Bausch Health
FDA Approved Drugs

Bausch Health

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 95
  • Latest Approval Date Apr 15, 2011
  • Data Source FDA
  • First Approval Date Jan 01, 1982
All
95
View
Unclassified
1
View
Discontinued
79
View
RX
15
View
Company Overview

Company

Bausch Health

Country

Canada

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Company Snapshot

Bausch Health

2150 St. Elzear Blvd. WestLaval, Quebec H7L 4A8

Canada

www.bauschhealth.com/ View on Map
FDA Approved Drug Records ( 95 records )
1982
01 Jan
Discontinued Application: 9048

Drug Name

8-MOP

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

9048 / 1

Active Ingredient

METHOXSALEN

Application Number

9048

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85896

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;30MG

Approval Date

1982-01-01

85896 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Application Number

85896

Product Number

1

Dosage Form

-

Strength

300MG;30MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84563

Drug Name

AMINOPHYLLINE

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1982-01-01

84563 / 1

Active Ingredient

AMINOPHYLLINE

Application Number

84563

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 86450

Drug Name

ANDROID 10

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

86450 / 1

Active Ingredient

METHYLTESTOSTERONE

Application Number

86450

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 87222

Drug Name

ANDROID 5

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

87222 / 1

Active Ingredient

METHYLTESTOSTERONE

Application Number

87222

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 87196

Drug Name

ANDROID-F

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

87196 / 1

Active Ingredient

FLUOXYMESTERONE

Application Number

87196

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 16948

Drug Name

BENDOPA

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1982-01-01

16948 / 1

Active Ingredient

LEVODOPA

Application Number

16948

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 16948

Drug Name

BENDOPA

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

16948 / 2

Active Ingredient

LEVODOPA

Application Number

16948

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 16948

Drug Name

BENDOPA

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

16948 / 3

Active Ingredient

LEVODOPA

Application Number

16948

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 8173

Drug Name

BENOQUIN

Product Number

3

Dosage Form

-

Strength

20%

Approval Date

1982-01-01

8173 / 3

Active Ingredient

MONOBENZONE

Application Number

8173

Product Number

3

Dosage Form

-

Strength

20%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1984
26 Oct
RX Application: 50557

Drug Name

BENZAMYCIN

Product Number

1

Dosage Form

-

Strength

5%;3%

Approval Date

1984-10-26

50557 / 1

Active Ingredient

BENZOYL PEROXIDE; ERYTHROMYCIN

Application Number

50557

Product Number

1

Dosage Form

-

Strength

5%;3%

Approval Date

1984-10-26

Regulatory Status

RX

1982
21 Sep
Discontinued Application: 88021

Drug Name

BONTRIL

Product Number

1

Dosage Form

-

Strength

105MG

Approval Date

1982-09-21

88021 / 1

Active Ingredient

PHENDIMETRAZINE TARTRATE

Application Number

88021

Product Number

1

Dosage Form

-

Strength

105MG

Approval Date

1982-09-21

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 86024

Drug Name

CAPITAL AND CODEINE

Product Number

1

Dosage Form

-

Strength

120MG/5ML;12MG/5ML

Approval Date

1982-01-01

86024 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Application Number

86024

Product Number

1

Dosage Form

-

Strength

120MG/5ML;12MG/5ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 16721

Drug Name

DALMANE

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

16721 / 1

Active Ingredient

FLURAZEPAM HYDROCHLORIDE

Application Number

16721

Product Number

1

Dosage Form

-

Strength

15MG **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: 16721

Drug Name

DALMANE

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1982-01-01

16721 / 2

Active Ingredient

FLURAZEPAM HYDROCHLORIDE

Application Number

16721

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1982-01-01

Regulatory Status

Discontinued

1991
23 Sep
Discontinued Application: 19568

Drug Name

DERMATOP

Product Number

1

Dosage Form

-

Strength

0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1991-09-23

19568 / 1

Active Ingredient

PREDNICARBATE

Application Number

19568

Product Number

1

Dosage Form

-

Strength

0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1991-09-23

Regulatory Status

Discontinued

1993
29 Oct
Discontinued Application: 20279

Drug Name

DERMATOP E EMOLLIENT

Product Number

1

Dosage Form

-

Strength

0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1993-10-29

20279 / 1

Active Ingredient

PREDNICARBATE

Application Number

20279

Product Number

1

Dosage Form

-

Strength

0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1993-10-29

Regulatory Status

Discontinued

2000
11 Feb
RX Application: 75492

Drug Name

DICLOFENAC SODIUM

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2000-02-11

75492 / 1

Active Ingredient

DICLOFENAC SODIUM

Application Number

75492

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2000-02-11

Regulatory Status

RX

1999
23 Dec
RX Application: 75116

Drug Name

DILTIAZEM HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

120MG

Approval Date

1999-12-23

75116 / 1

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

75116

Product Number

1

Dosage Form

-

Strength

120MG

Approval Date

1999-12-23

Regulatory Status

RX

1999
23 Dec
RX Application: 75116

Drug Name

DILTIAZEM HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

180MG

Approval Date

1999-12-23

75116 / 2

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

75116

Product Number

2

Dosage Form

-

Strength

180MG

Approval Date

1999-12-23

Regulatory Status

RX

1999
23 Dec
RX Application: 75116

Drug Name

DILTIAZEM HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

240MG

Approval Date

1999-12-23

75116 / 3

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

75116

Product Number

3

Dosage Form

-

Strength

240MG

Approval Date

1999-12-23

Regulatory Status

RX

1999
23 Dec
RX Application: 75116

Drug Name

DILTIAZEM HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

300MG

Approval Date

1999-12-23

75116 / 4

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

75116

Product Number

4

Dosage Form

-

Strength

300MG

Approval Date

1999-12-23

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 80592

Drug Name

DIPHENHYDRAMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

80592 / 1

Active Ingredient

DIPHENHYDRAMINE HYDROCHLORIDE

Application Number

80592

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 80596

Drug Name

DIPHENHYDRAMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

80596 / 1

Active Ingredient

DIPHENHYDRAMINE HYDROCHLORIDE

Application Number

80596

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
16 Feb
Discontinued Application: 87195

Drug Name

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE

Product Number

1

Dosage Form

-

Strength

0.025MG;2.5MG

Approval Date

1982-02-16

87195 / 1

Active Ingredient

ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE

Application Number

87195

Product Number

1

Dosage Form

-

Strength

0.025MG;2.5MG

Approval Date

1982-02-16

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 80459

Drug Name

ELDECORT

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1982-01-01

80459 / 1

Active Ingredient

HYDROCORTISONE

Application Number

80459

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84055

Drug Name

ELDECORT

Product Number

1

Dosage Form

-

Strength

2.5%

Approval Date

1982-01-01

84055 / 1

Active Ingredient

HYDROCORTISONE

Application Number

84055

Product Number

1

Dosage Form

-

Strength

2.5%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1983
05 May
Discontinued Application: 88221

Drug Name

FLUOXYMESTERONE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1983-05-05

88221 / 1

Active Ingredient

FLUOXYMESTERONE

Application Number

88221

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1983-05-05

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 80903

Drug Name

FOLIC ACID

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

1982-01-01

80903 / 1

Active Ingredient

FOLIC ACID

Application Number

80903

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 62279

Drug Name

GRIFULVIN V

Product Number

1

Dosage Form

-

Strength

125MG

Approval Date

1982-01-01

62279 / 1

Active Ingredient

GRISEOFULVIN, MICROCRYSTALLINE

Application Number

62279

Product Number

1

Dosage Form

-

Strength

125MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 62279

Drug Name

GRIFULVIN V

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1982-01-01

62279 / 2

Active Ingredient

GRISEOFULVIN, MICROCRYSTALLINE

Application Number

62279

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 62279

Drug Name

GRIFULVIN V

Product Number

3

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

62279 / 3

Active Ingredient

GRISEOFULVIN, MICROSIZE

Application Number

62279

Product Number

3

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1984
26 Jan
Discontinued Application: 62483

Drug Name

GRIFULVIN V

Product Number

1

Dosage Form

-

Strength

125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1984-01-26

62483 / 1

Active Ingredient

GRISEOFULVIN, MICROSIZE

Application Number

62483

Product Number

1

Dosage Form

-

Strength

125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1984-01-26

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 80472

Drug Name

HYTONE

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1982-01-01

80472 / 3

Active Ingredient

HYDROCORTISONE

Application Number

80472

Product Number

3

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: 80472

Drug Name

HYTONE

Product Number

4

Dosage Form

-

Strength

2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

80472 / 4

Active Ingredient

HYDROCORTISONE

Application Number

80472

Product Number

4

Dosage Form

-

Strength

2.5% **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: 80473

Drug Name

HYTONE

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1982-01-01

80473 / 3

Active Ingredient

HYDROCORTISONE

Application Number

80473

Product Number

3

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
30 Nov
Discontinued Application: 80473

Drug Name

HYTONE

Product Number

4

Dosage Form

-

Strength

2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-11-30

80473 / 4

Active Ingredient

HYDROCORTISONE

Application Number

80473

Product Number

4

Dosage Form

-

Strength

2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-11-30

Regulatory Status

Discontinued

1991
19 Dec
Discontinued Application: 8719

Drug Name

LEVO-DROMORAN

Product Number

1

Dosage Form

-

Strength

2MG/ML

Approval Date

1991-12-19

8719 / 1

Active Ingredient

LEVORPHANOL TARTRATE

Application Number

8719

Product Number

1

Dosage Form

-

Strength

2MG/ML

Approval Date

1991-12-19

Regulatory Status

Discontinued

1991
19 Dec
Discontinued Application: 8720

Drug Name

LEVO-DROMORAN

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1991-12-19

8720 / 1

Active Ingredient

LEVORPHANOL TARTRATE

Application Number

8720

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1991-12-19

Regulatory Status

Discontinued

1983
12 Sep
Discontinued Application: 17813

Drug Name

LIBRELEASE

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

1983-09-12

17813 / 1

Active Ingredient

CHLORDIAZEPOXIDE

Application Number

17813

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

1983-09-12

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85481

Drug Name

LIBRITABS

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

85481 / 1

Active Ingredient

CHLORDIAZEPOXIDE

Application Number

85481

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85482

Drug Name

LIBRITABS

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

85482 / 1

Active Ingredient

CHLORDIAZEPOXIDE

Application Number

85482

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85488

Drug Name

LIBRITABS

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

85488 / 1

Active Ingredient

CHLORDIAZEPOXIDE

Application Number

85488

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 12249

Drug Name

LIBRIUM

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

12249 / 1

Active Ingredient

CHLORDIAZEPOXIDE HYDROCHLORIDE

Application Number

12249

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 12249

Drug Name

LIBRIUM

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1982-01-01

12249 / 2

Active Ingredient

CHLORDIAZEPOXIDE HYDROCHLORIDE

Application Number

12249

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 12249

Drug Name

LIBRIUM

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1982-01-01

12249 / 3

Active Ingredient

CHLORDIAZEPOXIDE HYDROCHLORIDE

Application Number

12249

Product Number

3

Dosage Form

-

Strength

25MG **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: 15139

Drug Name

MEPROBAMATE

Product Number

5

Dosage Form

-

Strength

400MG

Approval Date

1982-01-01

15139 / 5

Active Ingredient

MEPROBAMATE

Application Number

15139

Product Number

5

Dosage Form

-

Strength

400MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 15139

Drug Name

MEPROBAMATE

Product Number

6

Dosage Form

-

Strength

200MG

Approval Date

1982-01-01

15139 / 6

Active Ingredient

MEPROBAMATE

Application Number

15139

Product Number

6

Dosage Form

-

Strength

200MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1996
30 Aug
Discontinued Application: 89771

Drug Name

MINITRAN

Product Number

1

Dosage Form

-

Strength

0.1MG/HR

Approval Date

1996-08-30

89771 / 1

Active Ingredient

NITROGLYCERIN

Application Number

89771

Product Number

1

Dosage Form

-

Strength

0.1MG/HR

Approval Date

1996-08-30

Regulatory Status

Discontinued

1996
30 Aug
Discontinued Application: 89772

Drug Name

MINITRAN

Product Number

1

Dosage Form

-

Strength

0.2MG/HR

Approval Date

1996-08-30

89772 / 1

Active Ingredient

NITROGLYCERIN

Application Number

89772

Product Number

1

Dosage Form

-

Strength

0.2MG/HR

Approval Date

1996-08-30

Regulatory Status

Discontinued

1996
30 Aug
Discontinued Application: 89774

Drug Name

MINITRAN

Product Number

1

Dosage Form

-

Strength

0.6MG/HR

Approval Date

1996-08-30

89774 / 1

Active Ingredient

NITROGLYCERIN

Application Number

89774

Product Number

1

Dosage Form

-

Strength

0.6MG/HR

Approval Date

1996-08-30

Regulatory Status

Discontinued

1982
01 Jan
RX Application: 9170

Drug Name

MYSOLINE

Product Number

2

Dosage Form

-

Strength

250MG

Approval Date

1982-01-01

9170 / 2

Active Ingredient

PRIMIDONE

Application Number

9170

Product Number

2

Dosage Form

-

Strength

250MG

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 9170

Drug Name

MYSOLINE

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

9170 / 3

Active Ingredient

PRIMIDONE

Application Number

9170

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

Regulatory Status

RX

2000
04 Dec
RX Application: 75269

Drug Name

NIFEDIPINE

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

2000-12-04

75269 / 1

Active Ingredient

NIFEDIPINE

Application Number

75269

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

2000-12-04

Regulatory Status

RX

2000
04 Dec
RX Application: 75269

Drug Name

NIFEDIPINE

Product Number

2

Dosage Form

-

Strength

60MG

Approval Date

2000-12-04

75269 / 2

Active Ingredient

NIFEDIPINE

Application Number

75269

Product Number

2

Dosage Form

-

Strength

60MG

Approval Date

2000-12-04

Regulatory Status

RX

2000
27 Sep
RX Application: 75289

Drug Name

NIFEDIPINE

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

2000-09-27

75289 / 1

Active Ingredient

NIFEDIPINE

Application Number

75289

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

2000-09-27

Regulatory Status

RX

2001
06 Feb
RX Application: 75289

Drug Name

NIFEDIPINE

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2001-02-06

75289 / 2

Active Ingredient

NIFEDIPINE

Application Number

75289

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2001-02-06

Regulatory Status

RX

2002
16 Aug
RX Application: 76070

Drug Name

NIFEDIPINE

Product Number

1

Dosage Form

-

Strength

90MG

Approval Date

2002-08-16

76070 / 1

Active Ingredient

NIFEDIPINE

Application Number

76070

Product Number

1

Dosage Form

-

Strength

90MG

Approval Date

2002-08-16

Regulatory Status

RX

1988
01 Aug
Discontinued Application: 71961

Drug Name

NITROPRESS

Product Number

1

Dosage Form

-

Strength

25MG/ML

Approval Date

1988-08-01

71961 / 1

Active Ingredient

SODIUM NITROPRUSSIDE

Application Number

71961

Product Number

1

Dosage Form

-

Strength

25MG/ML

Approval Date

1988-08-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 9048

Drug Name

OXSORALEN

Product Number

2

Dosage Form

-

Strength

1%

Approval Date

1982-01-01

9048 / 2

Active Ingredient

METHOXSALEN

Application Number

9048

Product Number

2

Dosage Form

-

Strength

1%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1999
17 Dec
Discontinued Application: 21022

Drug Name

PENLAC

Product Number

1

Dosage Form

-

Strength

8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1999-12-17

21022 / 1

Active Ingredient

CICLOPIROX

Application Number

21022

Product Number

1

Dosage Form

-

Strength

8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1999-12-17

Regulatory Status

Discontinued

1988
30 Dec
Discontinued Application: 19385

Drug Name

PERMAX

Product Number

1

Dosage Form

-

Strength

EQ 0.05MG BASE

Approval Date

1988-12-30

19385 / 1

Active Ingredient

PERGOLIDE MESYLATE

Application Number

19385

Product Number

1

Dosage Form

-

Strength

EQ 0.05MG BASE

Approval Date

1988-12-30

Regulatory Status

Discontinued

1988
30 Dec
Discontinued Application: 19385

Drug Name

PERMAX

Product Number

2

Dosage Form

-

Strength

EQ 0.25MG BASE

Approval Date

1988-12-30

19385 / 2

Active Ingredient

PERGOLIDE MESYLATE

Application Number

19385

Product Number

2

Dosage Form

-

Strength

EQ 0.25MG BASE

Approval Date

1988-12-30

Regulatory Status

Discontinued

1988
30 Dec
Discontinued Application: 19385

Drug Name

PERMAX

Product Number

3

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

1988-12-30

19385 / 3

Active Ingredient

PERGOLIDE MESYLATE

Application Number

19385

Product Number

3

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

1988-12-30

Regulatory Status

Discontinued

1985
19 Jun
Discontinued Application: 87811

Drug Name

PHRENILIN

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1985-06-19

87811 / 1

Active Ingredient

ACETAMINOPHEN; BUTALBITAL

Application Number

87811

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1985-06-19

Regulatory Status

Discontinued

1985
19 Jun
Discontinued Application: 88831

Drug Name

PHRENILIN FORTE

Product Number

1

Dosage Form

-

Strength

650MG;50MG

Approval Date

1985-06-19

88831 / 1

Active Ingredient

ACETAMINOPHEN; BUTALBITAL

Application Number

88831

Product Number

1

Dosage Form

-

Strength

650MG;50MG

Approval Date

1985-06-19

Regulatory Status

Discontinued

2001
22 Aug
Discontinued Application: 74911

Drug Name

PHRENILIN WITH CAFFEINE AND CODEINE

Product Number

1

Dosage Form

-

Strength

325MG;50MG;40MG;30MG

Approval Date

2001-08-22

74911 / 1

Active Ingredient

ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE

Application Number

74911

Product Number

1

Dosage Form

-

Strength

325MG;50MG;40MG;30MG

Approval Date

2001-08-22

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 80236

Drug Name

PREDNISOLONE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

80236 / 1

Active Ingredient

PREDNISOLONE

Application Number

80236

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 80237

Drug Name

PREDNISONE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

80237 / 1

Active Ingredient

PREDNISONE

Application Number

80237

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 80783

Drug Name

PROPOXYPHENE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

65MG

Approval Date

1982-01-01

80783 / 1

Active Ingredient

PROPOXYPHENE HYDROCHLORIDE

Application Number

80783

Product Number

1

Dosage Form

-

Strength

65MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83393

Drug Name

QUINIDINE SULFATE

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1982-01-01

83393 / 1

Active Ingredient

QUINIDINE SULFATE

Application Number

83393

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 9668

Drug Name

RAUWOLFIA SERPENTINA

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

9668 / 1

Active Ingredient

RAUWOLFIA SERPENTINA ROOT

Application Number

9668

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 9668

Drug Name

RAUWOLFIA SERPENTINA

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

9668 / 2

Active Ingredient

RAUWOLFIA SERPENTINA ROOT

Application Number

9668

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1995
29 Dec
Discontinued Application: 19963

Drug Name

RENOVA

Product Number

1

Dosage Form

-

Strength

0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1995-12-29

19963 / 1

Active Ingredient

TRETINOIN

Application Number

19963

Product Number

1

Dosage Form

-

Strength

0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1995-12-29

Regulatory Status

Discontinued

2000
31 Aug
RX Application: 21108

Drug Name

RENOVA

Product Number

1

Dosage Form

-

Strength

0.02%

Approval Date

2000-08-31

21108 / 1

Active Ingredient

TRETINOIN

Application Number

21108

Product Number

1

Dosage Form

-

Strength

0.02%

Approval Date

2000-08-31

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 9667

Drug Name

RESERPINE

Product Number

1

Dosage Form

-

Strength

0.1MG

Approval Date

1982-01-01

9667 / 1

Active Ingredient

RESERPINE

Application Number

9667

Product Number

1

Dosage Form

-

Strength

0.1MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 9667

Drug Name

RESERPINE

Product Number

2

Dosage Form

-

Strength

0.25MG

Approval Date

1982-01-01

9667 / 2

Active Ingredient

RESERPINE

Application Number

9667

Product Number

2

Dosage Form

-

Strength

0.25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 16921

Drug Name

RETIN-A

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

1982-01-01

16921 / 1

Active Ingredient

TRETINOIN

Application Number

16921

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 16921

Drug Name

RETIN-A

Product Number

2

Dosage Form

-

Strength

0.05%

Approval Date

1982-01-01

16921 / 2

Active Ingredient

TRETINOIN

Application Number

16921

Product Number

2

Dosage Form

-

Strength

0.05%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
RX Application: 17579

Drug Name

RETIN-A

Product Number

2

Dosage Form

-

Strength

0.025%

Approval Date

1982-01-01

17579 / 2

Active Ingredient

TRETINOIN

Application Number

17579

Product Number

2

Dosage Form

-

Strength

0.025%

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 85477

Drug Name

SECOBARBITAL SODIUM

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

85477 / 1

Active Ingredient

SECOBARBITAL SODIUM

Application Number

85477

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1983
03 Oct
Discontinued Application: 86101

Drug Name

SECONAL SODIUM

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1983-10-03

86101 / 1

Active Ingredient

SECOBARBITAL SODIUM

Application Number

86101

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1983-10-03

Regulatory Status

Discontinued

1983
03 Oct
Discontinued Application: 86101

Drug Name

SECONAL SODIUM

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

1983-10-03

86101 / 2

Active Ingredient

SECOBARBITAL SODIUM

Application Number

86101

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

1983-10-03

Regulatory Status

Discontinued

-
Unclassified Application: 761032

Drug Name

SILIQ

Product Number

1

Dosage Form

-

Strength

210MG/1.5ML

Approval Date

-

761032 / 1

Active Ingredient

BRODALUMAB

Application Number

761032

Product Number

1

Dosage Form

-

Strength

210MG/1.5ML

Approval Date

-

Regulatory Status

Unclassified

1982
01 Jan
Discontinued Application: 83264

Drug Name

SODIUM PENTOBARBITAL

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

83264 / 1

Active Ingredient

PENTOBARBITAL SODIUM

Application Number

83264

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 80268

Drug Name

SULFISOXAZOLE

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

80268 / 2

Active Ingredient

SULFISOXAZOLE

Application Number

80268

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 60471

Drug Name

TETRACYCLINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1982-01-01

60471 / 1

Active Ingredient

TETRACYCLINE HYDROCHLORIDE

Application Number

60471

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 60471

Drug Name

TETRACYCLINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

60471 / 2

Active Ingredient

TETRACYCLINE HYDROCHLORIDE

Application Number

60471

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 12697

Drug Name

TRISORALEN

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

12697 / 1

Active Ingredient

TRIOXSALEN

Application Number

12697

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2005
08 Sep
Discontinued Application: 21692

Drug Name

ULTRAM ER

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2005-09-08

21692 / 1

Active Ingredient

TRAMADOL HYDROCHLORIDE

Application Number

21692

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2005-09-08

Regulatory Status

Discontinued

2005
08 Sep
Discontinued Application: 21692

Drug Name

ULTRAM ER

Product Number

2

Dosage Form

-

Strength

200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2005-09-08

21692 / 2

Active Ingredient

TRAMADOL HYDROCHLORIDE

Application Number

21692

Product Number

2

Dosage Form

-

Strength

200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2005-09-08

Regulatory Status

Discontinued

2005
08 Sep
Discontinued Application: 21692

Drug Name

ULTRAM ER

Product Number

3

Dosage Form

-

Strength

300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2005-09-08

21692 / 3

Active Ingredient

TRAMADOL HYDROCHLORIDE

Application Number

21692

Product Number

3

Dosage Form

-

Strength

300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2005-09-08

Regulatory Status

Discontinued

2011
15 Apr
Discontinued Application: 90071

Drug Name

VENLAFAXINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 37.5MG BASE

Approval Date

2011-04-15

90071 / 1

Active Ingredient

VENLAFAXINE HYDROCHLORIDE

Application Number

90071

Product Number

1

Dosage Form

-

Strength

EQ 37.5MG BASE

Approval Date

2011-04-15

Regulatory Status

Discontinued

2011
15 Apr
Discontinued Application: 90071

Drug Name

VENLAFAXINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2011-04-15

90071 / 2

Active Ingredient

VENLAFAXINE HYDROCHLORIDE

Application Number

90071

Product Number

2

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2011-04-15

Regulatory Status

Discontinued

2011
15 Apr
Discontinued Application: 90071

Drug Name

VENLAFAXINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2011-04-15

90071 / 3

Active Ingredient

VENLAFAXINE HYDROCHLORIDE

Application Number

90071

Product Number

3

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2011-04-15

Regulatory Status

Discontinued

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Drug Status Breakdown
95 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

8-MOP

Application Number

9048

Product Number

1

Active Ingredient

METHOXSALEN

Dosage Form

-

Strength

10MG

FDA Approved Drug Data

Approved drug product information

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Data maintained from official sources

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Searchable pharmaceutical data

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