOCETAXEL

Application Number

22234

Product Number

6

Dosage Form

-

Strength

120MG/6ML (20MG/ML)

Approval Date

2016-06-23

Regulatory Status

Discontinued

2017
24 Jan
RX Application: 22234

Drug Name

DOCETAXEL

Product Number

7

Dosage Form

-

Strength

160MG/8ML (20MG/ML)

Approval Date

2017-01-24

22234 / 7

Active Ingredient

DOCETAXEL

Application Number

22234

Product Number

7

Dosage Form

-

Strength

160MG/8ML (20MG/ML)

Approval Date

2017-01-24

Regulatory Status

RX

1982
01 Jan
RX Application: 18132

Drug Name

DOPAMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

40MG/ML

Approval Date

1982-01-01

18132 / 1

Active Ingredient

DOPAMINE HYDROCHLORIDE

Application Number

18132

Product Number

1

Dosage Form

-

Strength

40MG/ML

Approval Date

1982-01-01

Regulatory Status

RX

1982
04 Feb
RX Application: 18132

Drug Name

DOPAMINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

80MG/100ML

Approval Date

1982-02-04

18132 / 2

Active Ingredient

DOPAMINE HYDROCHLORIDE

Application Number

18132

Product Number

2

Dosage Form

-

Strength

80MG/100ML

Approval Date

1982-02-04

Regulatory Status

RX

1982
04 Feb
RX Application: 18132

Drug Name

DOPAMINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

160MG/100ML

Approval Date

1982-02-04

18132 / 3

Active Ingredient

DOPAMINE HYDROCHLORIDE

Application Number

18132

Product Number

3

Dosage Form

-

Strength

160MG/100ML

Approval Date

1982-02-04

Regulatory Status

RX

1982
09 Jul
RX Application: 18132

Drug Name

DOPAMINE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

80MG/ML

Approval Date

1982-07-09

18132 / 4

Active Ingredient

DOPAMINE HYDROCHLORIDE

Application Number

18132

Product Number

4

Dosage Form

-

Strength

80MG/ML

Approval Date

1982-07-09

Regulatory Status

RX

1996
23 May
Discontinued Application: 74403

Drug Name

DOPAMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

40MG/ML

Approval Date

1996-05-23

74403 / 1

Active Ingredient

DOPAMINE HYDROCHLORIDE

Application Number

74403

Product Number

1

Dosage Form

-

Strength

40MG/ML

Approval Date

1996-05-23

Regulatory Status

Discontinued

1995
30 Aug
Discontinued Application: 20542

Drug Name

DOPAMINE HYDROCHLORIDE IN DEXTROSE 5%

Product Number

1

Dosage Form

-

Strength

1.6MG/ML

Approval Date

1995-08-30

20542 / 1

Active Ingredient

DOPAMINE HYDROCHLORIDE

Application Number

20542

Product Number

1

Dosage Form

-

Strength

1.6MG/ML

Approval Date

1995-08-30

Regulatory Status

Discontinued

1983
30 Sep
RX Application: 18826

Drug Name

DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

80MG/100ML

Approval Date

1983-09-30

18826 / 1

Active Ingredient

DOPAMINE HYDROCHLORIDE

Application Number

18826

Product Number

1

Dosage Form

-

Strength

80MG/100ML

Approval Date

1983-09-30

Regulatory Status

RX

1983
30 Sep
RX Application: 18826

Drug Name

DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

160MG/100ML

Approval Date

1983-09-30

18826 / 2

Active Ingredient

DOPAMINE HYDROCHLORIDE

Application Number

18826

Product Number

2

Dosage Form

-

Strength

160MG/100ML

Approval Date

1983-09-30

Regulatory Status

RX

1983
30 Sep
RX Application: 18826

Drug Name

DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

3

Dosage Form

-

Strength

320MG/100ML

Approval Date

1983-09-30

18826 / 3

Active Ingredient

DOPAMINE HYDROCHLORIDE

Application Number

18826

Product Number

3

Dosage Form

-

Strength

320MG/100ML

Approval Date

1983-09-30

Regulatory Status

RX

2018
24 Jul
Discontinued Application: 208614

Drug Name

DOXERCALCIFEROL

Product Number

1

Dosage Form

-

Strength

4MCG/2ML (2MCG/ML)

Approval Date

2018-07-24

208614 / 1

Active Ingredient

DOXERCALCIFEROL

Application Number

208614

Product Number

1

Dosage Form

-

Strength

4MCG/2ML (2MCG/ML)

Approval Date

2018-07-24

Regulatory Status

Discontinued

2018
24 Jul
Discontinued Application: 208614

Drug Name

DOXERCALCIFEROL

Product Number

2

Dosage Form

-

Strength

10MCG/5ML (2MCG/ML)

Approval Date

2018-07-24

208614 / 2

Active Ingredient

DOXERCALCIFEROL

Application Number

208614

Product Number

2

Dosage Form

-

Strength

10MCG/5ML (2MCG/ML)

Approval Date

2018-07-24

Regulatory Status

Discontinued

1988
07 Apr
Discontinued Application: 71645

Drug Name

DROPERIDOL

Product Number

1

Dosage Form

-

Strength

2.5MG/ML

Approval Date

1988-04-07

71645 / 1

Active Ingredient

DROPERIDOL

Application Number

71645

Product Number

1

Dosage Form

-

Strength

2.5MG/ML

Approval Date

1988-04-07

Regulatory Status

Discontinued

1988
29 Feb
Discontinued Application: 71981

Drug Name

DROPERIDOL

Product Number

1

Dosage Form

-

Strength

2.5MG/ML

Approval Date

1988-02-29

71981 / 1

Active Ingredient

DROPERIDOL

Application Number

71981

Product Number

1

Dosage Form

-

Strength

2.5MG/ML

Approval Date

1988-02-29

Regulatory Status

Discontinued

1995
31 Aug
Discontinued Application: 72272

Drug Name

DROPERIDOL

Product Number

1

Dosage Form

-

Strength

2.5MG/ML

Approval Date

1995-08-31

72272 / 1

Active Ingredient

DROPERIDOL

Application Number

72272

Product Number

1

Dosage Form

-

Strength

2.5MG/ML

Approval Date

1995-08-31

Regulatory Status

Discontinued

1998
24 Feb
Discontinued Application: 40131

Drug Name

EDROPHONIUM CHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1998-02-24

40131 / 1

Active Ingredient

EDROPHONIUM CHLORIDE

Application Number

40131

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1998-02-24

Regulatory Status

Discontinued

2000
22 Aug
Discontinued Application: 75456

Drug Name

ENALAPRILAT

Product Number

1

Dosage Form

-

Strength

1.25MG/ML

Approval Date

2000-08-22

75456 / 1

Active Ingredient

ENALAPRILAT

Application Number

75456

Product Number

1

Dosage Form

-

Strength

1.25MG/ML

Approval Date

2000-08-22

Regulatory Status

Discontinued

2000
22 Aug
Discontinued Application: 75458

Drug Name

ENALAPRILAT

Product Number

1

Dosage Form

-

Strength

1.25MG/ML

Approval Date

2000-08-22

75458 / 1

Active Ingredient

ENALAPRILAT

Application Number

75458

Product Number

1

Dosage Form

-

Strength

1.25MG/ML

Approval Date

2000-08-22

Regulatory Status

Discontinued

2000
22 Aug
Discontinued Application: 75571

Drug Name

ENALAPRILAT

Product Number

1

Dosage Form

-

Strength

1.25MG/ML

Approval Date

2000-08-22

75571 / 1

Active Ingredient

ENALAPRILAT

Application Number

75571

Product Number

1

Dosage Form

-

Strength

1.25MG/ML

Approval Date

2000-08-22

Regulatory Status

Discontinued

-
Unclassified Application: 208908

Drug Name

EPINEPHRINE

Product Number

1

Dosage Form

-

Strength

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

Approval Date

-

208908 / 1

Active Ingredient

EPINEPHRINE

Application Number

208908

Product Number

1

Dosage Form

-

Strength

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

Approval Date

-

Regulatory Status

Unclassified

2019
05 Nov
Discontinued Application: 209359

Drug Name

EPINEPHRINE

Product Number

1

Dosage Form

-

Strength

1MG/10ML (0.1MG/ML)

Approval Date

2019-11-05

209359 / 1

Active Ingredient

EPINEPHRINE

Application Number

209359

Product Number

1

Dosage Form

-

Strength

1MG/10ML (0.1MG/ML)

Approval Date

2019-11-05

Regulatory Status

Discontinued

2006
15 Sep
Discontinued Application: 50807

Drug Name

EPIRUBICIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG/VIAL

Approval Date

2006-09-15

50807 / 1

Active Ingredient

EPIRUBICIN HYDROCHLORIDE

Application Number

50807

Product Number

1

Dosage Form

-

Strength

50MG/VIAL

Approval Date

2006-09-15

Regulatory Status

Discontinued

2006
15 Sep
Discontinued Application: 50807

Drug Name

EPIRUBICIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

200MG/VIAL

Approval Date

2006-09-15

50807 / 2

Active Ingredient

EPIRUBICIN HYDROCHLORIDE

Application Number

50807

Product Number

2

Dosage Form

-

Strength

200MG/VIAL

Approval Date

2006-09-15

Regulatory Status

Discontinued

2007
19 Apr
Discontinued Application: 65343

Drug Name

EPIRUBICIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG/5ML (2MG/ML)

Approval Date

2007-04-19

65343 / 1

Active Ingredient

EPIRUBICIN HYDROCHLORIDE

Application Number

65343

Product Number

1

Dosage Form

-

Strength

10MG/5ML (2MG/ML)

Approval Date

2007-04-19

Regulatory Status

Discontinued

2007
19 Apr
Discontinued Application: 65343

Drug Name

EPIRUBICIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

50MG/25ML (2MG/ML)

Approval Date

2007-04-19

65343 / 2

Active Ingredient

EPIRUBICIN HYDROCHLORIDE

Application Number

65343

Product Number

2

Dosage Form

-

Strength

50MG/25ML (2MG/ML)

Approval Date

2007-04-19

Regulatory Status

Discontinued

2007
19 Apr
Discontinued Application: 65343

Drug Name

EPIRUBICIN HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

150MG/75ML (2MG/ML)

Approval Date

2007-04-19

65343 / 3

Active Ingredient

EPIRUBICIN HYDROCHLORIDE

Application Number

65343

Product Number

3

Dosage Form

-

Strength

150MG/75ML (2MG/ML)

Approval Date

2007-04-19

Regulatory Status

Discontinued

2007
19 Apr
Discontinued Application: 65343

Drug Name

EPIRUBICIN HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

200MG/100ML (2MG/ML)

Approval Date

2007-04-19

65343 / 4

Active Ingredient

EPIRUBICIN HYDROCHLORIDE

Application Number

65343

Product Number

4

Dosage Form

-

Strength

200MG/100ML (2MG/ML)

Approval Date

2007-04-19

Regulatory Status

Discontinued

1985
22 Jul
Discontinued Application: 50593

Drug Name

ERYC SPRINKLES

Product Number

1

Dosage Form

-

Strength

125MG

Approval Date

1985-07-22

50593 / 1

Active Ingredient

ERYTHROMYCIN

Application Number

50593

Product Number

1

Dosage Form

-

Strength

125MG

Approval Date

1985-07-22

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 50182

Drug Name

ERYTHROCIN

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1982-01-01

50182 / 2

Active Ingredient

ERYTHROMYCIN LACTOBIONATE

Application Number

50182

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 50182

Drug Name

ERYTHROCIN

Product Number

3

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1982-01-01

50182 / 3

Active Ingredient

ERYTHROMYCIN LACTOBIONATE

Application Number

50182

Product Number

3

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1982-01-01

Regulatory Status

Discontinued

1986
24 Sep
RX Application: 50609

Drug Name

ERYTHROCIN

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1986-09-24

50609 / 1

Active Ingredient

ERYTHROMYCIN LACTOBIONATE

Application Number

50609

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1986-09-24

Regulatory Status

RX

1986
24 Sep
Discontinued Application: 50609

Drug Name

ERYTHROCIN

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1986-09-24

50609 / 2

Active Ingredient

ERYTHROMYCIN LACTOBIONATE

Application Number

50609

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1986-09-24

Regulatory Status

Discontinued

1986
31 Oct
RX Application: 62638

Drug Name

ERYTHROCIN

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1986-10-31

62638 / 1

Active Ingredient

ERYTHROMYCIN LACTOBIONATE

Application Number

62638

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1986-10-31

Regulatory Status

RX

1986
31 Oct
Discontinued Application: 62638

Drug Name

ERYTHROCIN

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1986-10-31

62638 / 2

Active Ingredient

ERYTHROMYCIN LACTOBIONATE

Application Number

62638

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1986-10-31

Regulatory Status

Discontinued

1995
30 Aug
Discontinued Application: 74320

Drug Name

ETOPOSIDE

Product Number

1

Dosage Form

-

Strength

20MG/ML

Approval Date

1995-08-30

74320 / 1

Active Ingredient

ETOPOSIDE

Application Number

74320

Product Number

1

Dosage Form

-

Strength

20MG/ML

Approval Date

1995-08-30

Regulatory Status

Discontinued

1995
30 Aug
Discontinued Application: 74351

Drug Name

ETOPOSIDE

Product Number

1

Dosage Form

-

Strength

20MG/ML

Approval Date

1995-08-30

74351 / 1

Active Ingredient

ETOPOSIDE

Application Number

74351

Product Number

1

Dosage Form

-

Strength

20MG/ML

Approval Date

1995-08-30

Regulatory Status

Discontinued

2001
16 Apr
Discontinued Application: 75705

Drug Name

FAMOTIDINE

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2001-04-16

75705 / 1

Active Ingredient

FAMOTIDINE

Application Number

75705

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2001-04-16

Regulatory Status

Discontinued

2001
23 Nov
Discontinued Application: 75870

Drug Name

FAMOTIDINE

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2001-11-23

75870 / 1

Active Ingredient

FAMOTIDINE

Application Number

75870

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2001-11-23

Regulatory Status

Discontinued

2001
23 Nov
Discontinued Application: 75905

Drug Name

FAMOTIDINE

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2001-11-23

75905 / 1

Active Ingredient

FAMOTIDINE

Application Number

75905

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2001-11-23

Regulatory Status

Discontinued

2001
16 Apr
Discontinued Application: 75669

Drug Name

FAMOTIDINE PRESERVATIVE FREE

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2001-04-16

75669 / 1

Active Ingredient

FAMOTIDINE

Application Number

75669

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2001-04-16

Regulatory Status

Discontinued

1985
12 Jan
RX Application: 19115

Drug Name

FENTANYL CITRATE

Product Number

1

Dosage Form

-

Strength

EQ 0.05MG BASE/ML

Approval Date

1985-01-12

19115 / 1

Active Ingredient

FENTANYL CITRATE

Application Number

19115

Product Number

1

Dosage Form

-

Strength

EQ 0.05MG BASE/ML

Approval Date

1985-01-12

Regulatory Status

RX

1988
04 May
Discontinued Application: 71982

Drug Name

FENTANYL CITRATE AND DROPERIDOL

Product Number

1

Dosage Form

-

Strength

2.5MG/ML;EQ 0.05MG BASE/ML

Approval Date

1988-05-04

71982 / 1

Active Ingredient

DROPERIDOL; FENTANYL CITRATE

Application Number

71982

Product Number

1

Dosage Form

-

Strength

2.5MG/ML;EQ 0.05MG BASE/ML

Approval Date

1988-05-04

Regulatory Status

Discontinued

1991
24 Sep
Discontinued Application: 72786

Drug Name

FENTANYL CITRATE PRESERVATIVE FREE

Product Number

1

Dosage Form

-

Strength

EQ 0.05MG BASE/ML

Approval Date

1991-09-24

72786 / 1

Active Ingredient

FENTANYL CITRATE

Application Number

72786

Product Number

1

Dosage Form

-

Strength

EQ 0.05MG BASE/ML

Approval Date

1991-09-24

Regulatory Status

Discontinued

2004
29 Jul
Discontinued Application: 76304

Drug Name

FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

200MG/100ML (2MG/ML)

Approval Date

2004-07-29

76304 / 1

Active Ingredient

FLUCONAZOLE

Application Number

76304

Product Number

1

Dosage Form

-

Strength

200MG/100ML (2MG/ML)

Approval Date

2004-07-29

Regulatory Status

Discontinued

2004
29 Jul
Discontinued Application: 76304

Drug Name

FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

400MG/200ML (2MG/ML)

Approval Date

2004-07-29

76304 / 2

Active Ingredient

FLUCONAZOLE

Application Number

76304

Product Number

2

Dosage Form

-

Strength

400MG/200ML (2MG/ML)

Approval Date

2004-07-29

Regulatory Status

Discontinued

2004
29 Jul
RX Application: 76303

Drug Name

FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

200MG/100ML (2MG/ML)

Approval Date

2004-07-29

76303 / 1

Active Ingredient

FLUCONAZOLE

Application Number

76303

Product Number

1

Dosage Form

-

Strength

200MG/100ML (2MG/ML)

Approval Date

2004-07-29

Regulatory Status

RX

2004
29 Jul
RX Application: 76303

Drug Name

FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

400MG/200ML (2MG/ML)

Approval Date

2004-07-29

76303 / 2

Active Ingredient

FLUCONAZOLE

Application Number

76303

Product Number

2

Dosage Form

-

Strength

400MG/200ML (2MG/ML)

Approval Date

2004-07-29

Regulatory Status

RX

2004
29 Jul
Discontinued Application: 76617

Drug Name

FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

200MG/100ML (2MG/ML)

Approval Date

2004-07-29

76617 / 1

Active Ingredient

FLUCONAZOLE

Application Number

76617

Product Number

1

Dosage Form

-

Strength

200MG/100ML (2MG/ML)

Approval Date

2004-07-29

Regulatory Status

Discontinued

2004
29 Jul
Discontinued Application: 76617

Drug Name

FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

400MG/200ML (2MG/ML)

Approval Date

2004-07-29

76617 / 2

Active Ingredient

FLUCONAZOLE

Application Number

76617

Product Number

2

Dosage Form

-

Strength

400MG/200ML (2MG/ML)

Approval Date

2004-07-29

Regulatory Status

Discontinued

2007
06 Apr
Discontinued Application: 77790

Drug Name

FLUDARABINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

50MG/VIAL

Approval Date

2007-04-06

77790 / 1

Active Ingredient

FLUDARABINE PHOSPHATE

Application Number

77790

Product Number

1

Dosage Form

-

Strength

50MG/VIAL

Approval Date

2007-04-06

Regulatory Status

Discontinued

1998
16 Apr
Discontinued Application: 74966

Drug Name

FLUPHENAZINE DECANOATE

Product Number

1

Dosage Form

-

Strength

25MG/ML

Approval Date

1998-04-16

74966 / 1

Active Ingredient

FLUPHENAZINE DECANOATE

Application Number

74966

Product Number

1

Dosage Form

-

Strength

25MG/ML

Approval Date

1998-04-16

Regulatory Status

Discontinued

2005
31 May
Discontinued Application: 77174

Drug Name

FOSCARNET SODIUM

Product Number

1

Dosage Form

-

Strength

6GM/250ML (24MG/ML)

Approval Date

2005-05-31

77174 / 1

Active Ingredient

FOSCARNET SODIUM

Application Number

77174

Product Number

1

Dosage Form

-

Strength

6GM/250ML (24MG/ML)

Approval Date

2005-05-31

Regulatory Status

Discontinued

2005
31 May
Discontinued Application: 77174

Drug Name

FOSCARNET SODIUM

Product Number

2

Dosage Form

-

Strength

12GM/500ML (24MG/ML)

Approval Date

2005-05-31

77174 / 2

Active Ingredient

FOSCARNET SODIUM

Application Number

77174

Product Number

2

Dosage Form

-

Strength

12GM/500ML (24MG/ML)

Approval Date

2005-05-31

Regulatory Status

Discontinued

2007
06 Aug
Discontinued Application: 78158

Drug Name

FOSPHENYTOIN SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 50MG PHENYTOIN NA/ML

Approval Date

2007-08-06

78158 / 1

Active Ingredient

FOSPHENYTOIN SODIUM

Application Number

78158

Product Number

1

Dosage Form

-

Strength

EQ 50MG PHENYTOIN NA/ML

Approval Date

2007-08-06

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 16929

Drug Name

FUDR

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

16929 / 1

Active Ingredient

FLOXURIDINE

Application Number

16929

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
28 May
RX Application: 18667

Drug Name

FUROSEMIDE

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1982-05-28

18667 / 1

Active Ingredient

FUROSEMIDE

Application Number

18667

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1982-05-28

Regulatory Status

RX

1987
08 Jul
Discontinued Application: 70578

Drug Name

FUROSEMIDE

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1987-07-08

70578 / 1

Active Ingredient

FUROSEMIDE

Application Number

70578

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1987-07-08

Regulatory Status

Discontinued

1991
13 Aug
Discontinued Application: 72080

Drug Name

FUROSEMIDE

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1991-08-13

72080 / 1

Active Ingredient

FUROSEMIDE

Application Number

72080

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1991-08-13

Regulatory Status

Discontinued

1994
31 Oct
Discontinued Application: 74337

Drug Name

FUROSEMIDE

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1994-10-31

74337 / 1

Active Ingredient

FUROSEMIDE

Application Number

74337

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1994-10-31

Regulatory Status

Discontinued

1999
28 May
RX Application: 75241

Drug Name

FUROSEMIDE

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1999-05-28

75241 / 1

Active Ingredient

FUROSEMIDE

Application Number

75241

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1999-05-28

Regulatory Status

RX

2011
25 Jul
RX Application: 78339

Drug Name

GEMCITABINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE/VIAL

Approval Date

2011-07-25

78339 / 1

Active Ingredient

GEMCITABINE HYDROCHLORIDE

Application Number

78339

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE/VIAL

Approval Date

2011-07-25

Regulatory Status

RX

2011
25 Jul
RX Application: 78339

Drug Name

GEMCITABINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2011-07-25

78339 / 2

Active Ingredient

GEMCITABINE HYDROCHLORIDE

Application Number

78339

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2011-07-25

Regulatory Status

RX

2010
15 Nov
RX Application: 79183

Drug Name

GEMCITABINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

2010-11-15

79183 / 1

Active Ingredient

GEMCITABINE HYDROCHLORIDE

Application Number

79183

Product Number

1

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

2010-11-15

Regulatory Status

RX

2011
04 Aug
RX Application: 200795

Drug Name

GEMCITABINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

200MG/5.26ML (38MG/ML)

Approval Date

2011-08-04

200795 / 1

Active Ingredient

GEMCITABINE HYDROCHLORIDE

Application Number

200795

Product Number

1

Dosage Form

-

Strength

200MG/5.26ML (38MG/ML)

Approval Date

2011-08-04

Regulatory Status

RX

2011
04 Aug
RX Application: 200795

Drug Name

GEMCITABINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

1GM/26.3ML (38MG/ML)

Approval Date

2011-08-04

200795 / 2

Active Ingredient

GEMCITABINE HYDROCHLORIDE

Application Number

200795

Product Number

2

Dosage Form

-

Strength

1GM/26.3ML (38MG/ML)

Approval Date

2011-08-04

Regulatory Status

RX

2011
04 Aug
RX Application: 200795

Drug Name

GEMCITABINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

2GM/52.6ML (38MG/ML)

Approval Date

2011-08-04

200795 / 3

Active Ingredient

GEMCITABINE HYDROCHLORIDE

Application Number

200795

Product Number

3

Dosage Form

-

Strength

2GM/52.6ML (38MG/ML)

Approval Date

2011-08-04

Regulatory Status

RX

1983
15 Aug
RX Application: 62420

Drug Name

GENTAMICIN SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

1983-08-15

62420 / 1

Active Ingredient

GENTAMICIN SULFATE

Application Number

62420

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

1983-08-15

Regulatory Status

RX

1983
15 Aug
RX Application: 62420

Drug Name

GENTAMICIN SULFATE

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE/ML

Approval Date

1983-08-15

62420 / 2

Active Ingredient

GENTAMICIN SULFATE

Application Number

62420

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE/ML

Approval Date

1983-08-15

Regulatory Status

RX

1986
20 Feb
Discontinued Application: 62612

Drug Name

GENTAMICIN SULFATE

Product Number

4

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

1986-02-20

62612 / 4

Active Ingredient

GENTAMICIN SULFATE

Application Number

62612

Product Number

4

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

1986-02-20

Regulatory Status

Discontinued

1983
15 Aug
Discontinued Application: 62414

Drug Name

GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

EQ 1.2MG BASE/ML

Approval Date

1983-08-15

62414 / 1

Active Ingredient

GENTAMICIN SULFATE

Application Number

62414

Product Number

1

Dosage Form

-

Strength

EQ 1.2MG BASE/ML

Approval Date

1983-08-15

Regulatory Status

Discontinued

1983
15 Aug
Discontinued Application: 62414

Drug Name

GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

EQ 1.4MG BASE/ML

Approval Date

1983-08-15

62414 / 2

Active Ingredient

GENTAMICIN SULFATE

Application Number

62414

Product Number

2

Dosage Form

-

Strength

EQ 1.4MG BASE/ML

Approval Date

1983-08-15

Regulatory Status

Discontinued

1983
15 Aug
Discontinued Application: 62414

Drug Name

GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

3

Dosage Form

-

Strength

EQ 1.6MG BASE/ML

Approval Date

1983-08-15

62414 / 3

Active Ingredient

GENTAMICIN SULFATE

Application Number

62414

Product Number

3

Dosage Form

-

Strength

EQ 1.6MG BASE/ML

Approval Date

1983-08-15

Regulatory Status

Discontinued

1983
15 Aug
Discontinued Application: 62414

Drug Name

GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

4

Dosage Form

-

Strength

EQ 1.8MG BASE/ML

Approval Date

1983-08-15

62414 / 4

Active Ingredient

GENTAMICIN SULFATE

Application Number

62414

Product Number

4

Dosage Form

-

Strength

EQ 1.8MG BASE/ML

Approval Date

1983-08-15

Regulatory Status

Discontinued

1983
15 Aug
Discontinued Application: 62414

Drug Name

GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

5

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

1983-08-15

62414 / 5

Active Ingredient

GENTAMICIN SULFATE

Application Number

62414

Product Number

5

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

1983-08-15

Regulatory Status

Discontinued

1983
15 Aug
Discontinued Application: 62414

Drug Name

GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

6

Dosage Form

-

Strength

EQ 60MG BASE/100ML

Approval Date

1983-08-15

62414 / 6

Active Ingredient

GENTAMICIN SULFATE

Application Number

62414

Product Number

6

Dosage Form

-

Strength

EQ 60MG BASE/100ML

Approval Date

1983-08-15

Regulatory Status

Discontinued

1983
15 Aug
Discontinued Application: 62414

Drug Name

GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

7

Dosage Form

-

Strength

EQ 70MG BASE/100ML

Approval Date

1983-08-15

62414 / 7

Active Ingredient

GENTAMICIN SULFATE

Application Number

62414

Product Number

7

Dosage Form

-

Strength

EQ 70MG BASE/100ML

Approval Date

1983-08-15

Regulatory Status

Discontinued

1983
15 Aug
Discontinued Application: 62414

Drug Name

GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

8

Dosage Form

-

Strength

EQ 80MG BASE/100ML

Approval Date

1983-08-15

62414 / 8

Active Ingredient

GENTAMICIN SULFATE

Application Number

62414

Product Number

8

Dosage Form

-

Strength

EQ 80MG BASE/100ML

Approval Date

1983-08-15

Regulatory Status

Discontinued

1983
15 Aug
Discontinued Application: 62414

Drug Name

GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

9

Dosage Form

-

Strength

EQ 90MG BASE/100ML

Approval Date

1983-08-15

62414 / 9

Active Ingredient

GENTAMICIN SULFATE

Application Number

62414

Product Number

9

Dosage Form

-

Strength

EQ 90MG BASE/100ML

Approval Date

1983-08-15

Regulatory Status

Discontinued

1983
15 Aug
Discontinued Application: 62414

Drug Name

GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

10

Dosage Form

-

Strength

EQ 100MG BASE/100ML

Approval Date

1983-08-15

62414 / 10

Active Ingredient

GENTAMICIN SULFATE

Application Number

62414

Product Number

10

Dosage Form

-

Strength

EQ 100MG BASE/100ML

Approval Date

1983-08-15

Regulatory Status

Discontinued

1986
06 Jan
Discontinued Application: 62588

Drug Name

GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

EQ 1.2MG BASE/ML

Approval Date

1986-01-06

62588 / 1

Active Ingredient

GENTAMICIN SULFATE

Application Number

62588

Product Number

1

Dosage Form

-

Strength

EQ 1.2MG BASE/ML

Approval Date

1986-01-06

Regulatory Status

Discontinued

1986
06 Jan
Discontinued Application: 62588

Drug Name

GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

EQ 1.4MG BASE/ML

Approval Date

1986-01-06

62588 / 2

Active Ingredient

GENTAMICIN SULFATE

Application Number

62588

Product Number

2

Dosage Form

-

Strength

EQ 1.4MG BASE/ML

Approval Date

1986-01-06

Regulatory Status

Discontinued

1986
06 Jan
Discontinued Application: 62588

Drug Name

GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

3

Dosage Form

-

Strength

EQ 1.6MG BASE/ML

Approval Date

1986-01-06

62588 / 3

Active Ingredient

GENTAMICIN SULFATE

Application Number

62588

Product Number

3

Dosage Form

-

Strength

EQ 1.6MG BASE/ML

Approval Date

1986-01-06

Regulatory Status

Discontinued

1986
06 Jan
Discontinued Application: 62588

Drug Name

GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

4

Dosage Form

-

Strength

EQ 1.8MG BASE/ML

Approval Date

1986-01-06

62588 / 4

Active Ingredient

GENTAMICIN SULFATE

Application Number

62588

Product Number

4

Dosage Form

-

Strength

EQ 1.8MG BASE/ML

Approval Date

1986-01-06

Regulatory Status

Discontinued

1986
06 Jan
Discontinued Application: 62588

Drug Name

GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

5

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

1986-01-06

62588 / 5

Active Ingredient

GENTAMICIN SULFATE

Application Number

62588

Product Number

5

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

1986-01-06

Regulatory Status

Discontinued

1986
06 Jan
Discontinued Application: 62588

Drug Name

GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

6

Dosage Form

-

Strength

EQ 60MG BASE/100ML

Approval Date

1986-01-06

62588 / 6

Active Ingredient

GENTAMICIN SULFATE

Application Number

62588

Product Number

6

Dosage Form

-

Strength

EQ 60MG BASE/100ML

Approval Date

1986-01-06

Regulatory Status

Discontinued

1986
06 Jan
Discontinued Application: 62588

Drug Name

GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

7

Dosage Form

-

Strength

EQ 70MG BASE/100ML

Approval Date

1986-01-06

62588 / 7

Active Ingredient

GENTAMICIN SULFATE

Application Number

62588

Product Number

7

Dosage Form

-

Strength

EQ 70MG BASE/100ML

Approval Date

1986-01-06

Regulatory Status

Discontinued

1986
06 Jan
Discontinued Application: 62588

Drug Name

GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

8

Dosage Form

-

Strength

EQ 80MG BASE/100ML

Approval Date

1986-01-06

62588 / 8

Active Ingredient

GENTAMICIN SULFATE

Application Number

62588

Product Number

8

Dosage Form

-

Strength

EQ 80MG BASE/100ML

Approval Date

1986-01-06

Regulatory Status

Discontinued

1986
06 Jan
Discontinued Application: 62588

Drug Name

GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

9

Dosage Form

-

Strength

EQ 90MG BASE/100ML

Approval Date

1986-01-06

62588 / 9

Active Ingredient

GENTAMICIN SULFATE

Application Number

62588

Product Number

9

Dosage Form

-

Strength

EQ 90MG BASE/100ML

Approval Date

1986-01-06

Regulatory Status

Discontinued

1986
06 Jan
Discontinued Application: 62588

Drug Name

GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

10

Dosage Form

-

Strength

EQ 100MG BASE/100ML

Approval Date

1986-01-06

62588 / 10

Active Ingredient

GENTAMICIN SULFATE

Application Number

62588

Product Number

10

Dosage Form

-

Strength

EQ 100MG BASE/100ML

Approval Date

1986-01-06

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17633

Drug Name

GLYCINE 1.5% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

1.5GM/100ML

Approval Date

1982-01-01

17633 / 1

Active Ingredient

GLYCINE

Application Number

17633

Product Number

1

Dosage Form

-

Strength

1.5GM/100ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1988
15 Jun
Discontinued Application: 89393

Drug Name

GLYCOPYRROLATE

Product Number

1

Dosage Form

-

Strength

0.2MG/ML

Approval Date

1988-06-15

89393 / 1

Active Ingredient

GLYCOPYRROLATE

Application Number

89393

Product Number

1

Dosage Form

-

Strength

0.2MG/ML

Approval Date

1988-06-15

Regulatory Status

Discontinued

2000
09 Feb
Discontinued Application: 75176

Drug Name

HALOPERIDOL DECANOATE

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/ML

Approval Date

2000-02-09

75176 / 1

Active Ingredient

HALOPERIDOL DECANOATE

Application Number

75176

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/ML

Approval Date

2000-02-09

Regulatory Status

Discontinued

2000
09 Feb
Discontinued Application: 75176

Drug Name

HALOPERIDOL DECANOATE

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE/ML

Approval Date

2000-02-09

75176 / 2

Active Ingredient

HALOPERIDOL DECANOATE

Application Number

75176

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE/ML

Approval Date

2000-02-09

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83254

Drug Name

HALOTHANE

Product Number

1

Dosage Form

-

Strength

99.99%

Approval Date

1982-01-01

83254 / 1

Active Ingredient

HALOTHANE

Application Number

83254

Product Number

1

Dosage Form

-

Strength

99.99%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 5264

Drug Name

HEPARIN LOCK FLUSH

Product Number

10

Dosage Form

-

Strength

100 UNITS/ML

Approval Date

1982-01-01

5264 / 10

Active Ingredient

HEPARIN SODIUM

Application Number

5264

Product Number

10

Dosage Form

-

Strength

100 UNITS/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1996
26 Jul
Discontinued Application: 40095

Drug Name

HEPARIN SODIUM

Product Number

1

Dosage Form

-

Strength

10,000 UNITS/ML

Approval Date

1996-07-26

40095 / 1

Active Ingredient

HEPARIN SODIUM

Application Number

40095

Product Number

1

Dosage Form

-

Strength

10,000 UNITS/ML

Approval Date

1996-07-26

Regulatory Status

Discontinued

1983
28 Apr
Discontinued Application: 88099

Drug Name

HEPARIN SODIUM

Product Number

1

Dosage Form

-

Strength

2,500 UNITS/ML

Approval Date

1983-04-28

88099 / 1

Active Ingredient

HEPARIN SODIUM

Application Number

88099

Product Number

1

Dosage Form

-

Strength

2,500 UNITS/ML

Approval Date

1983-04-28

Regulatory Status

Discontinued

1983
28 Apr
RX Application: 88100

Drug Name

HEPARIN SODIUM

Product Number

1

Dosage Form

-

Strength

5,000 UNITS/ML

Approval Date

1983-04-28

88100 / 1

Active Ingredient

HEPARIN SODIUM

Application Number

88100

Product Number

1

Dosage Form

-

Strength

5,000 UNITS/ML

Approval Date

1983-04-28

Regulatory Status

RX

2009
31 Aug
RX Application: 90571

Drug Name

HEPARIN SODIUM

Product Number

1

Dosage Form

-

Strength

1,000 UNITS/ML

Approval Date

2009-08-31

90571 / 1

Active Ingredient

HEPARIN SODIUM

Application Number

90571

Product Number

1

Dosage Form

-

Strength

1,000 UNITS/ML

Approval Date

2009-08-31

Regulatory Status

RX

2009
31 Aug
RX Application: 90571

Drug Name

HEPARIN SODIUM

Product Number

2

Dosage Form

-

Strength

5,000 UNITS/ML

Approval Date

2009-08-31

90571 / 2

Active Ingredient

HEPARIN SODIUM

Application Number

90571

Product Number

2

Dosage Form

-

Strength

5,000 UNITS/ML

Approval Date

2009-08-31

Regulatory Status

RX

2009
31 Aug
RX Application: 90571

Drug Name

HEPARIN SODIUM

Product Number

3

Dosage Form

-

Strength

10,000 UNITS/ML

Approval Date

2009-08-31

90571 / 3

Active Ingredient

HEPARIN SODIUM

Application Number

90571

Product Number

3

Dosage Form

-

Strength

10,000 UNITS/ML

Approval Date

2009-08-31

Regulatory Status

RX

1989
23 Jun
RX Application: 18916

Drug Name

HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

10

Dosage Form

-

Strength

200 UNITS/100ML

Approval Date

1989-06-23

18916 / 10

Active Ingredient

HEPARIN SODIUM

Application Number

18916

Product Number

10

Dosage Form

-

Strength

200 UNITS/100ML

Approval Date

1989-06-23

Regulatory Status

RX

1985
30 Jan
Discontinued Application: 18911

Drug Name

HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5%

Product Number

6

Dosage Form

-

Strength

10,000 UNITS/100ML

Approval Date

1985-01-30

18911 / 6

Active Ingredient

HEPARIN SODIUM

Application Number

18911

Product Number

6

Dosage Form

-

Strength

10,000 UNITS/100ML

Approval Date

1985-01-30

Regulatory Status

Discontinued

1985
27 Mar
RX Application: 19339

Drug Name

HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

3

Dosage Form

-

Strength

10,000 UNITS/100ML

Approval Date

1985-03-27

19339 / 3

Active Ingredient

HEPARIN SODIUM

Application Number

19339

Product Number

3

Dosage Form

-

Strength

10,000 UNITS/100ML

Approval Date

1985-03-27

Regulatory Status

RX

1985
30 Jan
Discontinued Application: 18911

Drug Name

HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.45%

Product Number

1

Dosage Form

-

Strength

10,000 UNITS/100ML

Approval Date

1985-01-30

18911 / 1

Active Ingredient

HEPARIN SODIUM

Application Number

18911

Product Number

1

Dosage Form

-

Strength

10,000 UNITS/100ML

Approval Date

1985-01-30

Regulatory Status

Discontinued

1984
31 Jan
Discontinued Application: 18916

Drug Name

HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.45%

Product Number

5

Dosage Form

-

Strength

10,000 UNITS/100ML

Approval Date

1984-01-31

18916 / 5

Active Ingredient

HEPARIN SODIUM

Application Number

18916

Product Number

5

Dosage Form

-

Strength

10,000 UNITS/100ML

Approval Date

1984-01-31

Regulatory Status

Discontinued

1985
30 Jan
Discontinued Application: 18911

Drug Name

HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.9%

Product Number

3

Dosage Form

-

Strength

10,000 UNITS/100ML

Approval Date

1985-01-30

18911 / 3

Active Ingredient

HEPARIN SODIUM

Application Number

18911

Product Number

3

Dosage Form

-

Strength

10,000 UNITS/100ML

Approval Date

1985-01-30

Regulatory Status

Discontinued

1984
31 Jan
Discontinued Application: 18916

Drug Name

HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.9%

Product Number

2

Dosage Form

-

Strength

10,000 UNITS/100ML

Approval Date

1984-01-31

18916 / 2

Active Ingredient

HEPARIN SODIUM

Application Number

18916

Product Number

2

Dosage Form

-

Strength

10,000 UNITS/100ML

Approval Date

1984-01-31

Regulatory Status

Discontinued

1985
30 Jan
Discontinued Application: 18911

Drug Name

HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5%

Product Number

7

Dosage Form

-

Strength

5,000 UNITS/100ML

Approval Date

1985-01-30

18911 / 7

Active Ingredient

HEPARIN SODIUM

Application Number

18911

Product Number

7

Dosage Form

-

Strength

5,000 UNITS/100ML

Approval Date

1985-01-30

Regulatory Status

Discontinued

1985
27 Mar
RX Application: 19339

Drug Name

HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

5,000 UNITS/100ML

Approval Date

1985-03-27

19339 / 1

Active Ingredient

HEPARIN SODIUM

Application Number

19339

Product Number

1

Dosage Form

-

Strength

5,000 UNITS/100ML

Approval Date

1985-03-27

Regulatory Status

RX

1984
31 Jan
RX Application: 18916

Drug Name

HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

Product Number

6

Dosage Form

-

Strength

5,000 UNITS/100ML

Approval Date

1984-01-31

18916 / 6

Active Ingredient

HEPARIN SODIUM

Application Number

18916

Product Number

6

Dosage Form

-

Strength

5,000 UNITS/100ML

Approval Date

1984-01-31

Regulatory Status

RX

1985
30 Jan
Discontinued Application: 18911

Drug Name

HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.9%

Product Number

5

Dosage Form

-

Strength

5,000 UNITS/100ML

Approval Date

1985-01-30

18911 / 5

Active Ingredient

HEPARIN SODIUM

Application Number

18911

Product Number

5

Dosage Form

-

Strength

5,000 UNITS/100ML

Approval Date

1985-01-30

Regulatory Status

Discontinued

1984
31 Jan
Discontinued Application: 18916

Drug Name

HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.9%

Product Number

3

Dosage Form

-

Strength

5,000 UNITS/100ML

Approval Date

1984-01-31

18916 / 3

Active Ingredient

HEPARIN SODIUM

Application Number

18916

Product Number

3

Dosage Form

-

Strength

5,000 UNITS/100ML

Approval Date

1984-01-31

Regulatory Status

Discontinued

1989
23 Jun
RX Application: 18916

Drug Name

HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

11

Dosage Form

-

Strength

200 UNITS/100ML

Approval Date

1989-06-23

18916 / 11

Active Ingredient

HEPARIN SODIUM

Application Number

18916

Product Number

11

Dosage Form

-

Strength

200 UNITS/100ML

Approval Date

1989-06-23

Regulatory Status

RX

1989
25 Jan
Discontinued Application: 19805

Drug Name

HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

4,000 UNITS/100ML

Approval Date

1989-01-25

19805 / 1

Active Ingredient

HEPARIN SODIUM

Application Number

19805

Product Number

1

Dosage Form

-

Strength

4,000 UNITS/100ML

Approval Date

1989-01-25

Regulatory Status

Discontinued

1985
30 Jan
Discontinued Application: 18911

Drug Name

HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5%

Product Number

8

Dosage Form

-

Strength

10,000 UNITS/100ML

Approval Date

1985-01-30

18911 / 8

Active Ingredient

HEPARIN SODIUM

Application Number

18911

Product Number

8

Dosage Form

-

Strength

10,000 UNITS/100ML

Approval Date

1985-01-30

Regulatory Status

Discontinued

1985
30 Jan
Discontinued Application: 18911

Drug Name

HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5%

Product Number

9

Dosage Form

-

Strength

5,000 UNITS/100ML

Approval Date

1985-01-30

18911 / 9

Active Ingredient

HEPARIN SODIUM

Application Number

18911

Product Number

9

Dosage Form

-

Strength

5,000 UNITS/100ML

Approval Date

1985-01-30

Regulatory Status

Discontinued

1985
27 Mar
RX Application: 19339

Drug Name

HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

10,000 UNITS/100ML

Approval Date

1985-03-27

19339 / 2

Active Ingredient

HEPARIN SODIUM

Application Number

19339

Product Number

2

Dosage Form

-

Strength

10,000 UNITS/100ML

Approval Date

1985-03-27

Regulatory Status

RX

1985
27 Mar
RX Application: 19339

Drug Name

HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

4

Dosage Form

-

Strength

5,000 UNITS/100ML

Approval Date

1985-03-27

19339 / 4

Active Ingredient

HEPARIN SODIUM

Application Number

19339

Product Number

4

Dosage Form

-

Strength

5,000 UNITS/100ML

Approval Date

1985-03-27

Regulatory Status

RX

1989
25 Jan
Discontinued Application: 19805

Drug Name

HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

5,000 UNITS/100ML

Approval Date

1989-01-25

19805 / 2

Active Ingredient

HEPARIN SODIUM

Application Number

19805

Product Number

2

Dosage Form

-

Strength

5,000 UNITS/100ML

Approval Date

1989-01-25

Regulatory Status

Discontinued

1984
31 Jan
RX Application: 18916

Drug Name

HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

Product Number

7

Dosage Form

-

Strength

5,000 UNITS/100ML

Approval Date

1984-01-31

18916 / 7

Active Ingredient

HEPARIN SODIUM

Application Number

18916

Product Number

7

Dosage Form

-

Strength

5,000 UNITS/100ML

Approval Date

1984-01-31

Regulatory Status

RX

1984
31 Jan
RX Application: 18916

Drug Name

HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

Product Number

8

Dosage Form

-

Strength

10,000 UNITS/100ML

Approval Date

1984-01-31

18916 / 8

Active Ingredient

HEPARIN SODIUM

Application Number

18916

Product Number

8

Dosage Form

-

Strength

10,000 UNITS/100ML

Approval Date

1984-01-31

Regulatory Status

RX

1985
30 Jan
Discontinued Application: 18911

Drug Name

HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9%

Product Number

4

Dosage Form

-

Strength

5,000 UNITS/100ML

Approval Date

1985-01-30

18911 / 4

Active Ingredient

HEPARIN SODIUM

Application Number

18911

Product Number

4

Dosage Form

-

Strength

5,000 UNITS/100ML

Approval Date

1985-01-30

Regulatory Status

Discontinued

1984
31 Jan
Discontinued Application: 18916

Drug Name

HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

9

Dosage Form

-

Strength

5,000 UNITS/100ML

Approval Date

1984-01-31

18916 / 9

Active Ingredient

HEPARIN SODIUM

Application Number

18916

Product Number

9

Dosage Form

-

Strength

5,000 UNITS/100ML

Approval Date

1984-01-31

Regulatory Status

Discontinued

1985
30 Jan
Discontinued Application: 18911

Drug Name

HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.45%

Product Number

2

Dosage Form

-

Strength

100 UNITS/ML

Approval Date

1985-01-30

18911 / 2

Active Ingredient

HEPARIN SODIUM

Application Number

18911

Product Number

2

Dosage Form

-

Strength

100 UNITS/ML

Approval Date

1985-01-30

Regulatory Status

Discontinued

1984
31 Jan
Discontinued Application: 18916

Drug Name

HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.45%

Product Number

4

Dosage Form

-

Strength

100 UNITS/ML

Approval Date

1984-01-31

18916 / 4

Active Ingredient

HEPARIN SODIUM

Application Number

18916

Product Number

4

Dosage Form

-

Strength

100 UNITS/ML

Approval Date

1984-01-31

Regulatory Status

Discontinued

1984
31 Jan
Discontinued Application: 18916

Drug Name

HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9%

Product Number

1

Dosage Form

-

Strength

1,000 UNITS/100ML

Approval Date

1984-01-31

18916 / 1

Active Ingredient

HEPARIN SODIUM

Application Number

18916

Product Number

1

Dosage Form

-

Strength

1,000 UNITS/100ML

Approval Date

1984-01-31

Regulatory Status

Discontinued

1986
07 Apr
Discontinued Application: 5264

Drug Name

HEPARIN SODIUM PRESERVATIVE FREE

Product Number

13

Dosage Form

-

Strength

2,000 UNITS/ML

Approval Date

1986-04-07

5264 / 13

Active Ingredient

HEPARIN SODIUM

Application Number

5264

Product Number

13

Dosage Form

-

Strength

2,000 UNITS/ML

Approval Date

1986-04-07

Regulatory Status

Discontinued

1986
07 Apr
Discontinued Application: 5264

Drug Name

HEPARIN SODIUM PRESERVATIVE FREE

Product Number

14

Dosage Form

-

Strength

2,500 UNITS/ML

Approval Date

1986-04-07

5264 / 14

Active Ingredient

HEPARIN SODIUM

Application Number

5264

Product Number

14

Dosage Form

-

Strength

2,500 UNITS/ML

Approval Date

1986-04-07

Regulatory Status

Discontinued

1987
04 May
RX Application: 89522

Drug Name

HEPARIN SODIUM PRESERVATIVE FREE

Product Number

1

Dosage Form

-

Strength

10,000 UNITS/ML

Approval Date

1987-05-04

89522 / 1

Active Ingredient

HEPARIN SODIUM

Application Number

89522

Product Number

1

Dosage Form

-

Strength

10,000 UNITS/ML

Approval Date

1987-05-04

Regulatory Status

RX

1997
19 Jun
Discontinued Application: 74598

Drug Name

HYDROMORPHONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1997-06-19

74598 / 1

Active Ingredient

HYDROMORPHONE HYDROCHLORIDE

Application Number

74598

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1997-06-19

Regulatory Status

Discontinued

2008
17 Jun
RX Application: 78591

Drug Name

HYDROMORPHONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2008-06-17

78591 / 1

Active Ingredient

HYDROMORPHONE HYDROCHLORIDE

Application Number

78591

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2008-06-17

Regulatory Status

RX

2011
01 Dec
RX Application: 200403

Drug Name

HYDROMORPHONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2011-12-01

200403 / 1

Active Ingredient

HYDROMORPHONE HYDROCHLORIDE

Application Number

200403

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2011-12-01

Regulatory Status

RX

2011
01 Dec
RX Application: 200403

Drug Name

HYDROMORPHONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

2MG/ML

Approval Date

2011-12-01

200403 / 2

Active Ingredient

HYDROMORPHONE HYDROCHLORIDE

Application Number

200403

Product Number

2

Dosage Form

-

Strength

2MG/ML

Approval Date

2011-12-01

Regulatory Status

RX

2011
01 Dec
RX Application: 200403

Drug Name

HYDROMORPHONE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

4MG/ML

Approval Date

2011-12-01

200403 / 3

Active Ingredient

HYDROMORPHONE HYDROCHLORIDE

Application Number

200403

Product Number

3

Dosage Form

-

Strength

4MG/ML

Approval Date

2011-12-01

Regulatory Status

RX

2022
13 Jun
RX Application: 200403

Drug Name

HYDROMORPHONE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

0.5MG/0.5ML

Approval Date

2022-06-13

200403 / 4

Active Ingredient

HYDROMORPHONE HYDROCHLORIDE

Application Number

200403

Product Number

4

Dosage Form

-

Strength

0.5MG/0.5ML

Approval Date

2022-06-13

Regulatory Status

RX

2023
03 Mar
RX Application: 200403

Drug Name

HYDROMORPHONE HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

0.25MG/0.5ML

Approval Date

2023-03-03

200403 / 5

Active Ingredient

HYDROMORPHONE HYDROCHLORIDE

Application Number

200403

Product Number

5

Dosage Form

-

Strength

0.25MG/0.5ML

Approval Date

2023-03-03

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 86821

Drug Name

HYDROXYZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

1982-01-01

86821 / 1

Active Ingredient

HYDROXYZINE HYDROCHLORIDE

Application Number

86821

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 87416

Drug Name

HYDROXYZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG/ML

Approval Date

1982-01-01

87416 / 1

Active Ingredient

HYDROXYZINE HYDROCHLORIDE

Application Number

87416

Product Number

1

Dosage Form

-

Strength

25MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 87546

Drug Name

HYDROXYZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

1982-01-01

87546 / 1

Active Ingredient

HYDROXYZINE HYDROCHLORIDE

Application Number

87546

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

2011
16 Nov
Discontinued Application: 90825

Drug Name

IMIPENEM AND CILASTATIN

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE/VIAL;250MG/VIAL

Approval Date

2011-11-16

90825 / 1

Active Ingredient

CILASTATIN SODIUM; IMIPENEM

Application Number

90825

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE/VIAL;250MG/VIAL

Approval Date

2011-11-16

Regulatory Status

Discontinued

2011
16 Nov
Discontinued Application: 90825

Drug Name

IMIPENEM AND CILASTATIN

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/VIAL;500MG/VIAL

Approval Date

2011-11-16

90825 / 2

Active Ingredient

CILASTATIN SODIUM; IMIPENEM

Application Number

90825

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/VIAL;500MG/VIAL

Approval Date

2011-11-16

Regulatory Status

Discontinued

2011
16 Nov
Discontinued Application: 91007

Drug Name

IMIPENEM AND CILASTATIN

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL;500MG/VIAL

Approval Date

2011-11-16

91007 / 1

Active Ingredient

CILASTATIN SODIUM; IMIPENEM

Application Number

91007

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL;500MG/VIAL

Approval Date

2011-11-16

Regulatory Status

Discontinued

2016
19 Apr
Discontinued Application: 204118

Drug Name

INDOMETHACIN SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/VIAL

Approval Date

2016-04-19

204118 / 1

Active Ingredient

INDOMETHACIN SODIUM

Application Number

204118

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/VIAL

Approval Date

2016-04-19

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17395

Drug Name

INTROPIN

Product Number

1

Dosage Form

-

Strength

40MG/ML

Approval Date

1982-01-01

17395 / 1

Active Ingredient

DOPAMINE HYDROCHLORIDE

Application Number

17395

Product Number

1

Dosage Form

-

Strength

40MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17395

Drug Name

INTROPIN

Product Number

2

Dosage Form

-

Strength

80MG/ML

Approval Date

1982-01-01

17395 / 2

Active Ingredient

DOPAMINE HYDROCHLORIDE

Application Number

17395

Product Number

2

Dosage Form

-

Strength

80MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17395

Drug Name

INTROPIN

Product Number

3

Dosage Form

-

Strength

160MG/ML

Approval Date

1982-01-01

17395 / 3

Active Ingredient

DOPAMINE HYDROCHLORIDE

Application Number

17395

Product Number

3

Dosage Form

-

Strength

160MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1986
08 May
Discontinued Application: 19515

Drug Name

IONOSOL B AND DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

5GM/100ML;53MG/100ML;100MG/100ML;100MG/100ML;180MG/100ML;280MG/100ML;16MG/100ML

Approval Date

1986-05-08

19515 / 1

Active Ingredient

DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE; SODIUM LACTATE; SODIUM PHOSPHATE, MONOBASIC ANHYDROUS

Application Number

19515

Product Number

1

Dosage Form

-

Strength

5GM/100ML;53MG/100ML;100MG/100ML;100MG/100ML;180MG/100ML;280MG/100ML;16MG/100ML

Approval Date

1986-05-08

Regulatory Status

Discontinued

1986
08 May
Discontinued Application: 19514

Drug Name

IONOSOL T AND DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

5GM/100ML;111MG/100ML;256MG/100ML;146MG/100ML;207MG/100ML

Approval Date

1986-05-08

19514 / 1

Active Ingredient

DEXTROSE; POTASSIUM CHLORIDE; POTASSIUM LACTATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, MONOBASIC ANHYDROUS

Application Number

19514

Product Number

1

Dosage Form

-

Strength

5GM/100ML;111MG/100ML;256MG/100ML;146MG/100ML;207MG/100ML

Approval Date

1986-05-08

Regulatory Status

Discontinued

1996
10 Dec
Discontinued Application: 74734

Drug Name

IOPAMIDOL

Product Number

1

Dosage Form

-

Strength

61%

Approval Date

1996-12-10

74734 / 1

Active Ingredient

IOPAMIDOL

Application Number

74734

Product Number

1

Dosage Form

-

Strength

61%

Approval Date

1996-12-10

Regulatory Status

Discontinued

1996
10 Dec
Discontinued Application: 74734

Drug Name

IOPAMIDOL

Product Number

2

Dosage Form

-

Strength

76%

Approval Date

1996-12-10

74734 / 2

Active Ingredient

IOPAMIDOL

Application Number

74734

Product Number

2

Dosage Form

-

Strength

76%

Approval Date

1996-12-10

Regulatory Status

Discontinued

1997
30 Dec
Discontinued Application: 74898

Drug Name

IOPAMIDOL-200

Product Number

1

Dosage Form

-

Strength

41%

Approval Date

1997-12-30

74898 / 1

Active Ingredient

IOPAMIDOL

Application Number

74898

Product Number

1

Dosage Form

-

Strength

41%

Approval Date

1997-12-30

Regulatory Status

Discontinued

1997
30 Dec
Discontinued Application: 74636

Drug Name

IOPAMIDOL-200 IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

41%

Approval Date

1997-12-30

74636 / 1

Active Ingredient

IOPAMIDOL

Application Number

74636

Product Number

1

Dosage Form

-

Strength

41%

Approval Date

1997-12-30

Regulatory Status

Discontinued

1997
30 Dec
Discontinued Application: 74898

Drug Name

IOPAMIDOL-250

Product Number

2

Dosage Form

-

Strength

51%

Approval Date

1997-12-30

74898 / 2

Active Ingredient

IOPAMIDOL

Application Number

74898

Product Number

2

Dosage Form

-

Strength

51%

Approval Date

1997-12-30

Regulatory Status

Discontinued

1998
24 Feb
Discontinued Application: 75005

Drug Name

IOPAMIDOL-250

Product Number

1

Dosage Form

-

Strength

51%

Approval Date

1998-02-24

75005 / 1

Active Ingredient

IOPAMIDOL

Application Number

75005

Product Number

1

Dosage Form

-

Strength

51%

Approval Date

1998-02-24

Regulatory Status

Discontinued

1997
30 Dec
Discontinued Application: 74636

Drug Name

IOPAMIDOL-250 IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

51%

Approval Date

1997-12-30

74636 / 2

Active Ingredient

IOPAMIDOL

Application Number

74636

Product Number

2

Dosage Form

-

Strength

51%

Approval Date

1997-12-30

Regulatory Status

Discontinued

1997
30 Dec
Discontinued Application: 74898

Drug Name

IOPAMIDOL-300

Product Number

3

Dosage Form

-

Strength

61%

Approval Date

1997-12-30

74898 / 3

Active Ingredient

IOPAMIDOL

Application Number

74898

Product Number

3

Dosage Form

-

Strength

61%

Approval Date

1997-12-30

Regulatory Status

Discontinued

1998
24 Feb
Discontinued Application: 75005

Drug Name

IOPAMIDOL-300

Product Number

2

Dosage Form

-

Strength

61%

Approval Date

1998-02-24

75005 / 2

Active Ingredient

IOPAMIDOL

Application Number

75005

Product Number

2

Dosage Form

-

Strength

61%

Approval Date

1998-02-24

Regulatory Status

Discontinued

1997
30 Dec
Discontinued Application: 74636

Drug Name

IOPAMIDOL-300 IN PLASTIC CONTAINER

Product Number

3

Dosage Form

-

Strength

61%

Approval Date

1997-12-30

74636 / 3

Active Ingredient

IOPAMIDOL

Application Number

74636

Product Number

3

Dosage Form

-

Strength

61%

Approval Date

1997-12-30

Regulatory Status

Discontinued

1997
03 Apr
Discontinued Application: 74637

Drug Name

IOPAMIDOL-300 IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

61%

Approval Date

1997-04-03

74637 / 1

Active Ingredient

IOPAMIDOL

Application Number

74637

Product Number

1

Dosage Form

-

Strength

61%

Approval Date

1997-04-03

Regulatory Status

Discontinued

1997
30 Dec
Discontinued Application: 74898

Drug Name

IOPAMIDOL-370

Product Number

4

Dosage Form

-

Strength

76%

Approval Date

1997-12-30

74898 / 4

Active Ingredient

IOPAMIDOL

Application Number

74898

Product Number

4

Dosage Form

-

Strength

76%

Approval Date

1997-12-30

Regulatory Status

Discontinued

1998
24 Feb
Discontinued Application: 75005

Drug Name

IOPAMIDOL-370

Product Number

3

Dosage Form

-

Strength

76%

Approval Date

1998-02-24

75005 / 3

Active Ingredient

IOPAMIDOL

Application Number

75005

Product Number

3

Dosage Form

-

Strength

76%

Approval Date

1998-02-24

Regulatory Status

Discontinued

1997
30 Dec
Discontinued Application: 74636

Drug Name

IOPAMIDOL-370 IN PLASTIC CONTAINER

Product Number

4

Dosage Form

-

Strength

76%

Approval Date

1997-12-30

74636 / 4

Active Ingredient

IOPAMIDOL

Application Number

74636

Product Number

4

Dosage Form

-

Strength

76%

Approval Date

1997-12-30

Regulatory Status

Discontinued

2008
27 Feb
RX Application: 77915

Drug Name

IRINOTECAN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

40MG/2ML (20MG/ML)

Approval Date

2008-02-27

77915 / 1

Active Ingredient

IRINOTECAN HYDROCHLORIDE

Application Number

77915

Product Number

1

Dosage Form

-

Strength

40MG/2ML (20MG/ML)

Approval Date

2008-02-27

Regulatory Status

RX

2008
27 Feb
RX Application: 77915

Drug Name

IRINOTECAN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

100MG/5ML (20MG/ML)

Approval Date

2008-02-27

77915 / 2

Active Ingredient

IRINOTECAN HYDROCHLORIDE

Application Number

77915

Product Number

2

Dosage Form

-

Strength

100MG/5ML (20MG/ML)

Approval Date

2008-02-27

Regulatory Status

RX

2008
27 Feb
RX Application: 78796

Drug Name

IRINOTECAN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

500MG/25ML (20MG/ML)

Approval Date

2008-02-27

78796 / 1

Active Ingredient

IRINOTECAN HYDROCHLORIDE

Application Number

78796

Product Number

1

Dosage Form

-

Strength

500MG/25ML (20MG/ML)

Approval Date

2008-02-27

Regulatory Status

RX

1993
25 Jan
Discontinued Application: 74097

Drug Name

ISOFLURANE

Product Number

1

Dosage Form

-

Strength

99.9%

Approval Date

1993-01-25

74097 / 1

Active Ingredient

ISOFLURANE

Application Number

74097

Product Number

1

Dosage Form

-

Strength

99.9%

Approval Date

1993-01-25

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83283

Drug Name

ISOPROTERENOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.02MG/ML

Approval Date

1982-01-01

83283 / 1

Active Ingredient

ISOPROTERENOL HYDROCHLORIDE

Application Number

83283

Product Number

1

Dosage Form

-

Strength

0.02MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83346

Drug Name

ISOPROTERENOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.2MG/ML

Approval Date

1982-01-01

83346 / 1

Active Ingredient

ISOPROTERENOL HYDROCHLORIDE

Application Number

83346

Product Number

1

Dosage Form

-

Strength

0.2MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1996
27 Jun
RX Application: 74549

Drug Name

KETAMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/ML

Approval Date

1996-06-27

74549 / 1

Active Ingredient

KETAMINE HYDROCHLORIDE

Application Number

74549

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/ML

Approval Date

1996-06-27

Regulatory Status

RX

1996
27 Jun
RX Application: 74549

Drug Name

KETAMINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE/ML

Approval Date

1996-06-27

74549 / 2

Active Ingredient

KETAMINE HYDROCHLORIDE

Application Number

74549

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE/ML

Approval Date

1996-06-27

Regulatory Status

RX

1997
05 Jun
Discontinued Application: 74801

Drug Name

KETOROLAC TROMETHAMINE

Product Number

1

Dosage Form

-

Strength

15MG/ML

Approval Date

1997-06-05

74801 / 1

Active Ingredient

KETOROLAC TROMETHAMINE

Application Number

74801

Product Number

1

Dosage Form

-

Strength

15MG/ML

Approval Date

1997-06-05

Regulatory Status

Discontinued

1997
05 Jun
Discontinued Application: 74801

Drug Name

KETOROLAC TROMETHAMINE

Product Number

2

Dosage Form

-

Strength

30MG/ML

Approval Date

1997-06-05

74801 / 2

Active Ingredient

KETOROLAC TROMETHAMINE

Application Number

74801

Product Number

2

Dosage Form

-

Strength

30MG/ML

Approval Date

1997-06-05

Regulatory Status

Discontinued

1997
05 Jun
RX Application: 74802

Drug Name

KETOROLAC TROMETHAMINE

Product Number

1

Dosage Form

-

Strength

15MG/ML

Approval Date

1997-06-05

74802 / 1

Active Ingredient

KETOROLAC TROMETHAMINE

Application Number

74802

Product Number

1

Dosage Form

-

Strength

15MG/ML

Approval Date

1997-06-05

Regulatory Status

RX

1997
05 Jun
RX Application: 74802

Drug Name

KETOROLAC TROMETHAMINE

Product Number

2

Dosage Form

-

Strength

30MG/ML

Approval Date

1997-06-05

74802 / 2

Active Ingredient

KETOROLAC TROMETHAMINE

Application Number

74802

Product Number

2

Dosage Form

-

Strength

30MG/ML

Approval Date

1997-06-05

Regulatory Status

RX

1999
27 Jan
Discontinued Application: 74993

Drug Name

KETOROLAC TROMETHAMINE

Product Number

1

Dosage Form

-

Strength

15MG/ML

Approval Date

1999-01-27

74993 / 1

Active Ingredient

KETOROLAC TROMETHAMINE

Application Number

74993

Product Number

1

Dosage Form

-

Strength

15MG/ML

Approval Date

1999-01-27

Regulatory Status

Discontinued

1999
27 Jan
Discontinued Application: 74993

Drug Name

KETOROLAC TROMETHAMINE

Product Number

2

Dosage Form

-

Strength

30MG/ML

Approval Date

1999-01-27

74993 / 2

Active Ingredient

KETOROLAC TROMETHAMINE

Application Number

74993

Product Number

2

Dosage Form

-

Strength

30MG/ML

Approval Date

1999-01-27

Regulatory Status

Discontinued

1999
29 Nov
RX Application: 75239

Drug Name

LABETALOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG/ML

Approval Date

1999-11-29

75239 / 1

Active Ingredient

LABETALOL HYDROCHLORIDE

Application Number

75239

Product Number

1

Dosage Form

-

Strength

5MG/ML

Approval Date

1999-11-29

Regulatory Status

RX

1999
29 Nov
RX Application: 75240

Drug Name

LABETALOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG/ML

Approval Date

1999-11-29

75240 / 1

Active Ingredient

LABETALOL HYDROCHLORIDE

Application Number

75240

Product Number

1

Dosage Form

-

Strength

5MG/ML

Approval Date

1999-11-29

Regulatory Status

RX

1999
30 Sep
Discontinued Application: 75242

Drug Name

LABETALOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG/ML

Approval Date

1999-09-30

75242 / 1

Active Ingredient

LABETALOL HYDROCHLORIDE

Application Number

75242

Product Number

1

Dosage Form

-

Strength

5MG/ML

Approval Date

1999-09-30

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 8107

Drug Name

LEUCOVORIN CALCIUM

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

8107 / 1

Active Ingredient

LEUCOVORIN CALCIUM

Application Number

8107

Product Number

1

Dosage Form

-

Strength

EQ 3MG BASE/ML (EQ 3MG 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

1982
01 Jan
Discontinued Application: 8107

Drug Name

LEUCOVORIN CALCIUM

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

8107 / 2

Active Ingredient

LEUCOVORIN CALCIUM

Application Number

8107

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1987
30 Jan
Discontinued Application: 8107

Drug Name

LEUCOVORIN CALCIUM

Product Number

3

Dosage Form

-

Strength

EQ 60MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1987-01-30

8107 / 3

Active Ingredient

LEUCOVORIN CALCIUM

Application Number

8107

Product Number

3

Dosage Form

-

Strength

EQ 60MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1987-01-30

Regulatory Status

Discontinued

1988
23 May
Discontinued Application: 8107

Drug Name

LEUCOVORIN CALCIUM

Product Number

4

Dosage Form

-

Strength

EQ 100MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1988-05-23

8107 / 4

Active Ingredient

LEUCOVORIN CALCIUM

Application Number

8107

Product Number

4

Dosage Form

-

Strength

EQ 100MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1988-05-23

Regulatory Status

Discontinued

1989
05 Apr
Discontinued Application: 8107

Drug Name

LEUCOVORIN CALCIUM

Product Number

5

Dosage Form

-

Strength

EQ 350MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1989-04-05

8107 / 5

Active Ingredient

LEUCOVORIN CALCIUM

Application Number

8107

Product Number

5

Dosage Form

-

Strength

EQ 350MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1989-04-05

Regulatory Status

Discontinued

1997
25 Jun
Discontinued Application: 40147

Drug Name

LEUCOVORIN CALCIUM PRESERVATIVE FREE

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE/10ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1997-06-25

40147 / 1

Active Ingredient

LEUCOVORIN CALCIUM

Application Number

40147

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE/10ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1997-06-25

Regulatory Status

Discontinued

1997
25 Jun
Discontinued Application: 40147

Drug Name

LEUCOVORIN CALCIUM PRESERVATIVE FREE

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1997-06-25

40147 / 2

Active Ingredient

LEUCOVORIN CALCIUM

Application Number

40147

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1997-06-25

Regulatory Status

Discontinued

2012
06 Apr
RX Application: 202869

Drug Name

LEVETIRACETAM

Product Number

1

Dosage Form

-

Strength

500MG/5ML (100MG/ML)

Approval Date

2012-04-06

202869 / 1

Active Ingredient

LEVETIRACETAM

Application Number

202869

Product Number

1

Dosage Form

-

Strength

500MG/5ML (100MG/ML)

Approval Date

2012-04-06

Regulatory Status

RX

2015
12 Aug
Discontinued Application: 78577

Drug Name

LEVOFLOXACIN

Product Number

1

Dosage Form

-

Strength

EQ 500MG/20ML (EQ 25MG/ML)

Approval Date

2015-08-12

78577 / 1

Active Ingredient

LEVOFLOXACIN

Application Number

78577

Product Number

1

Dosage Form

-

Strength

EQ 500MG/20ML (EQ 25MG/ML)

Approval Date

2015-08-12

Regulatory Status

Discontinued

2015
12 Aug
Discontinued Application: 78577

Drug Name

LEVOFLOXACIN

Product Number

2

Dosage Form

-

Strength

EQ 750MG/30ML (EQ 25MG/ML)

Approval Date

2015-08-12

78577 / 2

Active Ingredient

LEVOFLOXACIN

Application Number

78577

Product Number

2

Dosage Form

-

Strength

EQ 750MG/30ML (EQ 25MG/ML)

Approval Date

2015-08-12

Regulatory Status

Discontinued

2015
03 Sep
RX Application: 78579

Drug Name

LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2015-09-03

78579 / 1

Active Ingredient

LEVOFLOXACIN

Application Number

78579

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2015-09-03

Regulatory Status

RX

2015
03 Sep
RX Application: 78579

Drug Name

LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

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

Approval Date

2015-09-03

78579 / 2

Active Ingredient

LEVOFLOXACIN

Application Number

78579

Product Number

2

Dosage Form

-

Strength

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

Approval Date

2015-09-03

Regulatory Status

RX

2015
03 Sep
RX Application: 78579

Drug Name

LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

3

Dosage Form

-

Strength

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

Approval Date

2015-09-03

78579 / 3

Active Ingredient

LEVOFLOXACIN

Application Number

78579

Product Number

3

Dosage Form

-

Strength

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

Approval Date

2015-09-03

Regulatory Status

RX

1982
01 Jan
RX Application: 7513

Drug Name

LEVOPHED

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

1982-01-01

7513 / 1

Active Ingredient

NOREPINEPHRINE BITARTRATE

Application Number

7513

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

1982-01-01

Regulatory Status

RX

1995
23 Jun
Discontinued Application: 40013

Drug Name

LIDOCAINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1995-06-23

40013 / 1

Active Ingredient

LIDOCAINE HYDROCHLORIDE

Application Number

40013

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1995-06-23

Regulatory Status

Discontinued

1995
23 Jun
RX Application: 40078

Drug Name

LIDOCAINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1995-06-23

40078 / 1

Active Ingredient

LIDOCAINE HYDROCHLORIDE

Application Number

40078

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1995-06-23

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 83158

Drug Name

LIDOCAINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1982-01-01

83158 / 1

Active Ingredient

LIDOCAINE HYDROCHLORIDE

Application Number

83158

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83158

Drug Name

LIDOCAINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

2%

Approval Date

1982-01-01

83158 / 2

Active Ingredient

LIDOCAINE HYDROCHLORIDE

Application Number

83158

Product Number

2

Dosage Form

-

Strength

2%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83158

Drug Name

LIDOCAINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

20%

Approval Date

1982-01-01

83158 / 3

Active Ingredient

LIDOCAINE HYDROCHLORIDE

Application Number

83158

Product Number

3

Dosage Form

-

Strength

20%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1984
17 May
RX Application: 88294

Drug Name

LIDOCAINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1984-05-17

88294 / 1

Active Ingredient

LIDOCAINE HYDROCHLORIDE

Application Number

88294

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1984-05-17

Regulatory Status

RX

1984
17 May
RX Application: 88328

Drug Name

LIDOCAINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

1984-05-17

88328 / 1

Active Ingredient

LIDOCAINE HYDROCHLORIDE

Application Number

88328

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

1984-05-17

Regulatory Status

RX

1984
17 May
RX Application: 88329

Drug Name

LIDOCAINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1984-05-17

88329 / 1

Active Ingredient

LIDOCAINE HYDROCHLORIDE

Application Number

88329

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1984-05-17

Regulatory Status

RX

1984
17 May
Discontinued Application: 88330

Drug Name

LIDOCAINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

1.5%

Approval Date

1984-05-17

88330 / 1

Active Ingredient

LIDOCAINE HYDROCHLORIDE

Application Number

88330

Product Number

1

Dosage Form

-

Strength

1.5%

Approval Date

1984-05-17

Regulatory Status

Discontinued

1984
17 May
Discontinued Application: 88331

Drug Name

LIDOCAINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1984-05-17

88331 / 1

Active Ingredient

LIDOCAINE HYDROCHLORIDE

Application Number

88331

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1984-05-17

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83158

Drug Name

LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5%

Product Number

5

Dosage Form

-

Strength

200MG/100ML

Approval Date

1982-01-01

83158 / 5

Active Ingredient

LIDOCAINE HYDROCHLORIDE

Application Number

83158

Product Number

5

Dosage Form

-

Strength

200MG/100ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 18388

Drug Name

LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

200MG/100ML

Approval Date

1982-01-01

18388 / 1

Active Ingredient

LIDOCAINE HYDROCHLORIDE

Application Number

18388

Product Number

1

Dosage Form

-

Strength

200MG/100ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83158

Drug Name

LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5%

Product Number

6

Dosage Form

-

Strength

400MG/100ML

Approval Date

1982-01-01

83158 / 6

Active Ingredient

LIDOCAINE HYDROCHLORIDE

Application Number

83158

Product Number

6

Dosage Form

-

Strength

400MG/100ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 18388

Drug Name

LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

400MG/100ML

Approval Date

1982-01-01

18388 / 2

Active Ingredient

LIDOCAINE HYDROCHLORIDE

Application Number

18388

Product Number

2

Dosage Form

-

Strength

400MG/100ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
05 Nov
Discontinued Application: 18388

Drug Name

LIDOCAINE HYDROCHLORIDE 0.8% IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

3

Dosage Form

-

Strength

800MG/100ML

Approval Date

1982-11-05

18388 / 3

Active Ingredient

LIDOCAINE HYDROCHLORIDE

Application Number

18388

Product Number

3

Dosage Form

-

Strength

800MG/100ML

Approval Date

1982-11-05

Regulatory Status

Discontinued

1982
01 Jan
RX Application: 83914

Drug Name

LIDOCAINE HYDROCHLORIDE 5% AND DEXTROSE 7.5%

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

1982-01-01

83914 / 1

Active Ingredient

LIDOCAINE HYDROCHLORIDE

Application Number

83914

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

1982-01-01

Regulatory Status

RX

2008
12 May
Discontinued Application: 78772

Drug Name

LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE

Product Number

1

Dosage Form

-

Strength

0.01MG/ML;2%

Approval Date

2008-05-12

78772 / 1

Active Ingredient

EPINEPHRINE; LIDOCAINE HYDROCHLORIDE

Application Number

78772

Product Number

1

Dosage Form

-

Strength

0.01MG/ML;2%

Approval Date

2008-05-12

Regulatory Status

Discontinued

2008
12 May
Discontinued Application: 78772

Drug Name

LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE

Product Number

2

Dosage Form

-

Strength

0.02MG/ML;2%

Approval Date

2008-05-12

78772 / 2

Active Ingredient

EPINEPHRINE; LIDOCAINE HYDROCHLORIDE

Application Number

78772

Product Number

2

Dosage Form

-

Strength

0.02MG/ML;2%

Approval Date

2008-05-12

Regulatory Status

Discontinued

1985
13 Sep
RX Application: 88571

Drug Name

LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE

Product Number

1

Dosage Form

-

Strength

0.005MG/ML;1.5%

Approval Date

1985-09-13

88571 / 1

Active Ingredient

EPINEPHRINE; LIDOCAINE HYDROCHLORIDE

Application Number

88571

Product Number

1

Dosage Form

-

Strength

0.005MG/ML;1.5%

Approval Date

1985-09-13

Regulatory Status

RX

1988
21 Jun
RX Application: 89635

Drug Name

LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE

Product Number

1

Dosage Form

-

Strength

0.005MG/ML;0.5%

Approval Date

1988-06-21

89635 / 1

Active Ingredient

EPINEPHRINE; LIDOCAINE HYDROCHLORIDE

Application Number

89635

Product Number

1

Dosage Form

-

Strength

0.005MG/ML;0.5%

Approval Date

1988-06-21

Regulatory Status

RX

1988
21 Jun
RX Application: 89644

Drug Name

LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE

Product Number

1

Dosage Form

-

Strength

0.01MG/ML;1%

Approval Date

1988-06-21

89644 / 1

Active Ingredient

EPINEPHRINE; LIDOCAINE HYDROCHLORIDE

Application Number

89644

Product Number

1

Dosage Form

-

Strength

0.01MG/ML;1%

Approval Date

1988-06-21

Regulatory Status

RX

1988
21 Jun
RX Application: 89645

Drug Name

LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE

Product Number

1

Dosage Form

-

Strength

0.005MG/ML;1.5%

Approval Date

1988-06-21

89645 / 1

Active Ingredient

EPINEPHRINE; LIDOCAINE HYDROCHLORIDE

Application Number

89645

Product Number

1

Dosage Form

-

Strength

0.005MG/ML;1.5%

Approval Date

1988-06-21

Regulatory Status

RX

1988
21 Jun
RX Application: 89646

Drug Name

LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE

Product Number

1

Dosage Form

-

Strength

0.01MG/ML;2%

Approval Date

1988-06-21

89646 / 1

Active Ingredient

EPINEPHRINE; LIDOCAINE HYDROCHLORIDE

Application Number

89646

Product Number

1

Dosage Form

-

Strength

0.01MG/ML;2%

Approval Date

1988-06-21

Regulatory Status

RX

1988
21 Jun
Discontinued Application: 89649

Drug Name

LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE

Product Number

1

Dosage Form

-

Strength

0.005MG/ML;1%

Approval Date

1988-06-21

89649 / 1

Active Ingredient

EPINEPHRINE; LIDOCAINE HYDROCHLORIDE

Application Number

89649

Product Number

1

Dosage Form

-

Strength

0.005MG/ML;1%

Approval Date

1988-06-21

Regulatory Status

Discontinued

1988
21 Jun
Discontinued Application: 89650

Drug Name

LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE

Product Number

1

Dosage Form

-

Strength

0.005MG/ML;1.5%

Approval Date

1988-06-21

89650 / 1

Active Ingredient

EPINEPHRINE; LIDOCAINE HYDROCHLORIDE

Application Number

89650

Product Number

1

Dosage Form

-

Strength

0.005MG/ML;1.5%

Approval Date

1988-06-21

Regulatory Status

Discontinued

1988
21 Jun
RX Application: 89651

Drug Name

LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE

Product Number

1

Dosage Form

-

Strength

0.005MG/ML;2%

Approval Date

1988-06-21

89651 / 1

Active Ingredient

EPINEPHRINE; LIDOCAINE HYDROCHLORIDE

Application Number

89651

Product Number

1

Dosage Form

-

Strength

0.005MG/ML;2%

Approval Date

1988-06-21

Regulatory Status

RX

1984
31 Jul
RX Application: 88299

Drug Name

LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1984-07-31

88299 / 1

Active Ingredient

LIDOCAINE HYDROCHLORIDE

Application Number

88299

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1984-07-31

Regulatory Status

RX

1984
31 Jul
RX Application: 88325

Drug Name

LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

1984-07-31

88325 / 1

Active Ingredient

LIDOCAINE HYDROCHLORIDE

Application Number

88325

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

1984-07-31

Regulatory Status

RX

1984
31 Jul
Discontinued Application: 88326

Drug Name

LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

1.5%

Approval Date

1984-07-31

88326 / 1

Active Ingredient

LIDOCAINE HYDROCHLORIDE

Application Number

88326

Product Number

1

Dosage Form

-

Strength

1.5%

Approval Date

1984-07-31

Regulatory Status

Discontinued

1984
31 Jul
RX Application: 88327

Drug Name

LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1984-07-31

88327 / 1

Active Ingredient

LIDOCAINE HYDROCHLORIDE

Application Number

88327

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1984-07-31

Regulatory Status

RX

1984
31 Jul
Discontinued Application: 88367

Drug Name

LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

10%

Approval Date

1984-07-31

88367 / 1

Active Ingredient

LIDOCAINE HYDROCHLORIDE

Application Number

88367

Product Number

1

Dosage Form

-

Strength

10%

Approval Date

1984-07-31

Regulatory Status

Discontinued

1984
31 Jul
Discontinued Application: 88368

Drug Name

LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

20%

Approval Date

1984-07-31

88368 / 1

Active Ingredient

LIDOCAINE HYDROCHLORIDE

Application Number

88368

Product Number

1

Dosage Form

-

Strength

20%

Approval Date

1984-07-31

Regulatory Status

Discontinued

1982
01 Jan
RX Application: 80408

Drug Name

LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1982-01-01

80408 / 1

Active Ingredient

LIDOCAINE HYDROCHLORIDE

Application Number

80408

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 80408

Drug Name

LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE

Product Number

2

Dosage Form

-

Strength

1.5%

Approval Date

1982-01-01

80408 / 2

Active Ingredient

LIDOCAINE HYDROCHLORIDE

Application Number

80408

Product Number

2

Dosage Form

-

Strength

1.5%

Approval Date

1982-01-01

Regulatory Status

RX

1984
17 May
RX Application: 88295

Drug Name

LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE

Product Number

1

Dosage Form

-

Strength

4%

Approval Date

1984-05-17

88295 / 1

Active Ingredient

LIDOCAINE HYDROCHLORIDE

Application Number

88295

Product Number

1

Dosage Form

-

Strength

4%

Approval Date

1984-05-17

Regulatory Status

RX

1998
28 Sep
RX Application: 40302

Drug Name

LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1998-09-28

40302 / 1

Active Ingredient

LIDOCAINE HYDROCHLORIDE

Application Number

40302

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1998-09-28

Regulatory Status

RX

1998
28 Sep
RX Application: 40302

Drug Name

LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

2%

Approval Date

1998-09-28

40302 / 2

Active Ingredient

LIDOCAINE HYDROCHLORIDE

Application Number

40302

Product Number

2

Dosage Form

-

Strength

2%

Approval Date

1998-09-28

Regulatory Status

RX

2015
07 Jul
Discontinued Application: 205442

Drug Name

LINEZOLID

Product Number

1

Dosage Form

-

Strength

600MG/300ML (2MG/ML)

Approval Date

2015-07-07

205442 / 1

Active Ingredient

LINEZOLID

Application Number

205442

Product Number

1

Dosage Form

-

Strength

600MG/300ML (2MG/ML)

Approval Date

2015-07-07

Regulatory Status

Discontinued

2015
18 Jun
RX Application: 206473

Drug Name

LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

600MG/300ML (2MG/ML)

Approval Date

2015-06-18

206473 / 1

Active Ingredient

LINEZOLID

Application Number

206473

Product Number

1

Dosage Form

-

Strength

600MG/300ML (2MG/ML)

Approval Date

2015-06-18

Regulatory Status

RX

1984
27 Aug
Discontinued Application: 18997

Drug Name

LIPOSYN II 10%

Product Number

1

Dosage Form

-

Strength

5%;5% (5GM/100ML)

Approval Date

1984-08-27

18997 / 1

Active Ingredient

SAFFLOWER OIL; SOYBEAN OIL

Application Number

18997

Product Number

1

Dosage Form

-

Strength

5%;5% (5GM/100ML)

Approval Date

1984-08-27

Regulatory Status

Discontinued

1984
27 Aug
Discontinued Application: 18991

Drug Name

LIPOSYN II 20%

Product Number

1

Dosage Form

-

Strength

10%;10% (10GM/100ML)

Approval Date

1984-08-27

18991 / 1

Active Ingredient

SAFFLOWER OIL; SOYBEAN OIL

Application Number

18991

Product Number

1

Dosage Form

-

Strength

10%;10% (10GM/100ML)

Approval Date

1984-08-27

Regulatory Status

Discontinued

1984
24 Sep
Discontinued Application: 18969

Drug Name

LIPOSYN III 10%

Product Number

1

Dosage Form

-

Strength

10%

Approval Date

1984-09-24

18969 / 1

Active Ingredient

SOYBEAN OIL

Application Number

18969

Product Number

1

Dosage Form

-

Strength

10%

Approval Date

1984-09-24

Regulatory Status

Discontinued

1984
25 Sep
Discontinued Application: 18970

Drug Name

LIPOSYN III 20%

Product Number

1

Dosage Form

-

Strength

20%

Approval Date

1984-09-25

18970 / 1

Active Ingredient

SOYBEAN OIL

Application Number

18970

Product Number

1

Dosage Form

-

Strength

20%

Approval Date

1984-09-25

Regulatory Status

Discontinued

1998
13 Jan
Discontinued Application: 20181

Drug Name

LIPOSYN III 30%

Product Number

1

Dosage Form

-

Strength

30%

Approval Date

1998-01-13

20181 / 1

Active Ingredient

SOYBEAN OIL

Application Number

20181

Product Number

1

Dosage Form

-

Strength

30%

Approval Date

1998-01-13

Regulatory Status

Discontinued

1994
12 Apr
RX Application: 74243

Drug Name

LORAZEPAM

Product Number

1

Dosage Form

-

Strength

2MG/ML

Approval Date

1994-04-12

74243 / 1

Active Ingredient

LORAZEPAM

Application Number

74243

Product Number

1

Dosage Form

-

Strength

2MG/ML

Approval Date

1994-04-12

Regulatory Status

RX

1994
12 Apr
RX Application: 74243

Drug Name

LORAZEPAM

Product Number

2

Dosage Form

-

Strength

4MG/ML

Approval Date

1994-04-12

74243 / 2

Active Ingredient

LORAZEPAM

Application Number

74243

Product Number

2

Dosage Form

-

Strength

4MG/ML

Approval Date

1994-04-12

Regulatory Status

RX

1994
27 May
Discontinued Application: 74280

Drug Name

LORAZEPAM

Product Number

1

Dosage Form

-

Strength

2MG/ML

Approval Date

1994-05-27

74280 / 1

Active Ingredient

LORAZEPAM

Application Number

74280

Product Number

1

Dosage Form

-

Strength

2MG/ML

Approval Date

1994-05-27

Regulatory Status

Discontinued

1994
27 May
Discontinued Application: 74280

Drug Name

LORAZEPAM

Product Number

2

Dosage Form

-

Strength

4MG/ML

Approval Date

1994-05-27

74280 / 2

Active Ingredient

LORAZEPAM

Application Number

74280

Product Number

2

Dosage Form

-

Strength

4MG/ML

Approval Date

1994-05-27

Regulatory Status

Discontinued

1994
27 May
Discontinued Application: 74282

Drug Name

LORAZEPAM

Product Number

1

Dosage Form

-

Strength

2MG/ML

Approval Date

1994-05-27

74282 / 1

Active Ingredient

LORAZEPAM

Application Number

74282

Product Number

1

Dosage Form

-

Strength

2MG/ML

Approval Date

1994-05-27

Regulatory Status

Discontinued

1994
27 May
Discontinued Application: 74282

Drug Name

LORAZEPAM

Product Number

2

Dosage Form

-

Strength

4MG/ML

Approval Date

1994-05-27

74282 / 2

Active Ingredient

LORAZEPAM

Application Number

74282

Product Number

2

Dosage Form

-

Strength

4MG/ML

Approval Date

1994-05-27

Regulatory Status

Discontinued

1994
12 Apr
Discontinued Application: 74300

Drug Name

LORAZEPAM

Product Number

1

Dosage Form

-

Strength

2MG/ML

Approval Date

1994-04-12

74300 / 1

Active Ingredient

LORAZEPAM

Application Number

74300

Product Number

1

Dosage Form

-

Strength

2MG/ML

Approval Date

1994-04-12

Regulatory Status

Discontinued

1997
19 Mar
Discontinued Application: 74300

Drug Name

LORAZEPAM

Product Number

3

Dosage Form

-

Strength

4MG/ML

Approval Date

1997-03-19

74300 / 3

Active Ingredient

LORAZEPAM

Application Number

74300

Product Number

3

Dosage Form

-

Strength

4MG/ML

Approval Date

1997-03-19

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 80409

Drug Name

LTA II KIT

Product Number

1

Dosage Form

-

Strength

4%

Approval Date

1982-01-01

80409 / 1

Active Ingredient

LIDOCAINE HYDROCHLORIDE

Application Number

80409

Product Number

1

Dosage Form

-

Strength

4%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1984
31 Jul
Discontinued Application: 88542

Drug Name

LTA II KIT

Product Number

1

Dosage Form

-

Strength

4%

Approval Date

1984-07-31

88542 / 1

Active Ingredient

LIDOCAINE HYDROCHLORIDE

Application Number

88542

Product Number

1

Dosage Form

-

Strength

4%

Approval Date

1984-07-31

Regulatory Status

Discontinued

2004
30 Jan
Discontinued Application: 21625

Drug Name

M.V.I. ADULT

Product Number

1

Dosage Form

-

Strength

200MG/VIAL;0.06MG/VIAL;0.005MG/VIAL;15MG/VIAL;0.005MG/VIAL;0.6MG/VIAL;40MG/VIAL;6MG/VIAL;3.6MG/VIAL;6MG/VIAL;1MG/VIAL;10MG/VIAL;0.15MG/VIAL

Approval Date

2004-01-30

21625 / 1

Active Ingredient

ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E; VITAMIN K

Application Number

21625

Product Number

1

Dosage Form

-

Strength

200MG/VIAL;0.06MG/VIAL;0.005MG/VIAL;15MG/VIAL;0.005MG/VIAL;0.6MG/VIAL;40MG/VIAL;6MG/VIAL;3.6MG/VIAL;6MG/VIAL;1MG/VIAL;10MG/VIAL;0.15MG/VIAL

Approval Date

2004-01-30

Regulatory Status

Discontinued

2004
18 Feb
Discontinued Application: 21643

Drug Name

M.V.I. ADULT (PHARMACY BULK PACKAGE)

Product Number

1

Dosage Form

-

Strength

200MG/5ML;0.06MG/5ML;0.005MG/5ML;15MG/5ML;0.005MG/5ML;0.6MG/5ML;40MG/5ML;6MG/5ML;3.6MG/5ML;6MG/5ML;1MG/5ML;10MG/5ML;0.15MG/5ML

Approval Date

2004-02-18

21643 / 1

Active Ingredient

ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E; VITAMIN K

Application Number

21643

Product Number

1

Dosage Form

-

Strength

200MG/5ML;0.06MG/5ML;0.005MG/5ML;15MG/5ML;0.005MG/5ML;0.6MG/5ML;40MG/5ML;6MG/5ML;3.6MG/5ML;6MG/5ML;1MG/5ML;10MG/5ML;0.15MG/5ML

Approval Date

2004-02-18

Regulatory Status

Discontinued

2000
21 Sep
Discontinued Application: 18920

Drug Name

M.V.I. PEDIATRIC

Product Number

1

Dosage Form

-

Strength

80MG/VIAL;0.02MG/VIAL;0.001MG/VIAL;5MG/VIAL;0.01MG/VIAL;0.14MG/VIAL;17MG/VIAL;0.2MG/VIAL;1MG/VIAL;1.4MG/VIAL;EQ 1.2MG BASE/VIAL;0.7MG/VIAL;7MG/VIAL

Approval Date

2000-09-21

18920 / 1

Active Ingredient

ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PHYTONADIONE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E

Application Number

18920

Product Number

1

Dosage Form

-

Strength

80MG/VIAL;0.02MG/VIAL;0.001MG/VIAL;5MG/VIAL;0.01MG/VIAL;0.14MG/VIAL;17MG/VIAL;0.2MG/VIAL;1MG/VIAL;1.4MG/VIAL;EQ 1.2MG BASE/VIAL;0.7MG/VIAL;7MG/VIAL

Approval Date

2000-09-21

Regulatory Status

Discontinued

1985
08 Aug
Discontinued Application: 8809

Drug Name

M.V.I.-12 ADULT

Product Number

4

Dosage Form

-

Strength

10MG/ML;0.006MG/ML;0.5MCG/ML;1.5MG/ML;20 IU/ML;0.04MG/ML;4MG/ML;0.4MG/ML;0.36MG/ML;0.3MG/ML;330 UNITS/ML;1 IU/ML

Approval Date

1985-08-08

8809 / 4

Active Ingredient

ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E

Application Number

8809

Product Number

4

Dosage Form

-

Strength

10MG/ML;0.006MG/ML;0.5MCG/ML;1.5MG/ML;20 IU/ML;0.04MG/ML;4MG/ML;0.4MG/ML;0.36MG/ML;0.3MG/ML;330 UNITS/ML;1 IU/ML

Approval Date

1985-08-08

Regulatory Status

Discontinued

2004
22 Apr
Discontinued Application: 8809

Drug Name

M.V.I.-12 ADULT

Product Number

5

Dosage Form

-

Strength

20MG/ML;0.006MG/ML;0.5MCG/ML;1.5MG/ML;20 IU/ML;0.6MG/ML;4MG/ML;0.4MG/ML;0.36MG/ML;0.6MG/ML;330 UNITS/ML;1 IU/ML

Approval Date

2004-04-22

8809 / 5

Active Ingredient

ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E

Application Number

8809

Product Number

5

Dosage Form

-

Strength

20MG/ML;0.006MG/ML;0.5MCG/ML;1.5MG/ML;20 IU/ML;0.6MG/ML;4MG/ML;0.4MG/ML;0.36MG/ML;0.6MG/ML;330 UNITS/ML;1 IU/ML

Approval Date

2004-04-22

Regulatory Status

Discontinued

2004
09 Sep
Discontinued Application: 8809

Drug Name

M.V.I.-12 ADULT

Product Number

6

Dosage Form

-

Strength

20MG/ML;0.006MG/ML;0.05MCG/ML;1.5MG/ML;0.0005MG/ML;0.06MG/ML;4MG/ML;0.6MG/ML;0.36MG/ML;0.6MG/ML;0.1MG/ML;1MG/ML

Approval Date

2004-09-09

8809 / 6

Active Ingredient

ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E

Application Number

8809

Product Number

6

Dosage Form

-

Strength

20MG/ML;0.006MG/ML;0.05MCG/ML;1.5MG/ML;0.0005MG/ML;0.06MG/ML;4MG/ML;0.6MG/ML;0.36MG/ML;0.6MG/ML;0.1MG/ML;1MG/ML

Approval Date

2004-09-09

Regulatory Status

Discontinued

2000
25 Apr
RX Application: 75151

Drug Name

MAGNESIUM SULFATE

Product Number

1

Dosage Form

-

Strength

5GM/10ML (500MG/ML)

Approval Date

2000-04-25

75151 / 1

Active Ingredient

MAGNESIUM SULFATE

Application Number

75151

Product Number

1

Dosage Form

-

Strength

5GM/10ML (500MG/ML)

Approval Date

2000-04-25

Regulatory Status

RX

2015
14 May
RX Application: 202411

Drug Name

MAGNESIUM SULFATE

Product Number

1

Dosage Form

-

Strength

10GM/20ML (500MG/ML)

Approval Date

2015-05-14

202411 / 1

Active Ingredient

MAGNESIUM SULFATE

Application Number

202411

Product Number

1

Dosage Form

-

Strength

10GM/20ML (500MG/ML)

Approval Date

2015-05-14

Regulatory Status

RX

1995
11 Jul
RX Application: 20488

Drug Name

MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

1GM/100ML

Approval Date

1995-07-11

20488 / 1

Active Ingredient

MAGNESIUM SULFATE

Application Number

20488

Product Number

1

Dosage Form

-

Strength

1GM/100ML

Approval Date

1995-07-11

Regulatory Status

RX

1995
11 Jul
RX Application: 20488

Drug Name

MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

2GM/100ML

Approval Date

1995-07-11

20488 / 2

Active Ingredient

MAGNESIUM SULFATE

Application Number

20488

Product Number

2

Dosage Form

-

Strength

2GM/100ML

Approval Date

1995-07-11

Regulatory Status

RX

1994
24 Jun
RX Application: 20309

Drug Name

MAGNESIUM SULFATE IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

4GM/100ML (40MG/ML)

Approval Date

1994-06-24

20309 / 1

Active Ingredient

MAGNESIUM SULFATE

Application Number

20309

Product Number

1

Dosage Form

-

Strength

4GM/100ML (40MG/ML)

Approval Date

1994-06-24

Regulatory Status

RX

1994
24 Jun
RX Application: 20309

Drug Name

MAGNESIUM SULFATE IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

4GM/50ML (80MG/ML)

Approval Date

1994-06-24

20309 / 2

Active Ingredient

MAGNESIUM SULFATE

Application Number

20309

Product Number

2

Dosage Form

-

Strength

4GM/50ML (80MG/ML)

Approval Date

1994-06-24

Regulatory Status

RX

2007
26 Jan
RX Application: 20309

Drug Name

MAGNESIUM SULFATE IN PLASTIC CONTAINER

Product Number

3

Dosage Form

-

Strength

2GM/50ML (40MG/ML)

Approval Date

2007-01-26

20309 / 3

Active Ingredient

MAGNESIUM SULFATE

Application Number

20309

Product Number

3

Dosage Form

-

Strength

2GM/50ML (40MG/ML)

Approval Date

2007-01-26

Regulatory Status

RX

1995
18 Jan
RX Application: 20309

Drug Name

MAGNESIUM SULFATE IN PLASTIC CONTAINER

Product Number

4

Dosage Form

-

Strength

20GM/500ML (40MG/ML)

Approval Date

1995-01-18

20309 / 4

Active Ingredient

MAGNESIUM SULFATE

Application Number

20309

Product Number

4

Dosage Form

-

Strength

20GM/500ML (40MG/ML)

Approval Date

1995-01-18

Regulatory Status

RX

1995
18 Jan
RX Application: 20309

Drug Name

MAGNESIUM SULFATE IN PLASTIC CONTAINER

Product Number

5

Dosage Form

-

Strength

40GM/1000ML (40MG/ML)

Approval Date

1995-01-18

20309 / 5

Active Ingredient

MAGNESIUM SULFATE

Application Number

20309

Product Number

5

Dosage Form

-

Strength

40GM/1000ML (40MG/ML)

Approval Date

1995-01-18

Regulatory Status

RX

1986
26 Jun
RX Application: 18962

Drug Name

MANGANESE CHLORIDE IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

EQ 0.1MG MANGANESE/ML

Approval Date

1986-06-26

18962 / 1

Active Ingredient

MANGANESE CHLORIDE

Application Number

18962

Product Number

1

Dosage Form

-

Strength

EQ 0.1MG MANGANESE/ML

Approval Date

1986-06-26

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 16269

Drug Name

MANNITOL 10%

Product Number

2

Dosage Form

-

Strength

10GM/100ML

Approval Date

1982-01-01

16269 / 2

Active Ingredient

MANNITOL

Application Number

16269

Product Number

2

Dosage Form

-

Strength

10GM/100ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 16269

Drug Name

MANNITOL 15%

Product Number

3

Dosage Form

-

Strength

15GM/100ML

Approval Date

1982-01-01

16269 / 3

Active Ingredient

MANNITOL

Application Number

16269

Product Number

3

Dosage Form

-

Strength

15GM/100ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 16269

Drug Name

MANNITOL 20%

Product Number

4

Dosage Form

-

Strength

20GM/100ML

Approval Date

1982-01-01

16269 / 4

Active Ingredient

MANNITOL

Application Number

16269

Product Number

4

Dosage Form

-

Strength

20GM/100ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 16269

Drug Name

MANNITOL 25%

Product Number

5

Dosage Form

-

Strength

12.5GM/50ML

Approval Date

1982-01-01

16269 / 5

Active Ingredient

MANNITOL

Application Number

16269

Product Number

5

Dosage Form

-

Strength

12.5GM/50ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1994
25 Aug
RX Application: 16269

Drug Name

MANNITOL 25%

Product Number

6

Dosage Form

-

Strength

12.5GM/50ML

Approval Date

1994-08-25

16269 / 6

Active Ingredient

MANNITOL

Application Number

16269

Product Number

6

Dosage Form

-

Strength

12.5GM/50ML

Approval Date

1994-08-25

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 16269

Drug Name

MANNITOL 5%

Product Number

1

Dosage Form

-

Strength

5GM/100ML

Approval Date

1982-01-01

16269 / 1

Active Ingredient

MANNITOL

Application Number

16269

Product Number

1

Dosage Form

-

Strength

5GM/100ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1984
04 May
RX Application: 18692

Drug Name

MARCAINE

Product Number

1

Dosage Form

-

Strength

0.75%

Approval Date

1984-05-04

18692 / 1

Active Ingredient

BUPIVACAINE HYDROCHLORIDE

Application Number

18692

Product Number

1

Dosage Form

-

Strength

0.75%

Approval Date

1984-05-04

Regulatory Status

RX

1982
01 Jan
RX Application: 16964

Drug Name

MARCAINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.25%

Approval Date

1982-01-01

16964 / 1

Active Ingredient

BUPIVACAINE HYDROCHLORIDE

Application Number

16964

Product Number

1

Dosage Form

-

Strength

0.25%

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 16964

Drug Name

MARCAINE HYDROCHLORIDE

Product Number

6

Dosage Form

-

Strength

0.5%

Approval Date

1982-01-01

16964 / 6

Active Ingredient

BUPIVACAINE HYDROCHLORIDE

Application Number

16964

Product Number

6

Dosage Form

-

Strength

0.5%

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 16964

Drug Name

MARCAINE HYDROCHLORIDE PRESERVATIVE FREE

Product Number

5

Dosage Form

-

Strength

0.5%

Approval Date

1982-01-01

16964 / 5

Active Ingredient

BUPIVACAINE HYDROCHLORIDE

Application Number

16964

Product Number

5

Dosage Form

-

Strength

0.5%

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 16964

Drug Name

MARCAINE HYDROCHLORIDE PRESERVATIVE FREE

Product Number

9

Dosage Form

-

Strength

0.75%

Approval Date

1982-01-01

16964 / 9

Active Ingredient

BUPIVACAINE HYDROCHLORIDE

Application Number

16964

Product Number

9

Dosage Form

-

Strength

0.75%

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 16964

Drug Name

MARCAINE HYDROCHLORIDE PRESERVATIVE FREE

Product Number

12

Dosage Form

-

Strength

0.25%

Approval Date

1982-01-01

16964 / 12

Active Ingredient

BUPIVACAINE HYDROCHLORIDE

Application Number

16964

Product Number

12

Dosage Form

-

Strength

0.25%

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 16964

Drug Name

MARCAINE HYDROCHLORIDE W/ EPINEPHRINE

Product Number

4

Dosage Form

-

Strength

0.25%;0.0091MG/ML

Approval Date

1982-01-01

16964 / 4

Active Ingredient

BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE

Application Number

16964

Product Number

4

Dosage Form

-

Strength

0.25%;0.0091MG/ML

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 16964

Drug Name

MARCAINE HYDROCHLORIDE W/ EPINEPHRINE

Product Number

8

Dosage Form

-

Strength

0.5%;0.0091MG/ML

Approval Date

1982-01-01

16964 / 8

Active Ingredient

BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE

Application Number

16964

Product Number

8

Dosage Form

-

Strength

0.5%;0.0091MG/ML

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 16964

Drug Name

MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE

Product Number

7

Dosage Form

-

Strength

0.5%;0.0091MG/ML

Approval Date

1982-01-01

16964 / 7

Active Ingredient

BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE

Application Number

16964

Product Number

7

Dosage Form

-

Strength

0.5%;0.0091MG/ML

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 16964

Drug Name

MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE

Product Number

10

Dosage Form

-

Strength

0.75%;0.0091MG/ML

Approval Date

1982-01-01

16964 / 10

Active Ingredient

BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE

Application Number

16964

Product Number

10

Dosage Form

-

Strength

0.75%;0.0091MG/ML

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 16964

Drug Name

MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE

Product Number

13

Dosage Form

-

Strength

0.25%;0.0091MG/ML

Approval Date

1982-01-01

16964 / 13

Active Ingredient

BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE

Application Number

16964

Product Number

13

Dosage Form

-

Strength

0.25%;0.0091MG/ML

Approval Date

1982-01-01

Regulatory Status

RX

1996
18 Jan
Discontinued Application: 50679

Drug Name

MAXIPIME

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

1996-01-18

50679 / 1

Active Ingredient

CEFEPIME HYDROCHLORIDE

Application Number

50679

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

1996-01-18

Regulatory Status

Discontinued

1996
18 Jan
Discontinued Application: 50679

Drug Name

MAXIPIME

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

1996-01-18

50679 / 2

Active Ingredient

CEFEPIME HYDROCHLORIDE

Application Number

50679

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

1996-01-18

Regulatory Status

Discontinued

1996
18 Jan
Discontinued Application: 50679

Drug Name

MAXIPIME

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

1996-01-18

50679 / 3

Active Ingredient

CEFEPIME HYDROCHLORIDE

Application Number

50679

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

1996-01-18

Regulatory Status

Discontinued

1999
10 Mar
Discontinued Application: 40305

Drug Name

MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1999-03-10

40305 / 1

Active Ingredient

MEPERIDINE HYDROCHLORIDE

Application Number

40305

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1999-03-10

Regulatory Status

Discontinued

2008
28 Apr
Discontinued Application: 40806

Drug Name

MEPIVACAINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

3%

Approval Date

2008-04-28

40806 / 1

Active Ingredient

MEPIVACAINE HYDROCHLORIDE

Application Number

40806

Product Number

1

Dosage Form

-

Strength

3%

Approval Date

2008-04-28

Regulatory Status

Discontinued

2010
22 Jun
Discontinued Application: 90940

Drug Name

MEROPENEM

Product Number

1

Dosage Form

-

Strength

500MG/VIAL

Approval Date

2010-06-22

90940 / 1

Active Ingredient

MEROPENEM

Application Number

90940

Product Number

1

Dosage Form

-

Strength

500MG/VIAL

Approval Date

2010-06-22

Regulatory Status

Discontinued

2010
22 Jun
Discontinued Application: 90940

Drug Name

MEROPENEM

Product Number

2

Dosage Form

-

Strength

1GM/VIAL

Approval Date

2010-06-22

90940 / 2

Active Ingredient

MEROPENEM

Application Number

90940

Product Number

2

Dosage Form

-

Strength

1GM/VIAL

Approval Date

2010-06-22

Regulatory Status

Discontinued

1982
31 Mar
Discontinued Application: 11719

Drug Name

METHOTREXATE LPF

Product Number

7

Dosage Form

-

Strength

EQ 25MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-03-31

11719 / 7

Active Ingredient

METHOTREXATE SODIUM

Application Number

11719

Product Number

7

Dosage Form

-

Strength

EQ 25MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-03-31

Regulatory Status

Discontinued

2005
13 Apr
Discontinued Application: 11719

Drug Name

METHOTREXATE PRESERVATIVE FREE

Product Number

11

Dosage Form

-

Strength

EQ 2.5GM BASE/100ML (EQ 25MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2005-04-13

11719 / 11

Active Ingredient

METHOTREXATE SODIUM

Application Number

11719

Product Number

11

Dosage Form

-

Strength

EQ 2.5GM BASE/100ML (EQ 25MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2005-04-13

Regulatory Status

Discontinued

2005
13 Apr
Discontinued Application: 11719

Drug Name

METHOTREXATE PRESERVATIVE FREE

Product Number

13

Dosage Form

-

Strength

EQ 500MG BASE/20ML (EQ 25MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2005-04-13

11719 / 13

Active Ingredient

METHOTREXATE SODIUM

Application Number

11719

Product Number

13

Dosage Form

-

Strength

EQ 500MG BASE/20ML (EQ 25MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2005-04-13

Regulatory Status

Discontinued

2005
13 Apr
Discontinued Application: 11719

Drug Name

METHOTREXATE PRESERVATIVE FREE

Product Number

14

Dosage Form

-

Strength

EQ 20MG BASE/2ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2005-04-13

11719 / 14

Active Ingredient

METHOTREXATE SODIUM

Application Number

11719

Product Number

14

Dosage Form

-

Strength

EQ 20MG BASE/2ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2005-04-13

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 11719

Drug Name

METHOTREXATE SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

11719 / 1

Active Ingredient

METHOTREXATE SODIUM

Application Number

11719

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE/VIAL **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: 11719

Drug Name

METHOTREXATE SODIUM

Product Number

3

Dosage Form

-

Strength

EQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

11719 / 3

Active Ingredient

METHOTREXATE SODIUM

Application Number

11719

Product Number

3

Dosage Form

-

Strength

EQ 50MG BASE/VIAL **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: 11719

Drug Name

METHOTREXATE SODIUM

Product Number

4

Dosage Form

-

Strength

EQ 2.5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

11719 / 4

Active Ingredient

METHOTREXATE SODIUM

Application Number

11719

Product Number

4

Dosage Form

-

Strength

EQ 2.5MG 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

1982
01 Jan
Discontinued Application: 11719

Drug Name

METHOTREXATE SODIUM

Product Number

5

Dosage Form

-

Strength

EQ 25MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

11719 / 5

Active Ingredient

METHOTREXATE SODIUM

Application Number

11719

Product Number

5

Dosage Form

-

Strength

EQ 25MG 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

1982
01 Jan
Discontinued Application: 11719

Drug Name

METHOTREXATE SODIUM

Product Number

6

Dosage Form

-

Strength

EQ 100MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

11719 / 6

Active Ingredient

METHOTREXATE SODIUM

Application Number

11719

Product Number

6

Dosage Form

-

Strength

EQ 100MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

2004
15 Dec
RX Application: 11719

Drug Name

METHOTREXATE SODIUM

Product Number

10

Dosage Form

-

Strength

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

Approval Date

2004-12-15

11719 / 10

Active Ingredient

METHOTREXATE SODIUM

Application Number

11719

Product Number

10

Dosage Form

-

Strength

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

Approval Date

2004-12-15

Regulatory Status

RX

1988
07 Apr
Discontinued Application: 11719

Drug Name

METHOTREXATE SODIUM PRESERVATIVE FREE

Product Number

9

Dosage Form

-

Strength

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

Approval Date

1988-04-07

11719 / 9

Active Ingredient

METHOTREXATE SODIUM

Application Number

11719

Product Number

9

Dosage Form

-

Strength

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

Approval Date

1988-04-07

Regulatory Status

Discontinued

2005
13 Apr
RX Application: 11719

Drug Name

METHOTREXATE SODIUM PRESERVATIVE FREE

Product Number

12

Dosage Form

-

Strength

EQ 1GM BASE/40ML (EQ 25MG BASE/ML)

Approval Date

2005-04-13

11719 / 12

Active Ingredient

METHOTREXATE SODIUM

Application Number

11719

Product Number

12

Dosage Form

-

Strength

EQ 1GM BASE/40ML (EQ 25MG BASE/ML)

Approval Date

2005-04-13

Regulatory Status

RX

1987
19 Jun
Discontinued Application: 70691

Drug Name

METHYLDOPATE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

1987-06-19

70691 / 1

Active Ingredient

METHYLDOPATE HYDROCHLORIDE

Application Number

70691

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

1987-06-19

Regulatory Status

Discontinued

1987
15 Jun
Discontinued Application: 70698

Drug Name

METHYLDOPATE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

1987-06-15

70698 / 1

Active Ingredient

METHYLDOPATE HYDROCHLORIDE

Application Number

70698

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

1987-06-15

Regulatory Status

Discontinued

1987
15 Jun
Discontinued Application: 70699

Drug Name

METHYLDOPATE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

1987-06-15

70699 / 1

Active Ingredient

METHYLDOPATE HYDROCHLORIDE

Application Number

70699

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

1987-06-15

Regulatory Status

Discontinued

1987
19 Jun
Discontinued Application: 70849

Drug Name

METHYLDOPATE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

1987-06-19

70849 / 1

Active Ingredient

METHYLDOPATE HYDROCHLORIDE

Application Number

70849

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

1987-06-19

Regulatory Status

Discontinued

1989
23 Jun
Discontinued Application: 70505

Drug Name

METOCLOPRAMIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

1989-06-23

70505 / 1

Active Ingredient

METOCLOPRAMIDE HYDROCHLORIDE

Application Number

70505

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

1989-06-23

Regulatory Status

Discontinued

1989
22 Jun
Discontinued Application: 70506

Drug Name

METOCLOPRAMIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

1989-06-22

70506 / 1

Active Ingredient

METOCLOPRAMIDE HYDROCHLORIDE

Application Number

70506

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

1989-06-22

Regulatory Status

Discontinued

1988
07 Nov
Discontinued Application: 70847

Drug Name

METOCLOPRAMIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

1988-11-07

70847 / 1

Active Ingredient

METOCLOPRAMIDE HYDROCHLORIDE

Application Number

70847

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

1988-11-07

Regulatory Status

Discontinued

1989
03 Mar
Discontinued Application: 71291

Drug Name

METOCLOPRAMIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

1989-03-03

71291 / 1

Active Ingredient

METOCLOPRAMIDE HYDROCHLORIDE

Application Number

71291

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

1989-03-03

Regulatory Status

Discontinued

1989
18 Jan
Discontinued Application: 71990

Drug Name

METOCLOPRAMIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

1989-01-18

71990 / 1

Active Ingredient

METOCLOPRAMIDE HYDROCHLORIDE

Application Number

71990

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

1989-01-18

Regulatory Status

Discontinued

1991
17 Jan
Discontinued Application: 73117

Drug Name

METOCLOPRAMIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

1991-01-17

73117 / 1

Active Ingredient

METOCLOPRAMIDE HYDROCHLORIDE

Application Number

73117

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

1991-01-17

Regulatory Status

Discontinued

1991
17 Jan
RX Application: 73118

Drug Name

METOCLOPRAMIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

1991-01-17

73118 / 1

Active Ingredient

METOCLOPRAMIDE HYDROCHLORIDE

Application Number

73118

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

1991-01-17

Regulatory Status

RX

1996
02 Aug
Discontinued Application: 74147

Drug Name

METOCLOPRAMIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

1996-08-02

74147 / 1

Active Ingredient

METOCLOPRAMIDE HYDROCHLORIDE

Application Number

74147

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

1996-08-02

Regulatory Status

Discontinued

1993
21 Dec
Discontinued Application: 74133

Drug Name

METOPROLOL TARTRATE

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

1993-12-21

74133 / 1

Active Ingredient

METOPROLOL TARTRATE

Application Number

74133

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

1993-12-21

Regulatory Status

Discontinued

1998
06 Jul
Discontinued Application: 75160

Drug Name

METOPROLOL TARTRATE

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

1998-07-06

75160 / 1

Active Ingredient

METOPROLOL TARTRATE

Application Number

75160

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

1998-07-06

Regulatory Status

Discontinued

2008
29 Apr
RX Application: 78085

Drug Name

METOPROLOL TARTRATE

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2008-04-29

78085 / 1

Active Ingredient

METOPROLOL TARTRATE

Application Number

78085

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2008-04-29

Regulatory Status

RX

1983
18 Nov
RX Application: 18890

Drug Name

METRONIDAZOLE IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

500MG/100ML

Approval Date

1983-11-18

18890 / 2

Active Ingredient

METRONIDAZOLE

Application Number

18890

Product Number

2

Dosage Form

-

Strength

500MG/100ML

Approval Date

1983-11-18

Regulatory Status

RX

2000
20 Jun
RX Application: 75293

Drug Name

MIDAZOLAM HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2000-06-20

75293 / 1

Active Ingredient

MIDAZOLAM HYDROCHLORIDE

Application Number

75293

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2000-06-20

Regulatory Status

RX

2000
20 Jun
RX Application: 75293

Drug Name

MIDAZOLAM HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

2000-06-20

75293 / 2

Active Ingredient

MIDAZOLAM HYDROCHLORIDE

Application Number

75293

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

2000-06-20

Regulatory Status

RX

2000
20 Jun
Discontinued Application: 75396

Drug Name

MIDAZOLAM HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2000-06-20

75396 / 1

Active Ingredient

MIDAZOLAM HYDROCHLORIDE

Application Number

75396

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2000-06-20

Regulatory Status

Discontinued

2000
20 Jun
Discontinued Application: 75396

Drug Name

MIDAZOLAM HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

2000-06-20

75396 / 2

Active Ingredient

MIDAZOLAM HYDROCHLORIDE

Application Number

75396

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

2000-06-20

Regulatory Status

Discontinued

2000
20 Jun
Discontinued Application: 75409

Drug Name

MIDAZOLAM HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

2000-06-20

75409 / 1

Active Ingredient

MIDAZOLAM HYDROCHLORIDE

Application Number

75409

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

2000-06-20

Regulatory Status

Discontinued

2000
20 Jun
Discontinued Application: 75409

Drug Name

MIDAZOLAM HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2000-06-20

75409 / 2

Active Ingredient

MIDAZOLAM HYDROCHLORIDE

Application Number

75409

Product Number

2

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2000-06-20

Regulatory Status

Discontinued

2000
20 Jun
Discontinued Application: 75484

Drug Name

MIDAZOLAM HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

2000-06-20

75484 / 1

Active Ingredient

MIDAZOLAM HYDROCHLORIDE

Application Number

75484

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

2000-06-20

Regulatory Status

Discontinued

2002
13 Jun
Discontinued Application: 75856

Drug Name

MIDAZOLAM HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2002-06-13

75856 / 1

Active Ingredient

MIDAZOLAM HYDROCHLORIDE

Application Number

75856

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2002-06-13

Regulatory Status

Discontinued

2002
13 Jun
Discontinued Application: 75856

Drug Name

MIDAZOLAM HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

2002-06-13

75856 / 2

Active Ingredient

MIDAZOLAM HYDROCHLORIDE

Application Number

75856

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

2002-06-13

Regulatory Status

Discontinued

2002
22 Jul
RX Application: 75857

Drug Name

MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2002-07-22

75857 / 1

Active Ingredient

MIDAZOLAM HYDROCHLORIDE

Application Number

75857

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2002-07-22

Regulatory Status

RX

2002
22 Jul
RX Application: 75857

Drug Name

MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

2002-07-22

75857 / 2

Active Ingredient

MIDAZOLAM HYDROCHLORIDE

Application Number

75857

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

2002-07-22

Regulatory Status

RX

2002
28 May
Discontinued Application: 75830

Drug Name

MILRINONE LACTATE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2002-05-28

75830 / 1

Active Ingredient

MILRINONE LACTATE

Application Number

75830

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2002-05-28

Regulatory Status

Discontinued

2002
28 May
Discontinued Application: 75884

Drug Name

MILRINONE LACTATE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2002-05-28

75884 / 1

Active Ingredient

MILRINONE LACTATE

Application Number

75884

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2002-05-28

Regulatory Status

Discontinued

2014
03 Sep
RX Application: 203280

Drug Name

MILRINONE LACTATE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2014-09-03

203280 / 1

Active Ingredient

MILRINONE LACTATE

Application Number

203280

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2014-09-03

Regulatory Status

RX

2002
28 May
Discontinued Application: 75885

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

75885 / 1

Active Ingredient

MILRINONE LACTATE

Application Number

75885

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2002-05-28

Regulatory Status

Discontinued

2002
28 May
Discontinued Application: 75885

Drug Name

MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

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

Approval Date

2002-05-28

75885 / 2

Active Ingredient

MILRINONE LACTATE

Application Number

75885

Product Number

2

Dosage Form

-

Strength

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

Approval Date

2002-05-28

Regulatory Status

Discontinued

1995
29 Nov
Discontinued Application: 64106

Drug Name

MITOMYCIN

Product Number

1

Dosage Form

-

Strength

20MG/VIAL

Approval Date

1995-11-29

64106 / 1

Active Ingredient

MITOMYCIN

Application Number

64106

Product Number

1

Dosage Form

-

Strength

20MG/VIAL

Approval Date

1995-11-29

Regulatory Status

Discontinued

2006
11 Apr
RX Application: 76871

Drug Name

MITOXANTRONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2006-04-11

76871 / 1

Active Ingredient

MITOXANTRONE HYDROCHLORIDE

Application Number

76871

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2006-04-11

Regulatory Status

RX

2006
11 Apr
RX Application: 76871

Drug Name

MITOXANTRONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

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

Approval Date

2006-04-11

76871 / 2

Active Ingredient

MITOXANTRONE HYDROCHLORIDE

Application Number

76871

Product Number

2

Dosage Form

-

Strength

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

Approval Date

2006-04-11

Regulatory Status

RX

2006
11 Apr
RX Application: 76871

Drug Name

MITOXANTRONE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

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

Approval Date

2006-04-11

76871 / 3

Active Ingredient

MITOXANTRONE HYDROCHLORIDE

Application Number

76871

Product Number

3

Dosage Form

-

Strength

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

Approval Date

2006-04-11

Regulatory Status

RX

1988
11 May
Discontinued Application: 71849

Drug Name

MORPHINE SULFATE

Product Number

1

Dosage Form

-

Strength

0.5MG/ML

Approval Date

1988-05-11

71849 / 1

Active Ingredient

MORPHINE SULFATE

Application Number

71849

Product Number

1

Dosage Form

-

Strength

0.5MG/ML

Approval Date

1988-05-11

Regulatory Status

Discontinued

1988
11 May
Discontinued Application: 71850

Drug Name

MORPHINE SULFATE

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

1988-05-11

71850 / 1

Active Ingredient

MORPHINE SULFATE

Application Number

71850

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

1988-05-11

Regulatory Status

Discontinued

1992
30 Sep
RX Application: 73509

Drug Name

MORPHINE SULFATE

Product Number

1

Dosage Form

-

Strength

0.5MG/ML

Approval Date

1992-09-30

73509 / 1

Active Ingredient

MORPHINE SULFATE

Application Number

73509

Product Number

1

Dosage Form

-

Strength

0.5MG/ML

Approval Date

1992-09-30

Regulatory Status

RX

1992
30 Sep
RX Application: 73510

Drug Name

MORPHINE SULFATE

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

1992-09-30

73510 / 1

Active Ingredient

MORPHINE SULFATE

Application Number

73510

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

1992-09-30

Regulatory Status

RX

2011
14 Nov
RX Application: 202515

Drug Name

MORPHINE SULFATE

Product Number

1

Dosage Form

-

Strength

2MG/ML

Approval Date

2011-11-14

202515 / 1

Active Ingredient

MORPHINE SULFATE

Application Number

202515

Product Number

1

Dosage Form

-

Strength

2MG/ML

Approval Date

2011-11-14

Regulatory Status

RX

2011
14 Nov
RX Application: 202515

Drug Name

MORPHINE SULFATE

Product Number

2

Dosage Form

-

Strength

4MG/ML

Approval Date

2011-11-14

202515 / 2

Active Ingredient

MORPHINE SULFATE

Application Number

202515

Product Number

2

Dosage Form

-

Strength

4MG/ML

Approval Date

2011-11-14

Regulatory Status

RX

2011
14 Nov
RX Application: 202515

Drug Name

MORPHINE SULFATE

Product Number

3

Dosage Form

-

Strength

8MG/ML

Approval Date

2011-11-14

202515 / 3

Active Ingredient

MORPHINE SULFATE

Application Number

202515

Product Number

3

Dosage Form

-

Strength

8MG/ML

Approval Date

2011-11-14

Regulatory Status

RX

2011
14 Nov
RX Application: 202515

Drug Name

MORPHINE SULFATE

Product Number

4

Dosage Form

-

Strength

10MG/ML

Approval Date

2011-11-14

202515 / 4

Active Ingredient

MORPHINE SULFATE

Application Number

202515

Product Number

4

Dosage Form

-

Strength

10MG/ML

Approval Date

2011-11-14

Regulatory Status

RX

2011
14 Nov
Discontinued Application: 202515

Drug Name

MORPHINE SULFATE

Product Number

5

Dosage Form

-

Strength

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

Approval Date

2011-11-14

202515 / 5

Active Ingredient

MORPHINE SULFATE

Application Number

202515

Product Number

5

Dosage Form

-

Strength

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

Approval Date

2011-11-14

Regulatory Status

Discontinued

2021
29 Apr
RX Application: 202515

Drug Name

MORPHINE SULFATE

Product Number

6

Dosage Form

-

Strength

50MG/ML

Approval Date

2021-04-29

202515 / 6

Active Ingredient

MORPHINE SULFATE

Application Number

202515

Product Number

6

Dosage Form

-

Strength

50MG/ML

Approval Date

2021-04-29

Regulatory Status

RX

1989
03 Feb
RX Application: 70914

Drug Name

NALBUPHINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG/ML (10MG/ML)

Approval Date

1989-02-03

70914 / 1

Active Ingredient

NALBUPHINE HYDROCHLORIDE

Application Number

70914

Product Number

1

Dosage Form

-

Strength

10MG/ML (10MG/ML)

Approval Date

1989-02-03

Regulatory Status

RX

1989
03 Feb
RX Application: 70915

Drug Name

NALBUPHINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG/10ML (10MG/ML)

Approval Date

1989-02-03

70915 / 1

Active Ingredient

NALBUPHINE HYDROCHLORIDE

Application Number

70915

Product Number

1

Dosage Form

-

Strength

100MG/10ML (10MG/ML)

Approval Date

1989-02-03

Regulatory Status

RX

1989
03 Feb
RX Application: 70916

Drug Name

NALBUPHINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

20MG/ML (20MG/ML)

Approval Date

1989-02-03

70916 / 1

Active Ingredient

NALBUPHINE HYDROCHLORIDE

Application Number

70916

Product Number

1

Dosage Form

-

Strength

20MG/ML (20MG/ML)

Approval Date

1989-02-03

Regulatory Status

RX

1989
03 Feb
RX Application: 70918

Drug Name

NALBUPHINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

200MG/10ML (20MG/ML)

Approval Date

1989-02-03

70918 / 1

Active Ingredient

NALBUPHINE HYDROCHLORIDE

Application Number

70918

Product Number

1

Dosage Form

-

Strength

200MG/10ML (20MG/ML)

Approval Date

1989-02-03

Regulatory Status

RX

1986
24 Sep
Discontinued Application: 70171

Drug Name

NALOXONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.02MG/ML

Approval Date

1986-09-24

70171 / 1

Active Ingredient

NALOXONE HYDROCHLORIDE

Application Number

70171

Product Number

1

Dosage Form

-

Strength

0.02MG/ML

Approval Date

1986-09-24

Regulatory Status

Discontinued

1986
24 Sep
RX Application: 70172

Drug Name

NALOXONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.4MG/ML

Approval Date

1986-09-24

70172 / 1

Active Ingredient

NALOXONE HYDROCHLORIDE

Application Number

70172

Product Number

1

Dosage Form

-

Strength

0.4MG/ML

Approval Date

1986-09-24

Regulatory Status

RX

1987
16 Jan
Discontinued Application: 70252

Drug Name

NALOXONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.02MG/ML

Approval Date

1987-01-16

70252 / 1

Active Ingredient

NALOXONE HYDROCHLORIDE

Application Number

70252

Product Number

1

Dosage Form

-

Strength

0.02MG/ML

Approval Date

1987-01-16

Regulatory Status

Discontinued

1987
16 Jan
Discontinued Application: 70253

Drug Name

NALOXONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.02MG/ML

Approval Date

1987-01-16

70253 / 1

Active Ingredient

NALOXONE HYDROCHLORIDE

Application Number

70253

Product Number

1

Dosage Form

-

Strength

0.02MG/ML

Approval Date

1987-01-16

Regulatory Status

Discontinued

1987
07 Jan
Discontinued Application: 70254

Drug Name

NALOXONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.4MG/ML

Approval Date

1987-01-07

70254 / 1

Active Ingredient

NALOXONE HYDROCHLORIDE

Application Number

70254

Product Number

1

Dosage Form

-

Strength

0.4MG/ML

Approval Date

1987-01-07

Regulatory Status

Discontinued

1987
07 Jan
Discontinued Application: 70255

Drug Name

NALOXONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.4MG/ML

Approval Date

1987-01-07

70255 / 1

Active Ingredient

NALOXONE HYDROCHLORIDE

Application Number

70255

Product Number

1

Dosage Form

-

Strength

0.4MG/ML

Approval Date

1987-01-07

Regulatory Status

Discontinued

1987
07 Jan
RX Application: 70256

Drug Name

NALOXONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.4MG/ML

Approval Date

1987-01-07

70256 / 1

Active Ingredient

NALOXONE HYDROCHLORIDE

Application Number

70256

Product Number

1

Dosage Form

-

Strength

0.4MG/ML

Approval Date

1987-01-07

Regulatory Status

RX

1987
07 Jan
RX Application: 70257

Drug Name

NALOXONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.4MG/ML

Approval Date

1987-01-07

70257 / 1

Active Ingredient

NALOXONE HYDROCHLORIDE

Application Number

70257

Product Number

1

Dosage Form

-

Strength

0.4MG/ML

Approval Date

1987-01-07

Regulatory Status

RX

1984
17 Jan
Discontinued Application: 18792

Drug Name

NEOPHAM 6.4%

Product Number

1

Dosage Form

-

Strength

6.4% (6.4GM/100ML)

Approval Date

1984-01-17

18792 / 1

Active Ingredient

AMINO ACIDS

Application Number

18792

Product Number

1

Dosage Form

-

Strength

6.4% (6.4GM/100ML)

Approval Date

1984-01-17

Regulatory Status

Discontinued

1991
11 Oct
RX Application: 20122

Drug Name

NIPENT

Product Number

1

Dosage Form

-

Strength

10MG/VIAL

Approval Date

1991-10-11

20122 / 1

Active Ingredient

PENTOSTATIN

Application Number

20122

Product Number

1

Dosage Form

-

Strength

10MG/VIAL

Approval Date

1991-10-11

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 18531

Drug Name

NITROGLYCERIN

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

18531 / 1

Active Ingredient

NITROGLYCERIN

Application Number

18531

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

Regulatory Status

Discontinued

1990
31 Aug
Discontinued Application: 71846

Drug Name

NITROGLYCERIN IN DEXTROSE 5%

Product Number

1

Dosage Form

-

Strength

10MG/100ML

Approval Date

1990-08-31

71846 / 1

Active Ingredient

NITROGLYCERIN

Application Number

71846

Product Number

1

Dosage Form

-

Strength

10MG/100ML

Approval Date

1990-08-31

Regulatory Status

Discontinued

1990
31 Aug
Discontinued Application: 71847

Drug Name

NITROGLYCERIN IN DEXTROSE 5%

Product Number

1

Dosage Form

-

Strength

20MG/100ML

Approval Date

1990-08-31

71847 / 1

Active Ingredient

NITROGLYCERIN

Application Number

71847

Product Number

1

Dosage Form

-

Strength

20MG/100ML

Approval Date

1990-08-31

Regulatory Status

Discontinued

1990
31 Aug
Discontinued Application: 71848

Drug Name

NITROGLYCERIN IN DEXTROSE 5%

Product Number

1

Dosage Form

-

Strength

40MG/100ML

Approval Date

1990-08-31

71848 / 1

Active Ingredient

NITROGLYCERIN

Application Number

71848

Product Number

1

Dosage Form

-

Strength

40MG/100ML

Approval Date

1990-08-31

Regulatory Status

Discontinued

1994
26 Oct
Discontinued Application: 74083

Drug Name

NITROGLYCERIN IN DEXTROSE 5%

Product Number

1

Dosage Form

-

Strength

0.1MG/ML

Approval Date

1994-10-26

74083 / 1

Active Ingredient

NITROGLYCERIN

Application Number

74083

Product Number

1

Dosage Form

-

Strength

0.1MG/ML

Approval Date

1994-10-26

Regulatory Status

Discontinued

1986
09 Jun
Discontinued Application: 70566

Drug Name

NITROPRESS

Product Number

1

Dosage Form

-

Strength

50MG/VIAL

Approval Date

1986-06-09

70566 / 1

Active Ingredient

SODIUM NITROPRUSSIDE

Application Number

70566

Product Number

1

Dosage Form

-

Strength

50MG/VIAL

Approval Date

1986-06-09

Regulatory Status

Discontinued

-
Unclassified Application: 761080

Drug Name

NIVESTYM

Product Number

1

Dosage Form

-

Strength

300MCG/ML

Approval Date

-

761080 / 1

Active Ingredient

FILGRASTIM-AAFI

Application Number

761080

Product Number

1

Dosage Form

-

Strength

300MCG/ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 761080

Drug Name

NIVESTYM

Product Number

2

Dosage Form

-

Strength

480MCG/1.6ML

Approval Date

-

761080 / 2

Active Ingredient

FILGRASTIM-AAFI

Application Number

761080

Product Number

2

Dosage Form

-

Strength

480MCG/1.6ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 761080

Drug Name

NIVESTYM

Product Number

3

Dosage Form

-

Strength

300MCG/0.5ML

Approval Date

-

761080 / 3

Active Ingredient

FILGRASTIM-AAFI

Application Number

761080

Product Number

3

Dosage Form

-

Strength

300MCG/0.5ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 761080

Drug Name

NIVESTYM

Product Number

4

Dosage Form

-

Strength

480MCG/0.8ML

Approval Date

-

761080 / 4

Active Ingredient

FILGRASTIM-AAFI

Application Number

761080

Product Number

4

Dosage Form

-

Strength

480MCG/0.8ML

Approval Date

-

Regulatory Status

Unclassified

1982
09 Aug
Discontinued Application: 17957

Drug Name

NOVAMINE 11.4%

Product Number

3

Dosage Form

-

Strength

11.4% (11.4GM/100ML)

Approval Date

1982-08-09

17957 / 3

Active Ingredient

AMINO ACIDS

Application Number

17957

Product Number

3

Dosage Form

-

Strength

11.4% (11.4GM/100ML)

Approval Date

1982-08-09

Regulatory Status

Discontinued

1986
28 Nov
Discontinued Application: 17957

Drug Name

NOVAMINE 15%

Product Number

4

Dosage Form

-

Strength

15% (75GM/500ML)

Approval Date

1986-11-28

17957 / 4

Active Ingredient

AMINO ACIDS

Application Number

17957

Product Number

4

Dosage Form

-

Strength

15% (75GM/500ML)

Approval Date

1986-11-28

Regulatory Status

Discontinued

1982
09 Aug
Discontinued Application: 17957

Drug Name

NOVAMINE 8.5%

Product Number

2

Dosage Form

-

Strength

8.5% (8.5GM/100ML)

Approval Date

1982-08-09

17957 / 2

Active Ingredient

AMINO ACIDS

Application Number

17957

Product Number

2

Dosage Form

-

Strength

8.5% (8.5GM/100ML)

Approval Date

1982-08-09

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85362

Drug Name

NOVOCAIN

Product Number

3

Dosage Form

-

Strength

1%

Approval Date

1982-01-01

85362 / 3

Active Ingredient

PROCAINE HYDROCHLORIDE

Application Number

85362

Product Number

3

Dosage Form

-

Strength

1%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85362

Drug Name

NOVOCAIN

Product Number

4

Dosage Form

-

Strength

2%

Approval Date

1982-01-01

85362 / 4

Active Ingredient

PROCAINE HYDROCHLORIDE

Application Number

85362

Product Number

4

Dosage Form

-

Strength

2%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 86797

Drug Name

NOVOCAIN

Product Number

1

Dosage Form

-

Strength

10%

Approval Date

1982-01-01

86797 / 1

Active Ingredient

PROCAINE HYDROCHLORIDE

Application Number

86797

Product Number

1

Dosage Form

-

Strength

10%

Approval Date

1982-01-01

Regulatory Status

Discontinued

-
Unclassified Application: 761111

Drug Name

NYVEPRIA

Product Number

1

Dosage Form

-

Strength

6MG/0.6ML

Approval Date

-

761111 / 1

Active Ingredient

PEGFILGRASTIM-APGF

Application Number

761111

Product Number

1

Dosage Form

-

Strength

6MG/0.6ML

Approval Date

-

Regulatory Status

Unclassified

1986
30 Apr
Discontinued Application: 19284

Drug Name

OCL

Product Number

1

Dosage Form

-

Strength

6GM/100ML;75MG/100ML;168MG/100ML;146MG/100ML;1.29GM/100ML

Approval Date

1986-04-30

19284 / 1

Active Ingredient

POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE

Application Number

19284

Product Number

1

Dosage Form

-

Strength

6GM/100ML;75MG/100ML;168MG/100ML;146MG/100ML;1.29GM/100ML

Approval Date

1986-04-30

Regulatory Status

Discontinued

2006
26 Dec
Discontinued Application: 76695

Drug Name

ONDANSETRON HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2006-12-26

76695 / 1

Active Ingredient

ONDANSETRON HYDROCHLORIDE

Application Number

76695

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2006-12-26

Regulatory Status

Discontinued

2006
26 Dec
RX Application: 77473

Drug Name

ONDANSETRON HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2006-12-26

77473 / 1

Active Ingredient

ONDANSETRON HYDROCHLORIDE

Application Number

77473

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2006-12-26

Regulatory Status

RX

2007
19 Jan
Discontinued Application: 77840

Drug Name

ONDANSETRON HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2007-01-19

77840 / 1

Active Ingredient

ONDANSETRON HYDROCHLORIDE

Application Number

77840

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2007-01-19

Regulatory Status

Discontinued

2007
26 Feb
Discontinued Application: 76978

Drug Name

ONDANSETRON HYDROCHLORIDE AND DEXTROSE IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

EQ 0.64MG BASE/ML

Approval Date

2007-02-26

76978 / 1

Active Ingredient

ONDANSETRON HYDROCHLORIDE

Application Number

76978

Product Number

1

Dosage Form

-

Strength

EQ 0.64MG BASE/ML

Approval Date

2007-02-26

Regulatory Status

Discontinued

2006
26 Dec
Discontinued Application: 76696

Drug Name

ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2006-12-26

76696 / 1

Active Ingredient

ONDANSETRON HYDROCHLORIDE

Application Number

76696

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2006-12-26

Regulatory Status

Discontinued

2006
26 Dec
RX Application: 77548

Drug Name

ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2006-12-26

77548 / 1

Active Ingredient

ONDANSETRON HYDROCHLORIDE

Application Number

77548

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2006-12-26

Regulatory Status

RX

2015
11 Dec
Discontinued Application: 203950

Drug Name

OXACILLIN SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2015-12-11

203950 / 1

Active Ingredient

OXACILLIN SODIUM

Application Number

203950

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2015-12-11

Regulatory Status

Discontinued

2015
11 Dec
Discontinued Application: 203950

Drug Name

OXACILLIN SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

2015-12-11

203950 / 2

Active Ingredient

OXACILLIN SODIUM

Application Number

203950

Product Number

2

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

2015-12-11

Regulatory Status

Discontinued

2009
07 Aug
RX Application: 78813

Drug Name

OXALIPLATIN

Product Number

1

Dosage Form

-

Strength

50MG/10ML (5MG/ML)

Approval Date

2009-08-07

78813 / 1

Active Ingredient

OXALIPLATIN

Application Number

78813

Product Number

1

Dosage Form

-

Strength

50MG/10ML (5MG/ML)

Approval Date

2009-08-07

Regulatory Status

RX

2009
07 Aug
RX Application: 78813

Drug Name

OXALIPLATIN

Product Number

2

Dosage Form

-

Strength

100MG/20ML (5MG/ML)

Approval Date

2009-08-07

78813 / 2

Active Ingredient

OXALIPLATIN

Application Number

78813

Product Number

2

Dosage Form

-

Strength

100MG/20ML (5MG/ML)

Approval Date

2009-08-07

Regulatory Status

RX

2009
30 Sep
Discontinued Application: 78815

Drug Name

OXALIPLATIN

Product Number

1

Dosage Form

-

Strength

50MG/VIAL

Approval Date

2009-09-30

78815 / 1

Active Ingredient

OXALIPLATIN

Application Number

78815

Product Number

1

Dosage Form

-

Strength

50MG/VIAL

Approval Date

2009-09-30

Regulatory Status

Discontinued

2009
30 Sep
Discontinued Application: 78815

Drug Name

OXALIPLATIN

Product Number

2

Dosage Form

-

Strength

100MG/VIAL

Approval Date

2009-09-30

78815 / 2

Active Ingredient

OXALIPLATIN

Application Number

78815

Product Number

2

Dosage Form

-

Strength

100MG/VIAL

Approval Date

2009-09-30

Regulatory Status

Discontinued

2002
08 May
RX Application: 76131

Drug Name

PACLITAXEL

Product Number

1

Dosage Form

-

Strength

6MG/ML

Approval Date

2002-05-08

76131 / 1

Active Ingredient

PACLITAXEL

Application Number

76131

Product Number

1

Dosage Form

-

Strength

6MG/ML

Approval Date

2002-05-08

Regulatory Status

RX

2002
01 Aug
Discontinued Application: 76233

Drug Name

PACLITAXEL

Product Number

1

Dosage Form

-

Strength

6MG/ML

Approval Date

2002-08-01

76233 / 1

Active Ingredient

PACLITAXEL

Application Number

76233

Product Number

1

Dosage Form

-

Strength

6MG/ML

Approval Date

2002-08-01

Regulatory Status

Discontinued

2018
19 Sep
RX Application: 207005

Drug Name

PALONOSETRON HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)

Approval Date

2018-09-19

207005 / 1

Active Ingredient

PALONOSETRON HYDROCHLORIDE

Application Number

207005

Product Number

1

Dosage Form

-

Strength

EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)

Approval Date

2018-09-19

Regulatory Status

RX

2018
19 Sep
Discontinued Application: 207005

Drug Name

PALONOSETRON HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)

Approval Date

2018-09-19

207005 / 2

Active Ingredient

PALONOSETRON HYDROCHLORIDE

Application Number

207005

Product Number

2

Dosage Form

-

Strength

EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)

Approval Date

2018-09-19

Regulatory Status

Discontinued

2002
27 Jun
RX Application: 75841

Drug Name

PAMIDRONATE DISODIUM

Product Number

1

Dosage Form

-

Strength

30MG/10ML (3MG/ML)

Approval Date

2002-06-27

75841 / 1

Active Ingredient

PAMIDRONATE DISODIUM

Application Number

75841

Product Number

1

Dosage Form

-

Strength

30MG/10ML (3MG/ML)

Approval Date

2002-06-27

Regulatory Status

RX

2002
27 Jun
RX Application: 75841

Drug Name

PAMIDRONATE DISODIUM

Product Number

2

Dosage Form

-

Strength

60MG/10ML (6MG/ML)

Approval Date

2002-06-27

75841 / 2

Active Ingredient

PAMIDRONATE DISODIUM

Application Number

75841

Product Number

2

Dosage Form

-

Strength

60MG/10ML (6MG/ML)

Approval Date

2002-06-27

Regulatory Status

RX

2002
27 Jun
RX Application: 75841

Drug Name

PAMIDRONATE DISODIUM

Product Number

3

Dosage Form

-

Strength

90MG/10ML (9MG/ML)

Approval Date

2002-06-27

75841 / 3

Active Ingredient

PAMIDRONATE DISODIUM

Application Number

75841

Product Number

3

Dosage Form

-

Strength

90MG/10ML (9MG/ML)

Approval Date

2002-06-27

Regulatory Status

RX

1989
19 Jan
Discontinued Application: 72320

Drug Name

PANCURONIUM BROMIDE

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

1989-01-19

72320 / 1

Active Ingredient

PANCURONIUM BROMIDE

Application Number

72320

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

1989-01-19

Regulatory Status

Discontinued

1989
19 Jan
Discontinued Application: 72321

Drug Name

PANCURONIUM BROMIDE

Product Number

1

Dosage Form

-

Strength

2MG/ML

Approval Date

1989-01-19

72321 / 1

Active Ingredient

PANCURONIUM BROMIDE

Application Number

72321

Product Number

1

Dosage Form

-

Strength

2MG/ML

Approval Date

1989-01-19

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 5264

Drug Name

PANHEPRIN

Product Number

4

Dosage Form

-

Strength

1,000 UNITS/ML

Approval Date

1982-01-01

5264 / 4

Active Ingredient

HEPARIN SODIUM

Application Number

5264

Product Number

4

Dosage Form

-

Strength

1,000 UNITS/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 5264

Drug Name

PANHEPRIN

Product Number

6

Dosage Form

-

Strength

5,000 UNITS/ML

Approval Date

1982-01-01

5264 / 6

Active Ingredient

HEPARIN SODIUM

Application Number

5264

Product Number

6

Dosage Form

-

Strength

5,000 UNITS/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 5264

Drug Name

PANHEPRIN

Product Number

7

Dosage Form

-

Strength

10,000 UNITS/ML

Approval Date

1982-01-01

5264 / 7

Active Ingredient

HEPARIN SODIUM

Application Number

5264

Product Number

7

Dosage Form

-

Strength

10,000 UNITS/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 5264

Drug Name

PANHEPRIN

Product Number

8

Dosage Form

-

Strength

20,000 UNITS/ML

Approval Date

1982-01-01

5264 / 8

Active Ingredient

HEPARIN SODIUM

Application Number

5264

Product Number

8

Dosage Form

-

Strength

20,000 UNITS/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 5264

Drug Name

PANHEPRIN

Product Number

9

Dosage Form

-

Strength

40,000 UNITS/ML

Approval Date

1982-01-01

5264 / 9

Active Ingredient

HEPARIN SODIUM

Application Number

5264

Product Number

9

Dosage Form

-

Strength

40,000 UNITS/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

2014
21 Oct
Discontinued Application: 201657

Drug Name

PARICALCITOL

Product Number

1

Dosage Form

-

Strength

0.002MG/ML (0.002MG/ML)

Approval Date

2014-10-21

201657 / 1

Active Ingredient

PARICALCITOL

Application Number

201657

Product Number

1

Dosage Form

-

Strength

0.002MG/ML (0.002MG/ML)

Approval Date

2014-10-21

Regulatory Status

Discontinued

2014
21 Oct
Discontinued Application: 201657

Drug Name

PARICALCITOL

Product Number

2

Dosage Form

-

Strength

0.005MG/ML (0.005MG/ML)

Approval Date

2014-10-21

201657 / 2

Active Ingredient

PARICALCITOL

Application Number

201657

Product Number

2

Dosage Form

-

Strength

0.005MG/ML (0.005MG/ML)

Approval Date

2014-10-21

Regulatory Status

Discontinued

2014
21 Oct
Discontinued Application: 201657

Drug Name

PARICALCITOL

Product Number

3

Dosage Form

-

Strength

0.01MG/2ML (0.005MG/ML)

Approval Date

2014-10-21

201657 / 3

Active Ingredient

PARICALCITOL

Application Number

201657

Product Number

3

Dosage Form

-

Strength

0.01MG/2ML (0.005MG/ML)

Approval Date

2014-10-21

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85995

Drug Name

PEDIATRIC LTA KIT

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1982-01-01

85995 / 1

Active Ingredient

LIDOCAINE HYDROCHLORIDE

Application Number

85995

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1982-01-01

Regulatory Status

Discontinued

2022
25 May
Discontinued Application: 202111

Drug Name

PEMETREXED DISODIUM

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE/VIAL

Approval Date

2022-05-25

202111 / 1

Active Ingredient

PEMETREXED DISODIUM

Application Number

202111

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE/VIAL

Approval Date

2022-05-25

Regulatory Status

Discontinued

2022
25 May
Discontinued Application: 202111

Drug Name

PEMETREXED DISODIUM

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2022-05-25

202111 / 2

Active Ingredient

PEMETREXED DISODIUM

Application Number

202111

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2022-05-25

Regulatory Status

Discontinued

2022
25 May
Discontinued Application: 202111

Drug Name

PEMETREXED DISODIUM

Product Number

3

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2022-05-25

202111 / 3

Active Ingredient

PEMETREXED DISODIUM

Application Number

202111

Product Number

3

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2022-05-25

Regulatory Status

Discontinued

2022
22 Jun
RX Application: 214218

Drug Name

PEMETREXED DISODIUM

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2022-06-22

214218 / 1

Active Ingredient

PEMETREXED DISODIUM

Application Number

214218

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2022-06-22

Regulatory Status

RX

2022
22 Jun
RX Application: 214218

Drug Name

PEMETREXED DISODIUM

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/20ML (EQ 25MG BASE/ML)

Approval Date

2022-06-22

214218 / 2

Active Ingredient

PEMETREXED DISODIUM

Application Number

214218

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/20ML (EQ 25MG BASE/ML)

Approval Date

2022-06-22

Regulatory Status

RX

2022
22 Jun
RX Application: 214218

Drug Name

PEMETREXED DISODIUM

Product Number

3

Dosage Form

-

Strength

EQ 1GM BASE/40ML (EQ 25MG BASE/ML)

Approval Date

2022-06-22

214218 / 3

Active Ingredient

PEMETREXED DISODIUM

Application Number

214218

Product Number

3

Dosage Form

-

Strength

EQ 1GM BASE/40ML (EQ 25MG BASE/ML)

Approval Date

2022-06-22

Regulatory Status

RX

2022
10 Jun
Discontinued Application: 208746

Drug Name

PEMETREXED DITROMETHAMINE

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE/VIAL

Approval Date

2022-06-10

208746 / 1

Active Ingredient

PEMETREXED DITROMETHAMINE

Application Number

208746

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE/VIAL

Approval Date

2022-06-10

Regulatory Status

Discontinued

2022
10 Jun
Discontinued Application: 208746

Drug Name

PEMETREXED DITROMETHAMINE

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2022-06-10

208746 / 2

Active Ingredient

PEMETREXED DITROMETHAMINE

Application Number

208746

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2022-06-10

Regulatory Status

Discontinued

2022
10 Jun
Discontinued Application: 208746

Drug Name

PEMETREXED DITROMETHAMINE

Product Number

3

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2022-06-10

208746 / 3

Active Ingredient

PEMETREXED DITROMETHAMINE

Application Number

208746

Product Number

3

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2022-06-10

Regulatory Status

Discontinued

1992
30 Jun
Discontinued Application: 73479

Drug Name

PENTAMIDINE ISETHIONATE

Product Number

1

Dosage Form

-

Strength

300MG/VIAL

Approval Date

1992-06-30

73479 / 1

Active Ingredient

PENTAMIDINE ISETHIONATE

Application Number

73479

Product Number

1

Dosage Form

-

Strength

300MG/VIAL

Approval Date

1992-06-30

Regulatory Status

Discontinued

1987
17 Mar
Discontinued Application: 89521

Drug Name

PHENYTOIN SODIUM

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

1987-03-17

89521 / 1

Active Ingredient

PHENYTOIN SODIUM

Application Number

89521

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

1987-03-17

Regulatory Status

Discontinued

1987
18 Dec
Discontinued Application: 89744

Drug Name

PHENYTOIN SODIUM

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

1987-12-18

89744 / 1

Active Ingredient

PHENYTOIN SODIUM

Application Number

89744

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

1987-12-18

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 18406

Drug Name

PHYSIOSOL IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

14MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100ML

Approval Date

1982-01-01

18406 / 1

Active Ingredient

MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE

Application Number

18406

Product Number

1

Dosage Form

-

Strength

14MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
08 Jul
Discontinued Application: 18406

Drug Name

PHYSIOSOL PH 7.4 IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100ML

Approval Date

1982-07-08

18406 / 2

Active Ingredient

MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE

Application Number

18406

Product Number

2

Dosage Form

-

Strength

30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100ML

Approval Date

1982-07-08

Regulatory Status

Discontinued

2009
15 Sep
Discontinued Application: 65386

Drug Name

PIPERACILLIN AND TAZOBACTAM

Product Number

1

Dosage Form

-

Strength

EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL

Approval Date

2009-09-15

65386 / 1

Active Ingredient

PIPERACILLIN SODIUM; TAZOBACTAM SODIUM

Application Number

65386

Product Number

1

Dosage Form

-

Strength

EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL

Approval Date

2009-09-15

Regulatory Status

Discontinued

2009
15 Sep
Discontinued Application: 65386

Drug Name

PIPERACILLIN AND TAZOBACTAM

Product Number

2

Dosage Form

-

Strength

EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL

Approval Date

2009-09-15

65386 / 2

Active Ingredient

PIPERACILLIN SODIUM; TAZOBACTAM SODIUM

Application Number

65386

Product Number

2

Dosage Form

-

Strength

EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL

Approval Date

2009-09-15

Regulatory Status

Discontinued

2009
15 Sep
Discontinued Application: 65386

Drug Name

PIPERACILLIN AND TAZOBACTAM

Product Number

3

Dosage Form

-

Strength

EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL

Approval Date

2009-09-15

65386 / 3

Active Ingredient

PIPERACILLIN SODIUM; TAZOBACTAM SODIUM

Application Number

65386

Product Number

3

Dosage Form

-

Strength

EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL

Approval Date

2009-09-15

Regulatory Status

Discontinued

2009
15 Sep
Discontinued Application: 65446

Drug Name

PIPERACILLIN AND TAZOBACTAM

Product Number

1

Dosage Form

-

Strength

EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL

Approval Date

2009-09-15

65446 / 1

Active Ingredient

PIPERACILLIN SODIUM; TAZOBACTAM SODIUM

Application Number

65446

Product Number

1

Dosage Form

-

Strength

EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL

Approval Date

2009-09-15

Regulatory Status

Discontinued

1982
26 Feb
RX Application: 18608

Drug Name

PLEGISOL IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

17.6MG/100ML;325.3MG/100ML;119.3MG/100ML;643MG/100ML

Approval Date

1982-02-26

18608 / 1

Active Ingredient

CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

Application Number

18608

Product Number

1

Dosage Form

-

Strength

17.6MG/100ML;325.3MG/100ML;119.3MG/100ML;643MG/100ML

Approval Date

1982-02-26

Regulatory Status

RX

1984
20 Jul
RX Application: 18896

Drug Name

POTASSIUM ACETATE

Product Number

1

Dosage Form

-

Strength

2MEQ/ML

Approval Date

1984-07-20

18896 / 1

Active Ingredient

POTASSIUM ACETATE

Application Number

18896

Product Number

1

Dosage Form

-

Strength

2MEQ/ML

Approval Date

1984-07-20

Regulatory Status

RX

1982
01 Jan
RX Application: 80205

Drug Name

POTASSIUM CHLORIDE

Product Number

1

Dosage Form

-

Strength

2MEQ/ML

Approval Date

1982-01-01

80205 / 1

Active Ingredient

POTASSIUM CHLORIDE

Application Number

80205

Product Number

1

Dosage Form

-

Strength

2MEQ/ML

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 80205

Drug Name

POTASSIUM CHLORIDE

Product Number

3

Dosage Form

-

Strength

1MEQ/ML

Approval Date

1982-01-01

80205 / 3

Active Ingredient

POTASSIUM CHLORIDE

Application Number

80205

Product Number

3

Dosage Form

-

Strength

1MEQ/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 80205

Drug Name

POTASSIUM CHLORIDE

Product Number

4

Dosage Form

-

Strength

2.4MEQ/ML

Approval Date

1982-01-01

80205 / 4

Active Ingredient

POTASSIUM CHLORIDE

Application Number

80205

Product Number

4

Dosage Form

-

Strength

2.4MEQ/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 80205

Drug Name

POTASSIUM CHLORIDE

Product Number

5

Dosage Form

-

Strength

3.2MEQ/ML

Approval Date

1982-01-01

80205 / 5

Active Ingredient

POTASSIUM CHLORIDE

Application Number

80205

Product Number

5

Dosage Form

-

Strength

3.2MEQ/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83345

Drug Name

POTASSIUM CHLORIDE

Product Number

1

Dosage Form

-

Strength

1.5MEQ/ML

Approval Date

1982-01-01

83345 / 1

Active Ingredient

POTASSIUM CHLORIDE

Application Number

83345

Product Number

1

Dosage Form

-

Strength

1.5MEQ/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83345

Drug Name

POTASSIUM CHLORIDE

Product Number

2

Dosage Form

-

Strength

2MEQ/ML

Approval Date

1982-01-01

83345 / 2

Active Ingredient

POTASSIUM CHLORIDE

Application Number

83345

Product Number

2

Dosage Form

-

Strength

2MEQ/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83345

Drug Name

POTASSIUM CHLORIDE

Product Number

3

Dosage Form

-

Strength

1MEQ/ML

Approval Date

1982-01-01

83345 / 3

Active Ingredient

POTASSIUM CHLORIDE

Application Number

83345

Product Number

3

Dosage Form

-

Strength

1MEQ/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

2025
11 Sep
RX Application: 217459

Drug Name

POTASSIUM PHOSPHATES

Product Number

1

Dosage Form

-

Strength

3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)

Approval Date

2025-09-11

217459 / 1

Active Ingredient

POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC

Application Number

217459

Product Number

1

Dosage Form

-

Strength

3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)

Approval Date

2025-09-11

Regulatory Status

RX

1999
17 Dec
RX Application: 21038

Drug Name

PRECEDEX

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1999-12-17

21038 / 1

Active Ingredient

DEXMEDETOMIDINE HYDROCHLORIDE

Application Number

21038

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1999-12-17

Regulatory Status

RX

2013
13 Mar
RX Application: 21038

Drug Name

PRECEDEX

Product Number

2

Dosage Form

-

Strength

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

Approval Date

2013-03-13

21038 / 2

Active Ingredient

DEXMEDETOMIDINE HYDROCHLORIDE

Application Number

21038

Product Number

2

Dosage Form

-

Strength

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

Approval Date

2013-03-13

Regulatory Status

RX

2013
13 Mar
RX Application: 21038

Drug Name

PRECEDEX

Product Number

3

Dosage Form

-

Strength

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

Approval Date

2013-03-13

21038 / 3

Active Ingredient

DEXMEDETOMIDINE HYDROCHLORIDE

Application Number

21038

Product Number

3

Dosage Form

-

Strength

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

Approval Date

2013-03-13

Regulatory Status

RX

2014
14 Nov
RX Application: 21038

Drug Name

PRECEDEX

Product Number

4

Dosage Form

-

Strength

EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)

Approval Date

2014-11-14

21038 / 4

Active Ingredient

DEXMEDETOMIDINE HYDROCHLORIDE

Application Number

21038

Product Number

4

Dosage Form

-

Strength

EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)

Approval Date

2014-11-14

Regulatory Status

RX

2020
31 Jan
RX Application: 21038

Drug Name

PRECEDEX

Product Number

5

Dosage Form

-

Strength

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

Approval Date

2020-01-31

21038 / 5

Active Ingredient

DEXMEDETOMIDINE HYDROCHLORIDE

Application Number

21038

Product Number

5

Dosage Form

-

Strength

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

Approval Date

2020-01-31

Regulatory Status

RX

1986
12 Feb
RX Application: 89069

Drug Name

PROCAINAMIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

1986-02-12

89069 / 1

Active Ingredient

PROCAINAMIDE HYDROCHLORIDE

Application Number

89069

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

1986-02-12

Regulatory Status

RX

1986
12 Feb
Discontinued Application: 89070

Drug Name

PROCAINAMIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

500MG/ML

Approval Date

1986-02-12

89070 / 1

Active Ingredient

PROCAINAMIDE HYDROCHLORIDE

Application Number

89070

Product Number

1

Dosage Form

-

Strength

500MG/ML

Approval Date

1986-02-12

Regulatory Status

Discontinued

1987
25 Aug
Discontinued Application: 89537

Drug Name

PROCAINAMIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

500MG/ML

Approval Date

1987-08-25

89537 / 1

Active Ingredient

PROCAINAMIDE HYDROCHLORIDE

Application Number

89537

Product Number

1

Dosage Form

-

Strength

500MG/ML

Approval Date

1987-08-25

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 80416

Drug Name

PROCAINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1982-01-01

80416 / 1

Active Ingredient

PROCAINE HYDROCHLORIDE

Application Number

80416

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 80416

Drug Name

PROCAINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

2%

Approval Date

1982-01-01

80416 / 2

Active Ingredient

PROCAINE HYDROCHLORIDE

Application Number

80416

Product Number

2

Dosage Form

-

Strength

2%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1988
07 Apr
Discontinued Application: 89703

Drug Name

PROCHLORPERAZINE EDISYLATE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

1988-04-07

89703 / 1

Active Ingredient

PROCHLORPERAZINE EDISYLATE

Application Number

89703

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

1988-04-07

Regulatory Status

Discontinued

2000
08 Jun
Discontinued Application: 40372

Drug Name

PROMETHAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG/ML

Approval Date

2000-06-08

40372 / 1

Active Ingredient

PROMETHAZINE HYDROCHLORIDE

Application Number

40372

Product Number

1

Dosage Form

-

Strength

25MG/ML

Approval Date

2000-06-08

Regulatory Status

Discontinued

2000
08 Jun
Discontinued Application: 40372

Drug Name

PROMETHAZINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

50MG/ML

Approval Date

2000-06-08

40372 / 2

Active Ingredient

PROMETHAZINE HYDROCHLORIDE

Application Number

40372

Product Number

2

Dosage Form

-

Strength

50MG/ML

Approval Date

2000-06-08

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83838

Drug Name

PROMETHAZINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

50MG/ML

Approval Date

1982-01-01

83838 / 2

Active Ingredient

PROMETHAZINE HYDROCHLORIDE

Application Number

83838

Product Number

2

Dosage Form

-

Strength

50MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

2006
17 Mar
RX Application: 77908

Drug Name

PROPOFOL

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2006-03-17

77908 / 1

Active Ingredient

PROPOFOL

Application Number

77908

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2006-03-17

Regulatory Status

RX

1982
01 Jan
RX Application: 8845

Drug Name

QUELICIN

Product Number

6

Dosage Form

-

Strength

20MG/ML

Approval Date

1982-01-01

8845 / 6

Active Ingredient

SUCCINYLCHOLINE CHLORIDE

Application Number

8845

Product Number

6

Dosage Form

-

Strength

20MG/ML

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 8845

Drug Name

QUELICIN PRESERVATIVE FREE

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

8845 / 1

Active Ingredient

SUCCINYLCHOLINE CHLORIDE

Application Number

8845

Product Number

1

Dosage Form

-

Strength

20MG/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: 8845

Drug Name

QUELICIN PRESERVATIVE FREE

Product Number

2

Dosage Form

-

Strength

50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

8845 / 2

Active Ingredient

SUCCINYLCHOLINE CHLORIDE

Application Number

8845

Product Number

2

Dosage Form

-

Strength

50MG/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: 8845

Drug Name

QUELICIN PRESERVATIVE FREE

Product Number

4

Dosage Form

-

Strength

100MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

8845 / 4

Active Ingredient

SUCCINYLCHOLINE CHLORIDE

Application Number

8845

Product Number

4

Dosage Form

-

Strength

100MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

2022
31 Aug
RX Application: 214349

Drug Name

REGADENOSON

Product Number

1

Dosage Form

-

Strength

0.4MG/5ML (0.08MG/ML)

Approval Date

2022-08-31

214349 / 1

Active Ingredient

REGADENOSON

Application Number

214349

Product Number

1

Dosage Form

-

Strength

0.4MG/5ML (0.08MG/ML)

Approval Date

2022-08-31

Regulatory Status

RX

-
Unclassified Application: 125545

Drug Name

RETACRIT

Product Number

1

Dosage Form

-

Strength

2,000UNITS/ML

Approval Date

-

125545 / 1

Active Ingredient

EPOETIN ALFA-EPBX

Application Number

125545

Product Number

1

Dosage Form

-

Strength

2,000UNITS/ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 125545

Drug Name

RETACRIT

Product Number

2

Dosage Form

-

Strength

3,000UNITS/ML

Approval Date

-

125545 / 2

Active Ingredient

EPOETIN ALFA-EPBX

Application Number

125545

Product Number

2

Dosage Form

-

Strength

3,000UNITS/ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 125545

Drug Name

RETACRIT

Product Number

3

Dosage Form

-

Strength

4,000UNITS/ML

Approval Date

-

125545 / 3

Active Ingredient

EPOETIN ALFA-EPBX

Application Number

125545

Product Number

3

Dosage Form

-

Strength

4,000UNITS/ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 125545

Drug Name

RETACRIT

Product Number

4

Dosage Form

-

Strength

10,000UNITS/ML

Approval Date

-

125545 / 4

Active Ingredient

EPOETIN ALFA-EPBX

Application Number

125545

Product Number

4

Dosage Form

-

Strength

10,000UNITS/ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 125545

Drug Name

RETACRIT

Product Number

5

Dosage Form

-

Strength

40,000UNITS/ML

Approval Date

-

125545 / 5

Active Ingredient

EPOETIN ALFA-EPBX

Application Number

125545

Product Number

5

Dosage Form

-

Strength

40,000UNITS/ML

Approval Date

-

Regulatory Status

Unclassified

1991
28 Feb
Discontinued Application: 71618

Drug Name

RITODRINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1991-02-28

71618 / 1

Active Ingredient

RITODRINE HYDROCHLORIDE

Application Number

71618

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1991-02-28

Regulatory Status

Discontinued

1991
28 Feb
Discontinued Application: 71619

Drug Name

RITODRINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

15MG/ML

Approval Date

1991-02-28

71619 / 1

Active Ingredient

RITODRINE HYDROCHLORIDE

Application Number

71619

Product Number

1

Dosage Form

-

Strength

15MG/ML

Approval Date

1991-02-28

Regulatory Status

Discontinued

1991
22 Jan
Discontinued Application: 71438

Drug Name

RITODRINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

30MG/100ML

Approval Date

1991-01-22

71438 / 1

Active Ingredient

RITODRINE HYDROCHLORIDE

Application Number

71438

Product Number

1

Dosage Form

-

Strength

30MG/100ML

Approval Date

1991-01-22

Regulatory Status

Discontinued

2008
26 Nov
RX Application: 78519

Drug Name

ROCURONIUM BROMIDE

Product Number

1

Dosage Form

-

Strength

50MG/5ML (10MG/ML)

Approval Date

2008-11-26

78519 / 1

Active Ingredient

ROCURONIUM BROMIDE

Application Number

78519

Product Number

1

Dosage Form

-

Strength

50MG/5ML (10MG/ML)

Approval Date

2008-11-26

Regulatory Status

RX

2008
26 Nov
RX Application: 78519

Drug Name

ROCURONIUM BROMIDE

Product Number

2

Dosage Form

-

Strength

100MG/10ML (10MG/ML)

Approval Date

2008-11-26

78519 / 2

Active Ingredient

ROCURONIUM BROMIDE

Application Number

78519

Product Number

2

Dosage Form

-

Strength

100MG/10ML (10MG/ML)

Approval Date

2008-11-26

Regulatory Status

RX

2014
23 Sep
Discontinued Application: 90194

Drug Name

ROPIVACAINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

20MG/10ML (2MG/ML)

Approval Date

2014-09-23

90194 / 1

Active Ingredient

ROPIVACAINE HYDROCHLORIDE

Application Number

90194

Product Number

1

Dosage Form

-

Strength

20MG/10ML (2MG/ML)

Approval Date

2014-09-23

Regulatory Status

Discontinued

2014
23 Sep
Discontinued Application: 90194

Drug Name

ROPIVACAINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

150MG/30ML (5MG/ML)

Approval Date

2014-09-23

90194 / 2

Active Ingredient

ROPIVACAINE HYDROCHLORIDE

Application Number

90194

Product Number

2

Dosage Form

-

Strength

150MG/30ML (5MG/ML)

Approval Date

2014-09-23

Regulatory Status

Discontinued

2014
23 Sep
Discontinued Application: 90194

Drug Name

ROPIVACAINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

150MG/20ML (7.5MG/ML)

Approval Date

2014-09-23

90194 / 3

Active Ingredient

ROPIVACAINE HYDROCHLORIDE

Application Number

90194

Product Number

3

Dosage Form

-

Strength

150MG/20ML (7.5MG/ML)

Approval Date

2014-09-23

Regulatory Status

Discontinued

2014
23 Sep
Discontinued Application: 90194

Drug Name

ROPIVACAINE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

100MG/10ML (10MG/ML)

Approval Date

2014-09-23

90194 / 4

Active Ingredient

ROPIVACAINE HYDROCHLORIDE

Application Number

90194

Product Number

4

Dosage Form

-

Strength

100MG/10ML (10MG/ML)

Approval Date

2014-09-23

Regulatory Status

Discontinued

2014
23 Sep
Discontinued Application: 90194

Drug Name

ROPIVACAINE HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

40MG/20ML (2MG/ML)

Approval Date

2014-09-23

90194 / 5

Active Ingredient

ROPIVACAINE HYDROCHLORIDE

Application Number

90194

Product Number

5

Dosage Form

-

Strength

40MG/20ML (2MG/ML)

Approval Date

2014-09-23

Regulatory Status

Discontinued

2014
23 Sep
Discontinued Application: 90194

Drug Name

ROPIVACAINE HYDROCHLORIDE

Product Number

6

Dosage Form

-

Strength

200MG/20ML (10MG/ML)

Approval Date

2014-09-23

90194 / 6

Active Ingredient

ROPIVACAINE HYDROCHLORIDE

Application Number

90194

Product Number

6

Dosage Form

-

Strength

200MG/20ML (10MG/ML)

Approval Date

2014-09-23

Regulatory Status

Discontinued

1983
04 May
RX Application: 18893

Drug Name

SODIUM ACETATE

Product Number

1

Dosage Form

-

Strength

40MEQ/20ML (2MEQ/ML)

Approval Date

1983-05-04

18893 / 1

Active Ingredient

SODIUM ACETATE

Application Number

18893

Product Number

1

Dosage Form

-

Strength

40MEQ/20ML (2MEQ/ML)

Approval Date

1983-05-04

Regulatory Status

RX

2014
02 Sep
RX Application: 18893

Drug Name

SODIUM ACETATE

Product Number

2

Dosage Form

-

Strength

100MEQ/50ML (2MEQ/ML)

Approval Date

2014-09-02

18893 / 2

Active Ingredient

SODIUM ACETATE

Application Number

18893

Product Number

2

Dosage Form

-

Strength

100MEQ/50ML (2MEQ/ML)

Approval Date

2014-09-02

Regulatory Status

RX

2014
02 Sep
RX Application: 18893

Drug Name

SODIUM ACETATE

Product Number

3

Dosage Form

-

Strength

200MEQ/100ML (2MEQ/ML)

Approval Date

2014-09-02

18893 / 3

Active Ingredient

SODIUM ACETATE

Application Number

18893

Product Number

3

Dosage Form

-

Strength

200MEQ/100ML (2MEQ/ML)

Approval Date

2014-09-02

Regulatory Status

RX

2005
09 Nov
Discontinued Application: 77394

Drug Name

SODIUM BICARBONATE

Product Number

1

Dosage Form

-

Strength

44.6MEQ/50ML (0.9MEQ/ML)

Approval Date

2005-11-09

77394 / 1

Active Ingredient

SODIUM BICARBONATE

Application Number

77394

Product Number

1

Dosage Form

-

Strength

44.6MEQ/50ML (0.9MEQ/ML)

Approval Date

2005-11-09

Regulatory Status

Discontinued

2005
09 Nov
Discontinued Application: 77394

Drug Name

SODIUM BICARBONATE

Product Number

2

Dosage Form

-

Strength

50MEQ/50ML (1MEQ/ML)

Approval Date

2005-11-09

77394 / 2

Active Ingredient

SODIUM BICARBONATE

Application Number

77394

Product Number

2

Dosage Form

-

Strength

50MEQ/50ML (1MEQ/ML)

Approval Date

2005-11-09

Regulatory Status

Discontinued

2017
26 Sep
RX Application: 202432

Drug Name

SODIUM BICARBONATE

Product Number

1

Dosage Form

-

Strength

50MEQ/50ML (1MEQ/ML)

Approval Date

2017-09-26

202432 / 1

Active Ingredient

SODIUM BICARBONATE

Application Number

202432

Product Number

1

Dosage Form

-

Strength

50MEQ/50ML (1MEQ/ML)

Approval Date

2017-09-26

Regulatory Status

RX

2017
06 Mar
RX Application: 202494

Drug Name

SODIUM BICARBONATE

Product Number

1

Dosage Form

-

Strength

44.6MEQ/50ML (0.9MEQ/ML)

Approval Date

2017-03-06

202494 / 1

Active Ingredient

SODIUM BICARBONATE

Application Number

202494

Product Number

1

Dosage Form

-

Strength

44.6MEQ/50ML (0.9MEQ/ML)

Approval Date

2017-03-06

Regulatory Status

RX

2017
06 Mar
RX Application: 202494

Drug Name

SODIUM BICARBONATE

Product Number

2

Dosage Form

-

Strength

50MEQ/50ML (1MEQ/ML)

Approval Date

2017-03-06

202494 / 2

Active Ingredient

SODIUM BICARBONATE

Application Number

202494

Product Number

2

Dosage Form

-

Strength

50MEQ/50ML (1MEQ/ML)

Approval Date

2017-03-06

Regulatory Status

RX

2017
06 Mar
RX Application: 202495

Drug Name

SODIUM BICARBONATE

Product Number

1

Dosage Form

-

Strength

10MEQ/10ML (1MEQ/ML)

Approval Date

2017-03-06

202495 / 1

Active Ingredient

SODIUM BICARBONATE

Application Number

202495

Product Number

1

Dosage Form

-

Strength

10MEQ/10ML (1MEQ/ML)

Approval Date

2017-03-06

Regulatory Status

RX

2017
07 Mar
RX Application: 202679

Drug Name

SODIUM BICARBONATE

Product Number

1

Dosage Form

-

Strength

5MEQ/10ML (0.5MEQ/ML)

Approval Date

2017-03-07

202679 / 1

Active Ingredient

SODIUM BICARBONATE

Application Number

202679

Product Number

1

Dosage Form

-

Strength

5MEQ/10ML (0.5MEQ/ML)

Approval Date

2017-03-07

Regulatory Status

RX

2016
04 Mar
RX Application: 202981

Drug Name

SODIUM BICARBONATE

Product Number

1

Dosage Form

-

Strength

2.5MEQ/5ML (0.5MEQ/ML)

Approval Date

2016-03-04

202981 / 1

Active Ingredient

SODIUM BICARBONATE

Application Number

202981

Product Number

1

Dosage Form

-

Strength

2.5MEQ/5ML (0.5MEQ/ML)

Approval Date

2016-03-04

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 17670

Drug Name

SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

450MG/100ML

Approval Date

1982-01-01

17670 / 1

Active Ingredient

SODIUM CHLORIDE

Application Number

17670

Product Number

1

Dosage Form

-

Strength

450MG/100ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 18380

Drug Name

SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

450MG/100ML

Approval Date

1982-01-01

18380 / 1

Active Ingredient

SODIUM CHLORIDE

Application Number

18380

Product Number

1

Dosage Form

-

Strength

450MG/100ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1988
08 Jun
RX Application: 19759

Drug Name

SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

450MG/100ML

Approval Date

1988-06-08

19759 / 1

Active Ingredient

SODIUM CHLORIDE

Application Number

19759

Product Number

1

Dosage Form

-

Strength

450MG/100ML

Approval Date

1988-06-08

Regulatory Status

RX

1982
29 Oct
RX Application: 18803

Drug Name

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

90MG/10ML (9MG/ML)

Approval Date

1982-10-29

18803 / 1

Active Ingredient

SODIUM CHLORIDE

Application Number

18803

Product Number

1

Dosage Form

-

Strength

90MG/10ML (9MG/ML)

Approval Date

1982-10-29

Regulatory Status

RX

1982
29 Oct
RX Application: 18803

Drug Name

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

180MG/20ML (9MG/ML)

Approval Date

1982-10-29

18803 / 2

Active Ingredient

SODIUM CHLORIDE

Application Number

18803

Product Number

2

Dosage Form

-

Strength

180MG/20ML (9MG/ML)

Approval Date

1982-10-29

Regulatory Status

RX

1982
29 Oct
RX Application: 18803

Drug Name

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

3

Dosage Form

-

Strength

450MG/50ML (9MG/ML)

Approval Date

1982-10-29

18803 / 3

Active Ingredient

SODIUM CHLORIDE

Application Number

18803

Product Number

3

Dosage Form

-

Strength

450MG/50ML (9MG/ML)

Approval Date

1982-10-29

Regulatory Status

RX

2015
22 Jan
Discontinued Application: 18803

Drug Name

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

4

Dosage Form

-

Strength

18MG/2ML (9MG/ML)

Approval Date

2015-01-22

18803 / 4

Active Ingredient

SODIUM CHLORIDE

Application Number

18803

Product Number

4

Dosage Form

-

Strength

18MG/2ML (9MG/ML)

Approval Date

2015-01-22

Regulatory Status

Discontinued

2015
22 Jan
Discontinued Application: 18803

Drug Name

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

5

Dosage Form

-

Strength

27MG/3ML (9MG/ML)

Approval Date

2015-01-22

18803 / 5

Active Ingredient

SODIUM CHLORIDE

Application Number

18803

Product Number

5

Dosage Form

-

Strength

27MG/3ML (9MG/ML)

Approval Date

2015-01-22

Regulatory Status

Discontinued

2015
22 Jan
Discontinued Application: 18803

Drug Name

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

6

Dosage Form

-

Strength

45MG/5ML (9MG/ML)

Approval Date

2015-01-22

18803 / 6

Active Ingredient

SODIUM CHLORIDE

Application Number

18803

Product Number

6

Dosage Form

-

Strength

45MG/5ML (9MG/ML)

Approval Date

2015-01-22

Regulatory Status

Discontinued

1985
15 Jul
RX Application: 19465

Drug Name

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

900MG/100ML

Approval Date

1985-07-15

19465 / 1

Active Ingredient

SODIUM CHLORIDE

Application Number

19465

Product Number

1

Dosage Form

-

Strength

900MG/100ML

Approval Date

1985-07-15

Regulatory Status

RX

1985
15 Jul
RX Application: 19465

Drug Name

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

450MG/50ML (9MG/ML)

Approval Date

1985-07-15

19465 / 2

Active Ingredient

SODIUM CHLORIDE

Application Number

19465

Product Number

2

Dosage Form

-

Strength

450MG/50ML (9MG/ML)

Approval Date

1985-07-15

Regulatory Status

RX

1985
17 Sep
RX Application: 19480

Drug Name

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

900MG/100ML

Approval Date

1985-09-17

19480 / 1

Active Ingredient

SODIUM CHLORIDE

Application Number

19480

Product Number

1

Dosage Form

-

Strength

900MG/100ML

Approval Date

1985-09-17

Regulatory Status

RX

1984
20 Jul
Discontinued Application: 18897

Drug Name

SODIUM CHLORIDE 14.6%

Product Number

1

Dosage Form

-

Strength

50MEQ/20ML (2.5MEQ/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1984-07-20

18897 / 1

Active Ingredient

SODIUM CHLORIDE

Application Number

18897

Product Number

1

Dosage Form

-

Strength

50MEQ/20ML (2.5MEQ/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1984-07-20

Regulatory Status

Discontinued

1984
20 Jul
RX Application: 18897

Drug Name

SODIUM CHLORIDE 14.6%

Product Number

2

Dosage Form

-

Strength

100MEQ/40ML (2.5MEQ/ML)

Approval Date

1984-07-20

18897 / 2

Active Ingredient

SODIUM CHLORIDE

Application Number

18897

Product Number

2

Dosage Form

-

Strength

100MEQ/40ML (2.5MEQ/ML)

Approval Date

1984-07-20

Regulatory Status

RX

2020
18 Jun
RX Application: 18897

Drug Name

SODIUM CHLORIDE 23.4%

Product Number

3

Dosage Form

-

Strength

400MEQ/100ML (4MEQ/ML)

Approval Date

2020-06-18

18897 / 3

Active Ingredient

SODIUM CHLORIDE

Application Number

18897

Product Number

3

Dosage Form

-

Strength

400MEQ/100ML (4MEQ/ML)

Approval Date

2020-06-18

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 18249

Drug Name

SODIUM LACTATE 0.167 MOLAR IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

1.87GM/100ML

Approval Date

1982-01-01

18249 / 1

Active Ingredient

SODIUM LACTATE

Application Number

18249

Product Number

1

Dosage Form

-

Strength

1.87GM/100ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1984
05 Sep
Discontinued Application: 18947

Drug Name

SODIUM LACTATE IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

5MEQ/ML

Approval Date

1984-09-05

18947 / 1

Active Ingredient

SODIUM LACTATE

Application Number

18947

Product Number

1

Dosage Form

-

Strength

5MEQ/ML

Approval Date

1984-09-05

Regulatory Status

Discontinued

1983
10 May
RX Application: 18892

Drug Name

SODIUM PHOSPHATES IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

4.02GM/15ML;4.14GM/15ML (268MG/ML;276MG/ML)

Approval Date

1983-05-10

18892 / 1

Active Ingredient

SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE

Application Number

18892

Product Number

1

Dosage Form

-

Strength

4.02GM/15ML;4.14GM/15ML (268MG/ML;276MG/ML)

Approval Date

1983-05-10

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 80224

Drug Name

SORBITOL-MANNITOL

Product Number

1

Dosage Form

-

Strength

540MG/100ML;2.7GM/100ML

Approval Date

1982-01-01

80224 / 1

Active Ingredient

MANNITOL; SORBITOL

Application Number

80224

Product Number

1

Dosage Form

-

Strength

540MG/100ML;2.7GM/100ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17636

Drug Name

SORBITOL-MANNITOL IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

540MG/100ML;2.7GM/100ML

Approval Date

1982-01-01

17636 / 1

Active Ingredient

MANNITOL; SORBITOL

Application Number

17636

Product Number

1

Dosage Form

-

Strength

540MG/100ML;2.7GM/100ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17698

Drug Name

STERILE UREA

Product Number

1

Dosage Form

-

Strength

40GM/VIAL

Approval Date

1982-01-01

17698 / 1

Active Ingredient

UREA

Application Number

17698

Product Number

1

Dosage Form

-

Strength

40GM/VIAL

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
27 Oct
Discontinued Application: 18801

Drug Name

STERILE WATER FOR INJECTION

Product Number

1

Dosage Form

-

Strength

100% (1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-10-27

18801 / 1

Active Ingredient

STERILE WATER FOR INJECTION

Application Number

18801

Product Number

1

Dosage Form

-

Strength

100% (1ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-10-27

Regulatory Status

Discontinued

1982
27 Oct
RX Application: 18801

Drug Name

STERILE WATER FOR INJECTION

Product Number

2

Dosage Form

-

Strength

100% (10ML)

Approval Date

1982-10-27

18801 / 2

Active Ingredient

STERILE WATER FOR INJECTION

Application Number

18801

Product Number

2

Dosage Form

-

Strength

100% (10ML)

Approval Date

1982-10-27

Regulatory Status

RX

1982
27 Oct
RX Application: 18801

Drug Name

STERILE WATER FOR INJECTION

Product Number

3

Dosage Form

-

Strength

100% (20ML)

Approval Date

1982-10-27

18801 / 3

Active Ingredient

STERILE WATER FOR INJECTION

Application Number

18801

Product Number

3

Dosage Form

-

Strength

100% (20ML)

Approval Date

1982-10-27

Regulatory Status

RX

1982
27 Oct
RX Application: 18801

Drug Name

STERILE WATER FOR INJECTION

Product Number

4

Dosage Form

-

Strength

100% (50ML)

Approval Date

1982-10-27

18801 / 4

Active Ingredient

STERILE WATER FOR INJECTION

Application Number

18801

Product Number

4

Dosage Form

-

Strength

100% (50ML)

Approval Date

1982-10-27

Regulatory Status

RX

1982
27 Oct
RX Application: 18801

Drug Name

STERILE WATER FOR INJECTION

Product Number

5

Dosage Form

-

Strength

100% (100ML)

Approval Date

1982-10-27

18801 / 5

Active Ingredient

STERILE WATER FOR INJECTION

Application Number

18801

Product Number

5

Dosage Form

-

Strength

100% (100ML)

Approval Date

1982-10-27

Regulatory Status

RX

2023
02 May
RX Application: 18801

Drug Name

STERILE WATER FOR INJECTION

Product Number

6

Dosage Form

-

Strength

100% (5.2ML)

Approval Date

2023-05-02

18801 / 6

Active Ingredient

STERILE WATER FOR INJECTION

Application Number

18801

Product Number

6

Dosage Form

-

Strength

100% (5.2ML)

Approval Date

2023-05-02

Regulatory Status

RX

1996
11 Dec
RX Application: 74534

Drug Name

SUFENTANIL CITRATE

Product Number

1

Dosage Form

-

Strength

EQ 0.05MG BASE/ML

Approval Date

1996-12-11

74534 / 1

Active Ingredient

SUFENTANIL CITRATE

Application Number

74534

Product Number

1

Dosage Form

-

Strength

EQ 0.05MG BASE/ML

Approval Date

1996-12-11

Regulatory Status

RX

1992
11 Sep
Discontinued Application: 73199

Drug Name

SULFAMETHOXAZOLE AND TRIMETHOPRIM

Product Number

1

Dosage Form

-

Strength

80MG/ML;16MG/ML

Approval Date

1992-09-11

73199 / 1

Active Ingredient

SULFAMETHOXAZOLE; TRIMETHOPRIM

Application Number

73199

Product Number

1

Dosage Form

-

Strength

80MG/ML;16MG/ML

Approval Date

1992-09-11

Regulatory Status

Discontinued

2017
25 Aug
Discontinued Application: 203900

Drug Name

TACROLIMUS

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

2017-08-25

203900 / 1

Active Ingredient

TACROLIMUS

Application Number

203900

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

2017-08-25

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 16194

Drug Name

TALWIN

Product Number

1

Dosage Form

-

Strength

EQ 30MG BASE/ML

Approval Date

1982-01-01

16194 / 1

Active Ingredient

PENTAZOCINE LACTATE

Application Number

16194

Product Number

1

Dosage Form

-

Strength

EQ 30MG BASE/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1986
06 Mar
Discontinued Application: 62662

Drug Name

TAZICEF

Product Number

1

Dosage Form

-

Strength

500MG/VIAL

Approval Date

1986-03-06

62662 / 1

Active Ingredient

CEFTAZIDIME

Application Number

62662

Product Number

1

Dosage Form

-

Strength

500MG/VIAL

Approval Date

1986-03-06

Regulatory Status

Discontinued

1986
06 Mar
RX Application: 62662

Drug Name

TAZICEF

Product Number

2

Dosage Form

-

Strength

1GM/VIAL

Approval Date

1986-03-06

62662 / 2

Active Ingredient

CEFTAZIDIME

Application Number

62662

Product Number

2

Dosage Form

-

Strength

1GM/VIAL

Approval Date

1986-03-06

Regulatory Status

RX

1986
06 Mar
RX Application: 62662

Drug Name

TAZICEF

Product Number

3

Dosage Form

-

Strength

2GM/VIAL

Approval Date

1986-03-06

62662 / 3

Active Ingredient

CEFTAZIDIME

Application Number

62662

Product Number

3

Dosage Form

-

Strength

2GM/VIAL

Approval Date

1986-03-06

Regulatory Status

RX

1986
06 Mar
RX Application: 62662

Drug Name

TAZICEF

Product Number

4

Dosage Form

-

Strength

6GM/VIAL

Approval Date

1986-03-06

62662 / 4

Active Ingredient

CEFTAZIDIME

Application Number

62662

Product Number

4

Dosage Form

-

Strength

6GM/VIAL

Approval Date

1986-03-06

Regulatory Status

RX

1993
31 Oct
RX Application: 64032

Drug Name

TAZICEF

Product Number

1

Dosage Form

-

Strength

1GM/VIAL

Approval Date

1993-10-31

64032 / 1

Active Ingredient

CEFTAZIDIME

Application Number

64032

Product Number

1

Dosage Form

-

Strength

1GM/VIAL

Approval Date

1993-10-31

Regulatory Status

RX

1993
31 Oct
RX Application: 64032

Drug Name

TAZICEF

Product Number

2

Dosage Form

-

Strength

2GM/VIAL

Approval Date

1993-10-31

64032 / 2

Active Ingredient

CEFTAZIDIME

Application Number

64032

Product Number

2

Dosage Form

-

Strength

2GM/VIAL

Approval Date

1993-10-31

Regulatory Status

RX

1982
01 Jan
RX Application: 13025

Drug Name

THAM

Product Number

2

Dosage Form

-

Strength

18GM/500ML (3.6GM/100ML)

Approval Date

1982-01-01

13025 / 2

Active Ingredient

TROMETHAMINE

Application Number

13025

Product Number

2

Dosage Form

-

Strength

18GM/500ML (3.6GM/100ML)

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 13025

Drug Name

THAM-E

Product Number

1

Dosage Form

-

Strength

370MG/VIAL;1.75GM/VIAL;36GM/VIAL

Approval Date

1982-01-01

13025 / 1

Active Ingredient

POTASSIUM CHLORIDE; SODIUM CHLORIDE; TROMETHAMINE

Application Number

13025

Product Number

1

Dosage Form

-

Strength

370MG/VIAL;1.75GM/VIAL;36GM/VIAL

Approval Date

1982-01-01

Regulatory Status

Discontinued

1995
04 Jan
Discontinued Application: 89932

Drug Name

THEOPHYLLINE

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

1995-01-04

89932 / 1

Active Ingredient

THEOPHYLLINE

Application Number

89932

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

1995-01-04

Regulatory Status

Discontinued

1995
04 Jan
Discontinued Application: 89976

Drug Name

THEOPHYLLINE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1995-01-04

89976 / 1

Active Ingredient

THEOPHYLLINE

Application Number

89976

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1995-01-04

Regulatory Status

Discontinued

1995
04 Jan
Discontinued Application: 89977

Drug Name

THEOPHYLLINE

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1995-01-04

89977 / 1

Active Ingredient

THEOPHYLLINE

Application Number

89977

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1995-01-04

Regulatory Status

Discontinued

1984
14 Dec
Discontinued Application: 19211

Drug Name

THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

40MG/100ML

Approval Date

1984-12-14

19211 / 1

Active Ingredient

THEOPHYLLINE

Application Number

19211

Product Number

1

Dosage Form

-

Strength

40MG/100ML

Approval Date

1984-12-14

Regulatory Status

Discontinued

1984
14 Dec
Discontinued Application: 19211

Drug Name

THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

80MG/100ML

Approval Date

1984-12-14

19211 / 2

Active Ingredient

THEOPHYLLINE

Application Number

19211

Product Number

2

Dosage Form

-

Strength

80MG/100ML

Approval Date

1984-12-14

Regulatory Status

Discontinued

1984
14 Dec
Discontinued Application: 19211

Drug Name

THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

3

Dosage Form

-

Strength

160MG/100ML

Approval Date

1984-12-14

19211 / 3

Active Ingredient

THEOPHYLLINE

Application Number

19211

Product Number

3

Dosage Form

-

Strength

160MG/100ML

Approval Date

1984-12-14

Regulatory Status

Discontinued

1984
14 Dec
Discontinued Application: 19211

Drug Name

THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

4

Dosage Form

-

Strength

200MG/100ML

Approval Date

1984-12-14

19211 / 4

Active Ingredient

THEOPHYLLINE

Application Number

19211

Product Number

4

Dosage Form

-

Strength

200MG/100ML

Approval Date

1984-12-14

Regulatory Status

Discontinued

1984
14 Dec
Discontinued Application: 19211

Drug Name

THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

5

Dosage Form

-

Strength

400MG/100ML

Approval Date

1984-12-14

19211 / 5

Active Ingredient

THEOPHYLLINE

Application Number

19211

Product Number

5

Dosage Form

-

Strength

400MG/100ML

Approval Date

1984-12-14

Regulatory Status

Discontinued

1988
20 Jan
Discontinued Application: 19211

Drug Name

THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

6

Dosage Form

-

Strength

320MG/100ML

Approval Date

1988-01-20

19211 / 6

Active Ingredient

THEOPHYLLINE

Application Number

19211

Product Number

6

Dosage Form

-

Strength

320MG/100ML

Approval Date

1988-01-20

Regulatory Status

Discontinued

1984
14 Dec
Discontinued Application: 19211

Drug Name

THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

7

Dosage Form

-

Strength

4MG/ML

Approval Date

1984-12-14

19211 / 7

Active Ingredient

THEOPHYLLINE

Application Number

19211

Product Number

7

Dosage Form

-

Strength

4MG/ML

Approval Date

1984-12-14

Regulatory Status

Discontinued

1996
03 May
Discontinued Application: 40079

Drug Name

THIAMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

1996-05-03

40079 / 1

Active Ingredient

THIAMINE HYDROCHLORIDE

Application Number

40079

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

1996-05-03

Regulatory Status

Discontinued

1991
30 Apr
Discontinued Application: 63080

Drug Name

TOBRAMYCIN SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

1991-04-30

63080 / 1

Active Ingredient

TOBRAMYCIN SULFATE

Application Number

63080

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

1991-04-30

Regulatory Status

Discontinued

1991
30 Apr
RX Application: 63111

Drug Name

TOBRAMYCIN SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE/ML

Approval Date

1991-04-30

63111 / 1

Active Ingredient

TOBRAMYCIN SULFATE

Application Number

63111

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE/ML

Approval Date

1991-04-30

Regulatory Status

RX

1991
30 Apr
Discontinued Application: 63112

Drug Name

TOBRAMYCIN SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

1991-04-30

63112 / 1

Active Ingredient

TOBRAMYCIN SULFATE

Application Number

63112

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

1991-04-30

Regulatory Status

Discontinued

1991
29 May
Discontinued Application: 63161

Drug Name

TOBRAMYCIN SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE/ML

Approval Date

1991-05-29

63161 / 1

Active Ingredient

TOBRAMYCIN SULFATE

Application Number

63161

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE/ML

Approval Date

1991-05-29

Regulatory Status

Discontinued

1992
18 May
Discontinued Application: 63116

Drug Name

TOBRAMYCIN SULFATE (PHARMACY BULK)

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1992-05-18

63116 / 1

Active Ingredient

TOBRAMYCIN SULFATE

Application Number

63116

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1992-05-18

Regulatory Status

Discontinued

1990
31 Jul
Discontinued Application: 63081

Drug Name

TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

EQ 80MG BASE/100ML

Approval Date

1990-07-31

63081 / 1

Active Ingredient

TOBRAMYCIN SULFATE

Application Number

63081

Product Number

1

Dosage Form

-

Strength

EQ 80MG BASE/100ML

Approval Date

1990-07-31

Regulatory Status

Discontinued

1990
31 Jul
Discontinued Application: 63081

Drug Name

TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

3

Dosage Form

-

Strength

EQ 1.2MG BASE/ML

Approval Date

1990-07-31

63081 / 3

Active Ingredient

TOBRAMYCIN SULFATE

Application Number

63081

Product Number

3

Dosage Form

-

Strength

EQ 1.2MG BASE/ML

Approval Date

1990-07-31

Regulatory Status

Discontinued

1993
02 Jun
Discontinued Application: 63081

Drug Name

TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

6

Dosage Form

-

Strength

EQ 1.6MG BASE/ML

Approval Date

1993-06-02

63081 / 6

Active Ingredient

TOBRAMYCIN SULFATE

Application Number

63081

Product Number

6

Dosage Form

-

Strength

EQ 1.6MG BASE/ML

Approval Date

1993-06-02

Regulatory Status

Discontinued

2011
02 Feb
RX Application: 200582

Drug Name

TOPOTECAN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2011-02-02

200582 / 1

Active Ingredient

TOPOTECAN HYDROCHLORIDE

Application Number

200582

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2011-02-02

Regulatory Status

RX

1984
20 Jul
RX Application: 18895

Drug Name

TPN ELECTROLYTES IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

16.5MG/ML;25.4MG/ML;74.6MG/ML;121MG/ML;16.1MG/ML

Approval Date

1984-07-20

18895 / 1

Active Ingredient

CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE

Application Number

18895

Product Number

1

Dosage Form

-

Strength

16.5MG/ML;25.4MG/ML;74.6MG/ML;121MG/ML;16.1MG/ML

Approval Date

1984-07-20

Regulatory Status

RX

1985
20 Jun
Discontinued Application: 18831

Drug Name

TRACRIUM

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1985-06-20

18831 / 2

Active Ingredient

ATRACURIUM BESYLATE

Application Number

18831

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1985-06-20

Regulatory Status

Discontinued

1983
23 Nov
Discontinued Application: 18831

Drug Name

TRACRIUM PRESERVATIVE FREE

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1983-11-23

18831 / 1

Active Ingredient

ATRACURIUM BESYLATE

Application Number

18831

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1983-11-23

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 18537

Drug Name

TRIDIL

Product Number

1

Dosage Form

-

Strength

5MG/ML

Approval Date

1982-01-01

18537 / 1

Active Ingredient

NITROGLYCERIN

Application Number

18537

Product Number

1

Dosage Form

-

Strength

5MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1983
16 Jun
Discontinued Application: 18537

Drug Name

TRIDIL

Product Number

2

Dosage Form

-

Strength

0.5MG/ML

Approval Date

1983-06-16

18537 / 2

Active Ingredient

NITROGLYCERIN

Application Number

18537

Product Number

2

Dosage Form

-

Strength

0.5MG/ML

Approval Date

1983-06-16

Regulatory Status

Discontinued

1987
03 Apr
Discontinued Application: 88804

Drug Name

TRIMETHOBENZAMIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

1987-04-03

88804 / 1

Active Ingredient

TRIMETHOBENZAMIDE HYDROCHLORIDE

Application Number

88804

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

1987-04-03

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 6095

Drug Name

TUBOCURARINE CHLORIDE

Product Number

1

Dosage Form

-

Strength

3MG/ML

Approval Date

1982-01-01

6095 / 1

Active Ingredient

TUBOCURARINE CHLORIDE

Application Number

6095

Product Number

1

Dosage Form

-

Strength

3MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 12154

Drug Name

UREAPHIL

Product Number

1

Dosage Form

-

Strength

40GM/VIAL

Approval Date

1982-01-01

12154 / 1

Active Ingredient

UREA

Application Number

12154

Product Number

1

Dosage Form

-

Strength

40GM/VIAL

Approval Date

1982-01-01

Regulatory Status

Discontinued

1983
27 May
Discontinued Application: 18904

Drug Name

UROLOGIC G IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

3.24GM/100ML;380MG/100ML;430MG/100ML

Approval Date

1983-05-27

18904 / 1

Active Ingredient

CITRIC ACID; MAGNESIUM OXIDE; SODIUM CARBONATE

Application Number

18904

Product Number

1

Dosage Form

-

Strength

3.24GM/100ML;380MG/100ML;430MG/100ML

Approval Date

1983-05-27

Regulatory Status

Discontinued

1988
04 Aug
RX Application: 62911

Drug Name

VANCOMYCIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1988-08-04

62911 / 1

Active Ingredient

VANCOMYCIN HYDROCHLORIDE

Application Number

62911

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1988-08-04

Regulatory Status

RX

1988
04 Aug
RX Application: 62912

Drug Name

VANCOMYCIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1988-08-04

62912 / 1

Active Ingredient

VANCOMYCIN HYDROCHLORIDE

Application Number

62912

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1988-08-04

Regulatory Status

RX

2009
07 Jan
RX Application: 62912

Drug Name

VANCOMYCIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 750MG BASE/VIAL

Approval Date

2009-01-07

62912 / 2

Active Ingredient

VANCOMYCIN HYDROCHLORIDE

Application Number

62912

Product Number

2

Dosage Form

-

Strength

EQ 750MG BASE/VIAL

Approval Date

2009-01-07

Regulatory Status

RX

2020
10 Jul
RX Application: 62912

Drug Name

VANCOMYCIN HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 1.5GM BASE/VIAL

Approval Date

2020-07-10

62912 / 3

Active Ingredient

VANCOMYCIN HYDROCHLORIDE

Application Number

62912

Product Number

3

Dosage Form

-

Strength

EQ 1.5GM BASE/VIAL

Approval Date

2020-07-10

Regulatory Status

RX

1992
29 Oct
RX Application: 62931

Drug Name

VANCOMYCIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1992-10-29

62931 / 1

Active Ingredient

VANCOMYCIN HYDROCHLORIDE

Application Number

62931

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

1992-10-29

Regulatory Status

RX

1992
29 Oct
RX Application: 62933

Drug Name

VANCOMYCIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1992-10-29

62933 / 1

Active Ingredient

VANCOMYCIN HYDROCHLORIDE

Application Number

62933

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1992-10-29

Regulatory Status

RX

2009
27 May
RX Application: 62933

Drug Name

VANCOMYCIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 750MG BASE/VIAL

Approval Date

2009-05-27

62933 / 2

Active Ingredient

VANCOMYCIN HYDROCHLORIDE

Application Number

62933

Product Number

2

Dosage Form

-

Strength

EQ 750MG BASE/VIAL

Approval Date

2009-05-27

Regulatory Status

RX

1990
21 Dec
RX Application: 63076

Drug Name

VANCOMYCIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 5GM BASE/VIAL

Approval Date

1990-12-21

63076 / 1

Active Ingredient

VANCOMYCIN HYDROCHLORIDE

Application Number

63076

Product Number

1

Dosage Form

-

Strength

EQ 5GM BASE/VIAL

Approval Date

1990-12-21

Regulatory Status

RX

2020
14 Sep
RX Application: 63076

Drug Name

VANCOMYCIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 10GM BASE/VIAL

Approval Date

2020-09-14

63076 / 2

Active Ingredient

VANCOMYCIN HYDROCHLORIDE

Application Number

63076

Product Number

2

Dosage Form

-

Strength

EQ 10GM BASE/VIAL

Approval Date

2020-09-14

Regulatory Status

RX

2009
29 Apr
Discontinued Application: 65455

Drug Name

VANCOMYCIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 10GM BASE/VIAL

Approval Date

2009-04-29

65455 / 1

Active Ingredient

VANCOMYCIN HYDROCHLORIDE

Application Number

65455

Product Number

1

Dosage Form

-

Strength

EQ 10GM BASE/VIAL

Approval Date

2009-04-29

Regulatory Status

Discontinued

1999
21 Oct
RX Application: 75164

Drug Name

VECURONIUM BROMIDE

Product Number

1

Dosage Form

-

Strength

10MG/VIAL

Approval Date

1999-10-21

75164 / 1

Active Ingredient

VECURONIUM BROMIDE

Application Number

75164

Product Number

1

Dosage Form

-

Strength

10MG/VIAL

Approval Date

1999-10-21

Regulatory Status

RX

1999
21 Oct
RX Application: 75164

Drug Name

VECURONIUM BROMIDE

Product Number

2

Dosage Form

-

Strength

20MG/VIAL

Approval Date

1999-10-21

75164 / 2

Active Ingredient

VECURONIUM BROMIDE

Application Number

75164

Product Number

2

Dosage Form

-

Strength

20MG/VIAL

Approval Date

1999-10-21

Regulatory Status

RX

2001
11 Sep
Discontinued Application: 75558

Drug Name

VECURONIUM BROMIDE

Product Number

1

Dosage Form

-

Strength

4MG/VIAL

Approval Date

2001-09-11

75558 / 1

Active Ingredient

VECURONIUM BROMIDE

Application Number

75558

Product Number

1

Dosage Form

-

Strength

4MG/VIAL

Approval Date

2001-09-11

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17957

Drug Name

VEINAMINE 8%

Product Number

1

Dosage Form

-

Strength

8%;61MG/100ML;211MG/100ML;56MG/100ML;388MG/100ML

Approval Date

1982-01-01

17957 / 1

Active Ingredient

AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM ACETATE; POTASSIUM CHLORIDE; SODIUM ACETATE

Application Number

17957

Product Number

1

Dosage Form

-

Strength

8%;61MG/100ML;211MG/100ML;56MG/100ML;388MG/100ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1987
02 Feb
Discontinued Application: 70577

Drug Name

VERAPAMIL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

2.5MG/ML

Approval Date

1987-02-02

70577 / 1

Active Ingredient

VERAPAMIL HYDROCHLORIDE

Application Number

70577

Product Number

1

Dosage Form

-

Strength

2.5MG/ML

Approval Date

1987-02-02

Regulatory Status

Discontinued

1987
06 May
RX Application: 70737

Drug Name

VERAPAMIL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG/2ML (2.5MG/ML)

Approval Date

1987-05-06

70737 / 1

Active Ingredient

VERAPAMIL HYDROCHLORIDE

Application Number

70737

Product Number

1

Dosage Form

-

Strength

5MG/2ML (2.5MG/ML)

Approval Date

1987-05-06

Regulatory Status

RX

1987
06 May
RX Application: 70737

Drug Name

VERAPAMIL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG/4ML (2.5MG/ML)

Approval Date

1987-05-06

70737 / 2

Active Ingredient

VERAPAMIL HYDROCHLORIDE

Application Number

70737

Product Number

2

Dosage Form

-

Strength

10MG/4ML (2.5MG/ML)

Approval Date

1987-05-06

Regulatory Status

RX

1987
06 May
RX Application: 70738

Drug Name

VERAPAMIL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG/2ML (2.5MG/ML)

Approval Date

1987-05-06

70738 / 1

Active Ingredient

VERAPAMIL HYDROCHLORIDE

Application Number

70738

Product Number

1

Dosage Form

-

Strength

5MG/2ML (2.5MG/ML)

Approval Date

1987-05-06

Regulatory Status

RX

1987
06 May
Discontinued Application: 70739

Drug Name

VERAPAMIL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

2.5MG/ML

Approval Date

1987-05-06

70739 / 1

Active Ingredient

VERAPAMIL HYDROCHLORIDE

Application Number

70739

Product Number

1

Dosage Form

-

Strength

2.5MG/ML

Approval Date

1987-05-06

Regulatory Status

Discontinued

1987
06 May
Discontinued Application: 70740

Drug Name

VERAPAMIL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

2.5MG/ML

Approval Date

1987-05-06

70740 / 1

Active Ingredient

VERAPAMIL HYDROCHLORIDE

Application Number

70740

Product Number

1

Dosage Form

-

Strength

2.5MG/ML

Approval Date

1987-05-06

Regulatory Status

Discontinued

1998
20 Oct
Discontinued Application: 75136

Drug Name

VERAPAMIL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG/4ML (2.5MG/ML)

Approval Date

1998-10-20

75136 / 1

Active Ingredient

VERAPAMIL HYDROCHLORIDE

Application Number

75136

Product Number

1

Dosage Form

-

Strength

10MG/4ML (2.5MG/ML)

Approval Date

1998-10-20

Regulatory Status

Discontinued

1987
18 Aug
Discontinued Application: 89565

Drug Name

VINBLASTINE SULFATE

Product Number

1

Dosage Form

-

Strength

10MG/VIAL

Approval Date

1987-08-18

89565 / 1

Active Ingredient

VINBLASTINE SULFATE

Application Number

89565

Product Number

1

Dosage Form

-

Strength

10MG/VIAL

Approval Date

1987-08-18

Regulatory Status

Discontinued

1988
11 Apr
Discontinued Application: 71559

Drug Name

VINCRISTINE SULFATE

Product Number

1

Dosage Form

-

Strength

1MG/VIAL

Approval Date

1988-04-11

71559 / 1

Active Ingredient

VINCRISTINE SULFATE

Application Number

71559

Product Number

1

Dosage Form

-

Strength

1MG/VIAL

Approval Date

1988-04-11

Regulatory Status

Discontinued

1988
11 Apr
Discontinued Application: 71560

Drug Name

VINCRISTINE SULFATE

Product Number

1

Dosage Form

-

Strength

2MG/VIAL

Approval Date

1988-04-11

71560 / 1

Active Ingredient

VINCRISTINE SULFATE

Application Number

71560

Product Number

1

Dosage Form

-

Strength

2MG/VIAL

Approval Date

1988-04-11

Regulatory Status

Discontinued

1988
11 Apr
Discontinued Application: 71561

Drug Name

VINCRISTINE SULFATE

Product Number

1

Dosage Form

-

Strength

5MG/VIAL

Approval Date

1988-04-11

71561 / 1

Active Ingredient

VINCRISTINE SULFATE

Application Number

71561

Product Number

1

Dosage Form

-

Strength

5MG/VIAL

Approval Date

1988-04-11

Regulatory Status

Discontinued

1988
19 Apr
RX Application: 71484

Drug Name

VINCRISTINE SULFATE PFS

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

1988-04-19

71484 / 1

Active Ingredient

VINCRISTINE SULFATE

Application Number

71484

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

1988-04-19

Regulatory Status

RX

2005
02 Jun
Discontinued Application: 76827

Drug Name

VINORELBINE TARTRATE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

2005-06-02

76827 / 1

Active Ingredient

VINORELBINE TARTRATE

Application Number

76827

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

2005-06-02

Regulatory Status

Discontinued

1983
25 Jul
RX Application: 87954

Drug Name

VITAMIN K1

Product Number

1

Dosage Form

-

Strength

1MG/0.5ML

Approval Date

1983-07-25

87954 / 1

Active Ingredient

PHYTONADIONE

Application Number

87954

Product Number

1

Dosage Form

-

Strength

1MG/0.5ML

Approval Date

1983-07-25

Regulatory Status

RX

1983
25 Jul
RX Application: 87955

Drug Name

VITAMIN K1

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1983-07-25

87955 / 1

Active Ingredient

PHYTONADIONE

Application Number

87955

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1983-07-25

Regulatory Status

RX

1983
25 Jul
Discontinued Application: 87956

Drug Name

VITAMIN K1

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1983-07-25

87956 / 1

Active Ingredient

PHYTONADIONE

Application Number

87956

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1983-07-25

Regulatory Status

Discontinued

1993
29 Dec
Discontinued Application: 20176

Drug Name

VITAPED

Product Number

1

Dosage Form

-

Strength

N/A,80MG/VIAL;N/A,0.02MG/VIAL;N/A,0.001MG/VIAL;400 IU/10ML,N/A;N/A,0.14MG/VIAL;N/A,17MG/VIAL;N/A,5MG/VIAL;0.2MG/10ML,N/A;N/A,1MG/VIAL;N/A,1.4MG/VIAL;N/A,1.2MG/VIAL;EQ 2,300 UNITS BASE/10ML,N/A;7 IU/10ML,N/A

Approval Date

1993-12-29

20176 / 1

Active Ingredient

ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PANTOTHENIC ACID; PHYTONADIONE; PYRIDOXINE; RIBOFLAVIN; THIAMINE; VITAMIN A PALMITATE; VITAMIN E

Application Number

20176

Product Number

1

Dosage Form

-

Strength

N/A,80MG/VIAL;N/A,0.02MG/VIAL;N/A,0.001MG/VIAL;400 IU/10ML,N/A;N/A,0.14MG/VIAL;N/A,17MG/VIAL;N/A,5MG/VIAL;0.2MG/10ML,N/A;N/A,1MG/VIAL;N/A,1.4MG/VIAL;N/A,1.2MG/VIAL;EQ 2,300 UNITS BASE/10ML,N/A;7 IU/10ML,N/A

Approval Date

1993-12-29

Regulatory Status

Discontinued

1986
26 Jun
RX Application: 18959

Drug Name

ZINC CHLORIDE IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

EQ 1MG ZINC/ML

Approval Date

1986-06-26

18959 / 1

Active Ingredient

ZINC CHLORIDE

Application Number

18959

Product Number

1

Dosage Form

-

Strength

EQ 1MG ZINC/ML

Approval Date

1986-06-26

Regulatory Status

RX

2015
19 Mar
Discontinued Application: 90621

Drug Name

ZOLEDRONIC ACID

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE/5ML

Approval Date

2015-03-19

90621 / 1

Active Ingredient

ZOLEDRONIC ACID

Application Number

90621

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE/5ML

Approval Date

2015-03-19

Regulatory Status

Discontinued

-
Unclassified Application: 90709

Drug Name

ZOLEDRONIC ACID

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE/5ML

Approval Date

-

90709 / 1

Active Ingredient

ZOLEDRONIC ACID

Application Number

90709

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE/5ML

Approval Date

-

Regulatory Status

Unclassified

2013
05 Apr
Discontinued Application: 202837

Drug Name

ZOLEDRONIC ACID

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/100ML

Approval Date

2013-04-05

202837 / 1

Active Ingredient

ZOLEDRONIC ACID

Application Number

202837

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/100ML

Approval Date

2013-04-05

Regulatory Status

Discontinued

2015
28 Dec
Discontinued Application: 204016

Drug Name

ZOLEDRONIC ACID

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE/100ML (EQ 0.04MG BASE/ML)

Approval Date

2015-12-28

204016 / 1

Active Ingredient

ZOLEDRONIC ACID

Application Number

204016

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE/100ML (EQ 0.04MG BASE/ML)

Approval Date

2015-12-28

Regulatory Status

Discontinued

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Drug Status Breakdown
863 total
  • Discontinued
  • RX
  • Unclassified
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

A-HYDROCORT

Application Number

40666

Product Number

1

Active Ingredient

HYDROCORTISONE SODIUM SUCCINATE

Dosage Form

-

Strength

EQ 100MG BASE/VIAL

FDA Approved Drug Data

Approved drug product information

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