Viatris Discontinued
FDA Approved Drugs

Viatris Discontinued

FDA Approved Drugs Database

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

Discontinued
  • Total Records 317
  • Latest Approval Date Mar 05, 2026
  • Data Source FDA
  • First Approval Date Jan 01, 1982
All
922
View
Unclassified
87
View
Discontinued
317
View
OTC
7
View
RX
511
View
Company Overview

Company

Viatris Discontinued

Country

U.S.A

Social Profiles

LinkedIn X / Twitter
Company Snapshot

Viatris Discontinued

Robert J. Coury Global Center 1000 Mylan Blvd. Canonsburg, PA 15317

U.S.A

www.viatris.com/en HRServiceCenter@Viatris.com View on Map
FDA Approved Drug Records ( 317 records )
2015
10 Sep
Discontinued Application: 203707

Drug Name

ACITRETIN

Product Number

1

Dosage Form

-

Strength

17.5MG

Approval Date

2015-09-10

203707 / 1

Active Ingredient

ACITRETIN

Application Number

203707

Product Number

1

Dosage Form

-

Strength

17.5MG

Approval Date

2015-09-10

Regulatory Status

Discontinued

2015
10 Sep
Discontinued Application: 203707

Drug Name

ACITRETIN

Product Number

2

Dosage Form

-

Strength

22.5MG

Approval Date

2015-09-10

203707 / 2

Active Ingredient

ACITRETIN

Application Number

203707

Product Number

2

Dosage Form

-

Strength

22.5MG

Approval Date

2015-09-10

Regulatory Status

Discontinued

1998
13 Apr
Discontinued Application: 74976

Drug Name

ACYCLOVIR

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

1998-04-13

74976 / 1

Active Ingredient

ACYCLOVIR

Application Number

74976

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

1998-04-13

Regulatory Status

Discontinued

1998
13 Apr
Discontinued Application: 74976

Drug Name

ACYCLOVIR

Product Number

2

Dosage Form

-

Strength

800MG

Approval Date

1998-04-13

74976 / 2

Active Ingredient

ACYCLOVIR

Application Number

74976

Product Number

2

Dosage Form

-

Strength

800MG

Approval Date

1998-04-13

Regulatory Status

Discontinued

1998
13 Apr
Discontinued Application: 74977

Drug Name

ACYCLOVIR

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1998-04-13

74977 / 1

Active Ingredient

ACYCLOVIR

Application Number

74977

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1998-04-13

Regulatory Status

Discontinued

2008
04 Aug
Discontinued Application: 78638

Drug Name

ALENDRONATE SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 35MG BASE

Approval Date

2008-08-04

78638 / 1

Active Ingredient

ALENDRONATE SODIUM

Application Number

78638

Product Number

1

Dosage Form

-

Strength

EQ 35MG BASE

Approval Date

2008-08-04

Regulatory Status

Discontinued

2008
04 Aug
Discontinued Application: 78638

Drug Name

ALENDRONATE SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 70MG BASE

Approval Date

2008-08-04

78638 / 2

Active Ingredient

ALENDRONATE SODIUM

Application Number

78638

Product Number

2

Dosage Form

-

Strength

EQ 70MG BASE

Approval Date

2008-08-04

Regulatory Status

Discontinued

1994
27 Jan
Discontinued Application: 74215

Drug Name

ALPRAZOLAM

Product Number

1

Dosage Form

-

Strength

0.25MG

Approval Date

1994-01-27

74215 / 1

Active Ingredient

ALPRAZOLAM

Application Number

74215

Product Number

1

Dosage Form

-

Strength

0.25MG

Approval Date

1994-01-27

Regulatory Status

Discontinued

1994
27 Jan
Discontinued Application: 74215

Drug Name

ALPRAZOLAM

Product Number

2

Dosage Form

-

Strength

0.5MG

Approval Date

1994-01-27

74215 / 2

Active Ingredient

ALPRAZOLAM

Application Number

74215

Product Number

2

Dosage Form

-

Strength

0.5MG

Approval Date

1994-01-27

Regulatory Status

Discontinued

1994
27 Jan
Discontinued Application: 74215

Drug Name

ALPRAZOLAM

Product Number

3

Dosage Form

-

Strength

1MG

Approval Date

1994-01-27

74215 / 3

Active Ingredient

ALPRAZOLAM

Application Number

74215

Product Number

3

Dosage Form

-

Strength

1MG

Approval Date

1994-01-27

Regulatory Status

Discontinued

1994
27 Jan
Discontinued Application: 74215

Drug Name

ALPRAZOLAM

Product Number

4

Dosage Form

-

Strength

2MG

Approval Date

1994-01-27

74215 / 4

Active Ingredient

ALPRAZOLAM

Application Number

74215

Product Number

4

Dosage Form

-

Strength

2MG

Approval Date

1994-01-27

Regulatory Status

Discontinued

2005
03 Oct
Discontinued Application: 76418

Drug Name

AMLODIPINE BESYLATE

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2005-10-03

76418 / 1

Active Ingredient

AMLODIPINE BESYLATE

Application Number

76418

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2005-10-03

Regulatory Status

Discontinued

2005
03 Oct
Discontinued Application: 76418

Drug Name

AMLODIPINE BESYLATE

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2005-10-03

76418 / 2

Active Ingredient

AMLODIPINE BESYLATE

Application Number

76418

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2005-10-03

Regulatory Status

Discontinued

2005
03 Oct
Discontinued Application: 76418

Drug Name

AMLODIPINE BESYLATE

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2005-10-03

76418 / 3

Active Ingredient

AMLODIPINE BESYLATE

Application Number

76418

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2005-10-03

Regulatory Status

Discontinued

2013
29 Nov
Discontinued Application: 200465

Drug Name

AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE;EQ 10MG BASE

Approval Date

2013-11-29

200465 / 1

Active Ingredient

AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM

Application Number

200465

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE;EQ 10MG BASE

Approval Date

2013-11-29

Regulatory Status

Discontinued

2013
29 Nov
Discontinued Application: 200465

Drug Name

AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM

Product Number

2

Dosage Form

-

Strength

EQ 2.5MG BASE;EQ 20MG BASE

Approval Date

2013-11-29

200465 / 2

Active Ingredient

AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM

Application Number

200465

Product Number

2

Dosage Form

-

Strength

EQ 2.5MG BASE;EQ 20MG BASE

Approval Date

2013-11-29

Regulatory Status

Discontinued

2013
29 Nov
Discontinued Application: 200465

Drug Name

AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM

Product Number

3

Dosage Form

-

Strength

EQ 2.5MG BASE;EQ 40MG BASE

Approval Date

2013-11-29

200465 / 3

Active Ingredient

AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM

Application Number

200465

Product Number

3

Dosage Form

-

Strength

EQ 2.5MG BASE;EQ 40MG BASE

Approval Date

2013-11-29

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 62067

Drug Name

AMOXICILLIN

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1982-01-01

62067 / 1

Active Ingredient

AMOXICILLIN

Application Number

62067

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 62067

Drug Name

AMOXICILLIN

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

62067 / 2

Active Ingredient

AMOXICILLIN

Application Number

62067

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 62090

Drug Name

AMOXICILLIN

Product Number

1

Dosage Form

-

Strength

125MG/5ML

Approval Date

1982-01-01

62090 / 1

Active Ingredient

AMOXICILLIN

Application Number

62090

Product Number

1

Dosage Form

-

Strength

125MG/5ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 62090

Drug Name

AMOXICILLIN

Product Number

2

Dosage Form

-

Strength

250MG/5ML

Approval Date

1982-01-01

62090 / 2

Active Ingredient

AMOXICILLIN

Application Number

62090

Product Number

2

Dosage Form

-

Strength

250MG/5ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 61755

Drug Name

AMPICILLIN TRIHYDRATE

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1982-01-01

61755 / 1

Active Ingredient

AMPICILLIN/AMPICILLIN TRIHYDRATE

Application Number

61755

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 61755

Drug Name

AMPICILLIN TRIHYDRATE

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1982-01-01

61755 / 2

Active Ingredient

AMPICILLIN/AMPICILLIN TRIHYDRATE

Application Number

61755

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 61829

Drug Name

AMPICILLIN TRIHYDRATE

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE/5ML

Approval Date

1982-01-01

61829 / 1

Active Ingredient

AMPICILLIN/AMPICILLIN TRIHYDRATE

Application Number

61829

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE/5ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 61829

Drug Name

AMPICILLIN TRIHYDRATE

Product Number

2

Dosage Form

-

Strength

EQ 125MG BASE/5ML

Approval Date

1982-01-01

61829 / 2

Active Ingredient

AMPICILLIN/AMPICILLIN TRIHYDRATE

Application Number

61829

Product Number

2

Dosage Form

-

Strength

EQ 125MG BASE/5ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

2019
23 Dec
Discontinued Application: 210128

Drug Name

APIXABAN

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2019-12-23

210128 / 1

Active Ingredient

APIXABAN

Application Number

210128

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2019-12-23

Regulatory Status

Discontinued

2019
23 Dec
Discontinued Application: 210128

Drug Name

APIXABAN

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2019-12-23

210128 / 2

Active Ingredient

APIXABAN

Application Number

210128

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2019-12-23

Regulatory Status

Discontinued

2026
05 Mar
Discontinued Application: 218851

Drug Name

APREPITANT

Product Number

1

Dosage Form

-

Strength

32MG/4.4ML (7.2MG/ML)

Approval Date

2026-03-05

218851 / 1

Active Ingredient

APREPITANT

Application Number

218851

Product Number

1

Dosage Form

-

Strength

32MG/4.4ML (7.2MG/ML)

Approval Date

2026-03-05

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17364

Drug Name

AQUATENSEN

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

17364 / 1

Active Ingredient

METHYCLOTHIAZIDE

Application Number

17364

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2024
03 Dec
Discontinued Application: 216608

Drug Name

ARIPIPRAZOLE

Product Number

1

Dosage Form

-

Strength

300MG/VIAL

Approval Date

2024-12-03

216608 / 1

Active Ingredient

ARIPIPRAZOLE

Application Number

216608

Product Number

1

Dosage Form

-

Strength

300MG/VIAL

Approval Date

2024-12-03

Regulatory Status

Discontinued

2024
03 Dec
Discontinued Application: 216608

Drug Name

ARIPIPRAZOLE

Product Number

2

Dosage Form

-

Strength

400MG/VIAL

Approval Date

2024-12-03

216608 / 2

Active Ingredient

ARIPIPRAZOLE

Application Number

216608

Product Number

2

Dosage Form

-

Strength

400MG/VIAL

Approval Date

2024-12-03

Regulatory Status

Discontinued

2008
15 Oct
Discontinued Application: 22203

Drug Name

ASTEPRO

Product Number

1

Dosage Form

-

Strength

0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2008-10-15

22203 / 1

Active Ingredient

AZELASTINE HYDROCHLORIDE

Application Number

22203

Product Number

1

Dosage Form

-

Strength

0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2008-10-15

Regulatory Status

Discontinued

2009
31 Aug
Discontinued Application: 22203

Drug Name

ASTEPRO

Product Number

2

Dosage Form

-

Strength

0.2055MG/SPRAY

Approval Date

2009-08-31

22203 / 2

Active Ingredient

AZELASTINE HYDROCHLORIDE

Application Number

22203

Product Number

2

Dosage Form

-

Strength

0.2055MG/SPRAY

Approval Date

2009-08-31

Regulatory Status

Discontinued

2018
24 Sep
Discontinued Application: 208177

Drug Name

ATAZANAVIR SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2018-09-24

208177 / 1

Active Ingredient

ATAZANAVIR SULFATE

Application Number

208177

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2018-09-24

Regulatory Status

Discontinued

2018
24 Sep
Discontinued Application: 208177

Drug Name

ATAZANAVIR SULFATE

Product Number

2

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2018-09-24

208177 / 2

Active Ingredient

ATAZANAVIR SULFATE

Application Number

208177

Product Number

2

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2018-09-24

Regulatory Status

Discontinued

2018
24 Sep
Discontinued Application: 208177

Drug Name

ATAZANAVIR SULFATE

Product Number

3

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

2018-09-24

208177 / 3

Active Ingredient

ATAZANAVIR SULFATE

Application Number

208177

Product Number

3

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

2018-09-24

Regulatory Status

Discontinued

1994
23 Mar
Discontinued Application: 74126

Drug Name

ATENOLOL

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1994-03-23

74126 / 1

Active Ingredient

ATENOLOL

Application Number

74126

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1994-03-23

Regulatory Status

Discontinued

1994
23 Mar
Discontinued Application: 74126

Drug Name

ATENOLOL

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

1994-03-23

74126 / 2

Active Ingredient

ATENOLOL

Application Number

74126

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

1994-03-23

Regulatory Status

Discontinued

1998
26 Aug
Discontinued Application: 74126

Drug Name

ATENOLOL

Product Number

3

Dosage Form

-

Strength

25MG

Approval Date

1998-08-26

74126 / 3

Active Ingredient

ATENOLOL

Application Number

74126

Product Number

3

Dosage Form

-

Strength

25MG

Approval Date

1998-08-26

Regulatory Status

Discontinued

2004
11 Feb
Discontinued Application: 76612

Drug Name

BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

5MG;6.25MG

Approval Date

2004-02-11

76612 / 1

Active Ingredient

BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

Application Number

76612

Product Number

1

Dosage Form

-

Strength

5MG;6.25MG

Approval Date

2004-02-11

Regulatory Status

Discontinued

2004
11 Feb
Discontinued Application: 76612

Drug Name

BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

10MG;12.5MG

Approval Date

2004-02-11

76612 / 2

Active Ingredient

BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

Application Number

76612

Product Number

2

Dosage Form

-

Strength

10MG;12.5MG

Approval Date

2004-02-11

Regulatory Status

Discontinued

2004
11 Feb
Discontinued Application: 76612

Drug Name

BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

Product Number

3

Dosage Form

-

Strength

20MG;12.5MG

Approval Date

2004-02-11

76612 / 3

Active Ingredient

BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

Application Number

76612

Product Number

3

Dosage Form

-

Strength

20MG;12.5MG

Approval Date

2004-02-11

Regulatory Status

Discontinued

2004
11 Feb
Discontinued Application: 76612

Drug Name

BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

Product Number

4

Dosage Form

-

Strength

20MG;25MG

Approval Date

2004-02-11

76612 / 4

Active Ingredient

BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

Application Number

76612

Product Number

4

Dosage Form

-

Strength

20MG;25MG

Approval Date

2004-02-11

Regulatory Status

Discontinued

1990
28 Dec
Discontinued Application: 19001

Drug Name

BEPADIN

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1990-12-28

19001 / 1

Active Ingredient

BEPRIDIL HYDROCHLORIDE

Application Number

19001

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1990-12-28

Regulatory Status

Discontinued

1990
28 Dec
Discontinued Application: 19001

Drug Name

BEPADIN

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

1990-12-28

19001 / 2

Active Ingredient

BEPRIDIL HYDROCHLORIDE

Application Number

19001

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

1990-12-28

Regulatory Status

Discontinued

1990
28 Dec
Discontinued Application: 19001

Drug Name

BEPADIN

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

1990-12-28

19001 / 3

Active Ingredient

BEPRIDIL HYDROCHLORIDE

Application Number

19001

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

1990-12-28

Regulatory Status

Discontinued

2020
15 Jan
Discontinued Application: 205173

Drug Name

BOSENTAN

Product Number

1

Dosage Form

-

Strength

62.5MG

Approval Date

2020-01-15

205173 / 1

Active Ingredient

BOSENTAN

Application Number

205173

Product Number

1

Dosage Form

-

Strength

62.5MG

Approval Date

2020-01-15

Regulatory Status

Discontinued

2020
15 Jan
Discontinued Application: 205173

Drug Name

BOSENTAN

Product Number

2

Dosage Form

-

Strength

125MG

Approval Date

2020-01-15

205173 / 2

Active Ingredient

BOSENTAN

Application Number

205173

Product Number

2

Dosage Form

-

Strength

125MG

Approval Date

2020-01-15

Regulatory Status

Discontinued

2002
28 Feb
Discontinued Application: 75467

Drug Name

BUSPIRONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2002-02-28

75467 / 1

Active Ingredient

BUSPIRONE HYDROCHLORIDE

Application Number

75467

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2002-02-28

Regulatory Status

Discontinued

2001
28 Mar
Discontinued Application: 75467

Drug Name

BUSPIRONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

7.5MG

Approval Date

2001-03-28

75467 / 2

Active Ingredient

BUSPIRONE HYDROCHLORIDE

Application Number

75467

Product Number

2

Dosage Form

-

Strength

7.5MG

Approval Date

2001-03-28

Regulatory Status

Discontinued

2002
28 Feb
Discontinued Application: 75467

Drug Name

BUSPIRONE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2002-02-28

75467 / 3

Active Ingredient

BUSPIRONE HYDROCHLORIDE

Application Number

75467

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2002-02-28

Regulatory Status

Discontinued

2002
28 Feb
Discontinued Application: 75467

Drug Name

BUSPIRONE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

15MG

Approval Date

2002-02-28

75467 / 4

Active Ingredient

BUSPIRONE HYDROCHLORIDE

Application Number

75467

Product Number

4

Dosage Form

-

Strength

15MG

Approval Date

2002-02-28

Regulatory Status

Discontinued

2013
08 Jul
Discontinued Application: 76008

Drug Name

BUSPIRONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

7.5MG

Approval Date

2013-07-08

76008 / 2

Active Ingredient

BUSPIRONE HYDROCHLORIDE

Application Number

76008

Product Number

2

Dosage Form

-

Strength

7.5MG

Approval Date

2013-07-08

Regulatory Status

Discontinued

2017
20 Nov
Discontinued Application: 208536

Drug Name

BUSULFAN

Product Number

1

Dosage Form

-

Strength

6MG/ML

Approval Date

2017-11-20

208536 / 1

Active Ingredient

BUSULFAN

Application Number

208536

Product Number

1

Dosage Form

-

Strength

6MG/ML

Approval Date

2017-11-20

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85381

Drug Name

BUTICAPS

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

1982-01-01

85381 / 1

Active Ingredient

BUTABARBITAL SODIUM

Application Number

85381

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85381

Drug Name

BUTICAPS

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

1982-01-01

85381 / 2

Active Ingredient

BUTABARBITAL SODIUM

Application Number

85381

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85381

Drug Name

BUTICAPS

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

85381 / 3

Active Ingredient

BUTABARBITAL SODIUM

Application Number

85381

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85381

Drug Name

BUTICAPS

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

85381 / 4

Active Ingredient

BUTABARBITAL SODIUM

Application Number

85381

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2023
05 Jul
Discontinued Application: 207381

Drug Name

CABAZITAXEL

Product Number

1

Dosage Form

-

Strength

60MG/1.5ML (40MG/ML)

Approval Date

2023-07-05

207381 / 1

Active Ingredient

CABAZITAXEL

Application Number

207381

Product Number

1

Dosage Form

-

Strength

60MG/1.5ML (40MG/ML)

Approval Date

2023-07-05

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84601

Drug Name

CHLORDIAZEPOXIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

84601 / 1

Active Ingredient

CHLORDIAZEPOXIDE HYDROCHLORIDE

Application Number

84601

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84886

Drug Name

CHLORDIAZEPOXIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

84886 / 1

Active Ingredient

CHLORDIAZEPOXIDE HYDROCHLORIDE

Application Number

84886

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84887

Drug Name

CHLORDIAZEPOXIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

84887 / 1

Active Ingredient

CHLORDIAZEPOXIDE HYDROCHLORIDE

Application Number

84887

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2007
18 Sep
Discontinued Application: 78567

Drug Name

CICLOPIROX

Product Number

1

Dosage Form

-

Strength

8%

Approval Date

2007-09-18

78567 / 1

Active Ingredient

CICLOPIROX

Application Number

78567

Product Number

1

Dosage Form

-

Strength

8%

Approval Date

2007-09-18

Regulatory Status

Discontinued

2010
15 Apr
Discontinued Application: 75417

Drug Name

CLOZAPINE

Product Number

3

Dosage Form

-

Strength

12.5MG

Approval Date

2010-04-15

75417 / 3

Active Ingredient

CLOZAPINE

Application Number

75417

Product Number

3

Dosage Form

-

Strength

12.5MG

Approval Date

2010-04-15

Regulatory Status

Discontinued

2024
07 Feb
Discontinued Application: 209986

Drug Name

COBICISTAT

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2024-02-07

209986 / 1

Active Ingredient

COBICISTAT

Application Number

209986

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2024-02-07

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85735

Drug Name

COLONAID

Product Number

1

Dosage Form

-

Strength

0.025MG/5ML;2.5MG/5ML

Approval Date

1982-01-01

85735 / 1

Active Ingredient

ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE

Application Number

85735

Product Number

1

Dosage Form

-

Strength

0.025MG/5ML;2.5MG/5ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85737

Drug Name

COLONAID

Product Number

1

Dosage Form

-

Strength

0.025MG;2.5MG

Approval Date

1982-01-01

85737 / 1

Active Ingredient

ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE

Application Number

85737

Product Number

1

Dosage Form

-

Strength

0.025MG;2.5MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2003
23 Sep
Discontinued Application: 40451

Drug Name

CYANOCOBALAMIN

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2003-09-23

40451 / 1

Active Ingredient

CYANOCOBALAMIN

Application Number

40451

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2003-09-23

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 86678

Drug Name

CYPROHEPTADINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

4MG

Approval Date

1982-01-01

86678 / 1

Active Ingredient

CYPROHEPTADINE HYDROCHLORIDE

Application Number

86678

Product Number

1

Dosage Form

-

Strength

4MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 8762

Drug Name

DILANTIN-30

Product Number

2

Dosage Form

-

Strength

30MG/5ML

Approval Date

1982-01-01

Active Ingredient

PHENYTOIN

Application Number

8762

Product Number

2

Dosage Form

-

Strength

30MG/5ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1999
30 Sep
Discontinued Application: 75375

Drug Name

DILTIAZEM HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG/ML

Approval Date

1999-09-30

75375 / 1

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

75375

Product Number

1

Dosage Form

-

Strength

5MG/ML

Approval Date

1999-09-30

Regulatory Status

Discontinued

2020
17 Aug
Discontinued Application: 210531

Drug Name

DIMETHYL FUMARATE

Product Number

1

Dosage Form

-

Strength

120MG

Approval Date

2020-08-17

210531 / 1

Active Ingredient

DIMETHYL FUMARATE

Application Number

210531

Product Number

1

Dosage Form

-

Strength

120MG

Approval Date

2020-08-17

Regulatory Status

Discontinued

2020
17 Aug
Discontinued Application: 210531

Drug Name

DIMETHYL FUMARATE

Product Number

2

Dosage Form

-

Strength

240MG

Approval Date

2020-08-17

210531 / 2

Active Ingredient

DIMETHYL FUMARATE

Application Number

210531

Product Number

2

Dosage Form

-

Strength

240MG

Approval Date

2020-08-17

Regulatory Status

Discontinued

2002
29 Nov
Discontinued Application: 76185

Drug Name

DIMETHYL SULFOXIDE

Product Number

1

Dosage Form

-

Strength

50%

Approval Date

2002-11-29

76185 / 1

Active Ingredient

DIMETHYL SULFOXIDE

Application Number

76185

Product Number

1

Dosage Form

-

Strength

50%

Approval Date

2002-11-29

Regulatory Status

Discontinued

1985
14 Jun
Discontinued Application: 70138

Drug Name

DISOPYRAMIDE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

1985-06-14

70138 / 1

Active Ingredient

DISOPYRAMIDE PHOSPHATE

Application Number

70138

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

1985-06-14

Regulatory Status

Discontinued

1985
14 Jun
Discontinued Application: 70139

Drug Name

DISOPYRAMIDE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

1985-06-14

70139 / 1

Active Ingredient

DISOPYRAMIDE PHOSPHATE

Application Number

70139

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

1985-06-14

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 12708

Drug Name

DIUTENSEN-R

Product Number

5

Dosage Form

-

Strength

2.5MG;0.1MG

Approval Date

1982-01-01

12708 / 5

Active Ingredient

METHYCLOTHIAZIDE; RESERPINE

Application Number

12708

Product Number

5

Dosage Form

-

Strength

2.5MG;0.1MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2008
29 Jul
Discontinued Application: 77254

Drug Name

DIVALPROEX SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 125MG VALPROIC ACID

Approval Date

2008-07-29

77254 / 1

Active Ingredient

DIVALPROEX SODIUM

Application Number

77254

Product Number

1

Dosage Form

-

Strength

EQ 125MG VALPROIC ACID

Approval Date

2008-07-29

Regulatory Status

Discontinued

2008
29 Jul
Discontinued Application: 77254

Drug Name

DIVALPROEX SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 250MG VALPROIC ACID

Approval Date

2008-07-29

77254 / 2

Active Ingredient

DIVALPROEX SODIUM

Application Number

77254

Product Number

2

Dosage Form

-

Strength

EQ 250MG VALPROIC ACID

Approval Date

2008-07-29

Regulatory Status

Discontinued

2008
29 Jul
Discontinued Application: 77254

Drug Name

DIVALPROEX SODIUM

Product Number

3

Dosage Form

-

Strength

EQ 500MG VALPROIC ACID

Approval Date

2008-07-29

77254 / 3

Active Ingredient

DIVALPROEX SODIUM

Application Number

77254

Product Number

3

Dosage Form

-

Strength

EQ 500MG VALPROIC ACID

Approval Date

2008-07-29

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17374

Drug Name

DORMATE

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

1982-01-01

17374 / 1

Active Ingredient

MEBUTAMATE

Application Number

17374

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2011
28 Oct
Discontinued Application: 200170

Drug Name

DOXORUBICIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG/VIAL

Approval Date

2011-10-28

200170 / 1

Active Ingredient

DOXORUBICIN HYDROCHLORIDE

Application Number

200170

Product Number

1

Dosage Form

-

Strength

10MG/VIAL

Approval Date

2011-10-28

Regulatory Status

Discontinued

1983
15 Feb
Discontinued Application: 62432

Drug Name

DOXYCYCLINE HYCLATE

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

1983-02-15

62432 / 1

Active Ingredient

DOXYCYCLINE HYCLATE

Application Number

62432

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

1983-02-15

Regulatory Status

Discontinued

1999
27 Apr
Discontinued Application: 20615

Drug Name

DURACLON

Product Number

2

Dosage Form

-

Strength

5MG/10ML (0.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1999-04-27

20615 / 2

Active Ingredient

CLONIDINE HYDROCHLORIDE

Application Number

20615

Product Number

2

Dosage Form

-

Strength

5MG/10ML (0.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1999-04-27

Regulatory Status

Discontinued

2016
17 Feb
Discontinued Application: 91471

Drug Name

EFAVIRENZ

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2016-02-17

91471 / 1

Active Ingredient

EFAVIRENZ

Application Number

91471

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2016-02-17

Regulatory Status

Discontinued

2024
05 Sep
Discontinued Application: 209061

Drug Name

EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Product Number

1

Dosage Form

-

Strength

600MG;200MG;300MG

Approval Date

2024-09-05

209061 / 1

Active Ingredient

EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Application Number

209061

Product Number

1

Dosage Form

-

Strength

600MG;200MG;300MG

Approval Date

2024-09-05

Regulatory Status

Discontinued

2000
22 Aug
Discontinued Application: 75472

Drug Name

ENALAPRIL MALEATE

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2000-08-22

75472 / 1

Active Ingredient

ENALAPRIL MALEATE

Application Number

75472

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2000-08-22

Regulatory Status

Discontinued

2000
22 Aug
Discontinued Application: 75472

Drug Name

ENALAPRIL MALEATE

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2000-08-22

75472 / 2

Active Ingredient

ENALAPRIL MALEATE

Application Number

75472

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2000-08-22

Regulatory Status

Discontinued

2000
22 Aug
Discontinued Application: 75472

Drug Name

ENALAPRIL MALEATE

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2000-08-22

75472 / 3

Active Ingredient

ENALAPRIL MALEATE

Application Number

75472

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2000-08-22

Regulatory Status

Discontinued

2000
22 Aug
Discontinued Application: 75472

Drug Name

ENALAPRIL MALEATE

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2000-08-22

75472 / 4

Active Ingredient

ENALAPRIL MALEATE

Application Number

75472

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2000-08-22

Regulatory Status

Discontinued

1995
03 Aug
Discontinued Application: 19430

Drug Name

EPI E Z PEN JR

Product Number

4

Dosage Form

-

Strength

0.15MG/DELIVERY

Approval Date

1995-08-03

19430 / 4

Active Ingredient

EPINEPHRINE

Application Number

19430

Product Number

4

Dosage Form

-

Strength

0.15MG/DELIVERY

Approval Date

1995-08-03

Regulatory Status

Discontinued

1995
03 Aug
Discontinued Application: 19430

Drug Name

EPIPEN E Z PEN

Product Number

3

Dosage Form

-

Strength

0.3MG/DELIVERY

Approval Date

1995-08-03

19430 / 3

Active Ingredient

EPINEPHRINE

Application Number

19430

Product Number

3

Dosage Form

-

Strength

0.3MG/DELIVERY

Approval Date

1995-08-03

Regulatory Status

Discontinued

1987
21 Oct
Discontinued Application: 50617

Drug Name

ERYGEL

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1987-10-21

50617 / 1

Active Ingredient

ERYTHROMYCIN

Application Number

50617

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1987-10-21

Regulatory Status

Discontinued

2020
25 Jun
Discontinued Application: 212088

Drug Name

ESOMEPRAZOLE MAGNESIUM

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2020-06-25

212088 / 1

Active Ingredient

ESOMEPRAZOLE MAGNESIUM

Application Number

212088

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2020-06-25

Regulatory Status

Discontinued

2016
23 Aug
Discontinued Application: 204634

Drug Name

ETHACRYNATE SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/VIAL

Approval Date

2016-08-23

204634 / 1

Active Ingredient

ETHACRYNATE SODIUM

Application Number

204634

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/VIAL

Approval Date

2016-08-23

Regulatory Status

Discontinued

1998
30 Sep
Discontinued Application: 75012

Drug Name

ETODOLAC

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

1998-09-30

75012 / 1

Active Ingredient

ETODOLAC

Application Number

75012

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

1998-09-30

Regulatory Status

Discontinued

1998
30 Sep
Discontinued Application: 75012

Drug Name

ETODOLAC

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

1998-09-30

75012 / 2

Active Ingredient

ETODOLAC

Application Number

75012

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

1998-09-30

Regulatory Status

Discontinued

1998
30 Sep
Discontinued Application: 75071

Drug Name

ETODOLAC

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1998-09-30

75071 / 1

Active Ingredient

ETODOLAC

Application Number

75071

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1998-09-30

Regulatory Status

Discontinued

1998
30 Sep
Discontinued Application: 75071

Drug Name

ETODOLAC

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

1998-09-30

75071 / 2

Active Ingredient

ETODOLAC

Application Number

75071

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

1998-09-30

Regulatory Status

Discontinued

2019
19 Apr
Discontinued Application: 210130

Drug Name

EVEROLIMUS

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2019-04-19

210130 / 1

Active Ingredient

EVEROLIMUS

Application Number

210130

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2019-04-19

Regulatory Status

Discontinued

2019
19 Apr
Discontinued Application: 210130

Drug Name

EVEROLIMUS

Product Number

2

Dosage Form

-

Strength

3MG

Approval Date

2019-04-19

210130 / 2

Active Ingredient

EVEROLIMUS

Application Number

210130

Product Number

2

Dosage Form

-

Strength

3MG

Approval Date

2019-04-19

Regulatory Status

Discontinued

2019
19 Apr
Discontinued Application: 210130

Drug Name

EVEROLIMUS

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

2019-04-19

210130 / 3

Active Ingredient

EVEROLIMUS

Application Number

210130

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

2019-04-19

Regulatory Status

Discontinued

2020
08 Jun
Discontinued Application: 212936

Drug Name

EVEROLIMUS

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2020-06-08

212936 / 1

Active Ingredient

EVEROLIMUS

Application Number

212936

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2020-06-08

Regulatory Status

Discontinued

2020
08 Jun
Discontinued Application: 212936

Drug Name

EVEROLIMUS

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2020-06-08

212936 / 2

Active Ingredient

EVEROLIMUS

Application Number

212936

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2020-06-08

Regulatory Status

Discontinued

2020
08 Jun
Discontinued Application: 212936

Drug Name

EVEROLIMUS

Product Number

3

Dosage Form

-

Strength

7.5MG

Approval Date

2020-06-08

212936 / 3

Active Ingredient

EVEROLIMUS

Application Number

212936

Product Number

3

Dosage Form

-

Strength

7.5MG

Approval Date

2020-06-08

Regulatory Status

Discontinued

2020
08 Jun
Discontinued Application: 212936

Drug Name

EVEROLIMUS

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2020-06-08

212936 / 4

Active Ingredient

EVEROLIMUS

Application Number

212936

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2020-06-08

Regulatory Status

Discontinued

1998
28 Dec
Discontinued Application: 40298

Drug Name

EXTENDED PHENYTOIN SODIUM

Product Number

1

Dosage Form

-

Strength

100MG EXTENDED

Approval Date

1998-12-28

40298 / 1

Active Ingredient

PHENYTOIN SODIUM

Application Number

40298

Product Number

1

Dosage Form

-

Strength

100MG EXTENDED

Approval Date

1998-12-28

Regulatory Status

Discontinued

2001
18 Apr
Discontinued Application: 75457

Drug Name

FAMOTIDINE

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2001-04-18

75457 / 1

Active Ingredient

FAMOTIDINE

Application Number

75457

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2001-04-18

Regulatory Status

Discontinued

2001
18 Apr
Discontinued Application: 75457

Drug Name

FAMOTIDINE

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

2001-04-18

75457 / 2

Active Ingredient

FAMOTIDINE

Application Number

75457

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

2001-04-18

Regulatory Status

Discontinued

1993
29 Jul
Discontinued Application: 20189

Drug Name

FELBATOL

Product Number

3

Dosage Form

-

Strength

600MG/5ML

Approval Date

1993-07-29

20189 / 3

Active Ingredient

FELBAMATE

Application Number

20189

Product Number

3

Dosage Form

-

Strength

600MG/5ML

Approval Date

1993-07-29

Regulatory Status

Discontinued

2008
17 Apr
Discontinued Application: 78855

Drug Name

FELODIPINE

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2008-04-17

78855 / 1

Active Ingredient

FELODIPINE

Application Number

78855

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2008-04-17

Regulatory Status

Discontinued

2008
17 Apr
Discontinued Application: 78855

Drug Name

FELODIPINE

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2008-04-17

78855 / 2

Active Ingredient

FELODIPINE

Application Number

78855

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2008-04-17

Regulatory Status

Discontinued

2008
17 Apr
Discontinued Application: 78855

Drug Name

FELODIPINE

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2008-04-17

78855 / 3

Active Ingredient

FELODIPINE

Application Number

78855

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2008-04-17

Regulatory Status

Discontinued

2007
25 Oct
Discontinued Application: 76520

Drug Name

FENOFIBRATE

Product Number

1

Dosage Form

-

Strength

54MG

Approval Date

2007-10-25

76520 / 1

Active Ingredient

FENOFIBRATE

Application Number

76520

Product Number

1

Dosage Form

-

Strength

54MG

Approval Date

2007-10-25

Regulatory Status

Discontinued

2005
29 Dec
Discontinued Application: 76520

Drug Name

FENOFIBRATE

Product Number

2

Dosage Form

-

Strength

107MG

Approval Date

2005-12-29

76520 / 2

Active Ingredient

FENOFIBRATE

Application Number

76520

Product Number

2

Dosage Form

-

Strength

107MG

Approval Date

2005-12-29

Regulatory Status

Discontinued

2007
25 Oct
Discontinued Application: 76520

Drug Name

FENOFIBRATE

Product Number

3

Dosage Form

-

Strength

160MG

Approval Date

2007-10-25

76520 / 3

Active Ingredient

FENOFIBRATE

Application Number

76520

Product Number

3

Dosage Form

-

Strength

160MG

Approval Date

2007-10-25

Regulatory Status

Discontinued

2006
18 Dec
Discontinued Application: 77578

Drug Name

FINASTERIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2006-12-18

77578 / 1

Active Ingredient

FINASTERIDE

Application Number

77578

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2006-12-18

Regulatory Status

Discontinued

2021
19 Jan
Discontinued Application: 208005

Drug Name

FINGOLIMOD HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE

Approval Date

2021-01-19

208005 / 1

Active Ingredient

FINGOLIMOD HYDROCHLORIDE

Application Number

208005

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE

Approval Date

2021-01-19

Regulatory Status

Discontinued

2004
29 Jul
Discontinued Application: 76042

Drug Name

FLUCONAZOLE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2004-07-29

76042 / 1

Active Ingredient

FLUCONAZOLE

Application Number

76042

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2004-07-29

Regulatory Status

Discontinued

2004
29 Jul
Discontinued Application: 76042

Drug Name

FLUCONAZOLE

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2004-07-29

76042 / 2

Active Ingredient

FLUCONAZOLE

Application Number

76042

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2004-07-29

Regulatory Status

Discontinued

2004
29 Jul
Discontinued Application: 76042

Drug Name

FLUCONAZOLE

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2004-07-29

76042 / 3

Active Ingredient

FLUCONAZOLE

Application Number

76042

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2004-07-29

Regulatory Status

Discontinued

2004
29 Jul
Discontinued Application: 76042

Drug Name

FLUCONAZOLE

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2004-07-29

76042 / 4

Active Ingredient

FLUCONAZOLE

Application Number

76042

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2004-07-29

Regulatory Status

Discontinued

2005
25 Mar
Discontinued Application: 76889

Drug Name

FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

200MG/100ML (2MG/ML)

Approval Date

2005-03-25

76889 / 1

Active Ingredient

FLUCONAZOLE

Application Number

76889

Product Number

1

Dosage Form

-

Strength

200MG/100ML (2MG/ML)

Approval Date

2005-03-25

Regulatory Status

Discontinued

2005
25 Mar
Discontinued Application: 76889

Drug Name

FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

400MG/200ML (2MG/ML)

Approval Date

2005-03-25

76889 / 2

Active Ingredient

FLUCONAZOLE

Application Number

76889

Product Number

2

Dosage Form

-

Strength

400MG/200ML (2MG/ML)

Approval Date

2005-03-25

Regulatory Status

Discontinued

2001
15 Oct
Discontinued Application: 75950

Drug Name

FLUVOXAMINE MALEATE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2001-10-15

75950 / 1

Active Ingredient

FLUVOXAMINE MALEATE

Application Number

75950

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2001-10-15

Regulatory Status

Discontinued

2001
15 Oct
Discontinued Application: 75950

Drug Name

FLUVOXAMINE MALEATE

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2001-10-15

75950 / 2

Active Ingredient

FLUVOXAMINE MALEATE

Application Number

75950

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2001-10-15

Regulatory Status

Discontinued

2009
07 Apr
Discontinued Application: 79033

Drug Name

FOMEPIZOLE

Product Number

1

Dosage Form

-

Strength

1.5GM/1.5ML (1GM/ML)

Approval Date

2009-04-07

79033 / 1

Active Ingredient

FOMEPIZOLE

Application Number

79033

Product Number

1

Dosage Form

-

Strength

1.5GM/1.5ML (1GM/ML)

Approval Date

2009-04-07

Regulatory Status

Discontinued

2019
05 Sep
Discontinued Application: 204015

Drug Name

FOSAPREPITANT DIMEGLUMINE

Product Number

1

Dosage Form

-

Strength

EQ 115MG BASE/VIAL

Approval Date

2019-09-05

204015 / 1

Active Ingredient

FOSAPREPITANT DIMEGLUMINE

Application Number

204015

Product Number

1

Dosage Form

-

Strength

EQ 115MG BASE/VIAL

Approval Date

2019-09-05

Regulatory Status

Discontinued

2006
14 Aug
Discontinued Application: 77705

Drug Name

FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

10MG;12.5MG

Approval Date

2006-08-14

77705 / 1

Active Ingredient

FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE

Application Number

77705

Product Number

1

Dosage Form

-

Strength

10MG;12.5MG

Approval Date

2006-08-14

Regulatory Status

Discontinued

2006
14 Aug
Discontinued Application: 77705

Drug Name

FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

20MG;12.5MG

Approval Date

2006-08-14

77705 / 2

Active Ingredient

FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE

Application Number

77705

Product Number

2

Dosage Form

-

Strength

20MG;12.5MG

Approval Date

2006-08-14

Regulatory Status

Discontinued

2009
29 May
Discontinued Application: 77590

Drug Name

GALANTAMINE HYDROBROMIDE

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2009-05-29

77590 / 1

Active Ingredient

GALANTAMINE HYDROBROMIDE

Application Number

77590

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2009-05-29

Regulatory Status

Discontinued

2009
29 May
Discontinued Application: 77590

Drug Name

GALANTAMINE HYDROBROMIDE

Product Number

2

Dosage Form

-

Strength

EQ 8MG BASE

Approval Date

2009-05-29

77590 / 2

Active Ingredient

GALANTAMINE HYDROBROMIDE

Application Number

77590

Product Number

2

Dosage Form

-

Strength

EQ 8MG BASE

Approval Date

2009-05-29

Regulatory Status

Discontinued

2009
29 May
Discontinued Application: 77590

Drug Name

GALANTAMINE HYDROBROMIDE

Product Number

3

Dosage Form

-

Strength

EQ 12MG BASE

Approval Date

2009-05-29

77590 / 3

Active Ingredient

GALANTAMINE HYDROBROMIDE

Application Number

77590

Product Number

3

Dosage Form

-

Strength

EQ 12MG BASE

Approval Date

2009-05-29

Regulatory Status

Discontinued

2006
10 Feb
Discontinued Application: 77486

Drug Name

GLIMEPIRIDE

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2006-02-10

77486 / 1

Active Ingredient

GLIMEPIRIDE

Application Number

77486

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2006-02-10

Regulatory Status

Discontinued

2006
10 Feb
Discontinued Application: 77486

Drug Name

GLIMEPIRIDE

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2006-02-10

77486 / 2

Active Ingredient

GLIMEPIRIDE

Application Number

77486

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2006-02-10

Regulatory Status

Discontinued

2006
10 Feb
Discontinued Application: 77486

Drug Name

GLIMEPIRIDE

Product Number

3

Dosage Form

-

Strength

4MG

Approval Date

2006-02-10

77486 / 3

Active Ingredient

GLIMEPIRIDE

Application Number

77486

Product Number

3

Dosage Form

-

Strength

4MG

Approval Date

2006-02-10

Regulatory Status

Discontinued

2009
16 Jul
Discontinued Application: 70278

Drug Name

HALOPERIDOL

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2009-07-16

70278 / 3

Active Ingredient

HALOPERIDOL

Application Number

70278

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2009-07-16

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 87085

Drug Name

HYDRALAZINE HYDROCHLORIDE-HYDROCHLOROTHIAZIDE-RESERPINE

Product Number

1

Dosage Form

-

Strength

25MG;15MG;0.1MG

Approval Date

1982-01-01

87085 / 1

Active Ingredient

HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE; RESERPINE

Application Number

87085

Product Number

1

Dosage Form

-

Strength

25MG;15MG;0.1MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84880

Drug Name

HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

84880 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE

Application Number

84880

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85112

Drug Name

HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

85112 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE

Application Number

85112

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 80134

Drug Name

HYZYD

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

80134 / 3

Active Ingredient

ISONIAZID

Application Number

80134

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 80134

Drug Name

HYZYD

Product Number

4

Dosage Form

-

Strength

300MG

Approval Date

1982-01-01

80134 / 4

Active Ingredient

ISONIAZID

Application Number

80134

Product Number

4

Dosage Form

-

Strength

300MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2010
11 Jan
Discontinued Application: 90924

Drug Name

IBUTILIDE FUMARATE

Product Number

1

Dosage Form

-

Strength

0.1MG/ML

Approval Date

2010-01-11

90924 / 1

Active Ingredient

IBUTILIDE FUMARATE

Application Number

90924

Product Number

1

Dosage Form

-

Strength

0.1MG/ML

Approval Date

2010-01-11

Regulatory Status

Discontinued

2014
20 Mar
Discontinued Application: 202139

Drug Name

INDOMETHACIN

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

2014-03-20

202139 / 1

Active Ingredient

INDOMETHACIN

Application Number

202139

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

2014-03-20

Regulatory Status

Discontinued

2012
20 Jul
Discontinued Application: 200463

Drug Name

ITRACONAZOLE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2012-07-20

200463 / 1

Active Ingredient

ITRACONAZOLE

Application Number

200463

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2012-07-20

Regulatory Status

Discontinued

2002
20 Feb
Discontinued Application: 75679

Drug Name

KETOPROFEN

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

2002-02-20

75679 / 2

Active Ingredient

KETOPROFEN

Application Number

75679

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

2002-02-20

Regulatory Status

Discontinued

2002
20 Feb
Discontinued Application: 75679

Drug Name

KETOPROFEN

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2002-02-20

75679 / 3

Active Ingredient

KETOPROFEN

Application Number

75679

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2002-02-20

Regulatory Status

Discontinued

2016
01 Jun
Discontinued Application: 203187

Drug Name

LANSOPRAZOLE

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2016-06-01

203187 / 1

Active Ingredient

LANSOPRAZOLE

Application Number

203187

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2016-06-01

Regulatory Status

Discontinued

2008
04 Nov
Discontinued Application: 76919

Drug Name

LEVETIRACETAM

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2008-11-04

76919 / 1

Active Ingredient

LEVETIRACETAM

Application Number

76919

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2008-11-04

Regulatory Status

Discontinued

2009
10 Feb
Discontinued Application: 78731

Drug Name

LEVETIRACETAM

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2009-02-10

78731 / 1

Active Ingredient

LEVETIRACETAM

Application Number

78731

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2009-02-10

Regulatory Status

Discontinued

2009
10 Feb
Discontinued Application: 78731

Drug Name

LEVETIRACETAM

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2009-02-10

78731 / 2

Active Ingredient

LEVETIRACETAM

Application Number

78731

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2009-02-10

Regulatory Status

Discontinued

2009
10 Feb
Discontinued Application: 78731

Drug Name

LEVETIRACETAM

Product Number

3

Dosage Form

-

Strength

750MG

Approval Date

2009-02-10

78731 / 3

Active Ingredient

LEVETIRACETAM

Application Number

78731

Product Number

3

Dosage Form

-

Strength

750MG

Approval Date

2009-02-10

Regulatory Status

Discontinued

2009
10 Feb
Discontinued Application: 78731

Drug Name

LEVETIRACETAM

Product Number

4

Dosage Form

-

Strength

1GM

Approval Date

2009-02-10

78731 / 4

Active Ingredient

LEVETIRACETAM

Application Number

78731

Product Number

4

Dosage Form

-

Strength

1GM

Approval Date

2009-02-10

Regulatory Status

Discontinued

2021
09 Feb
Discontinued Application: 209564

Drug Name

LINACLOTIDE

Product Number

1

Dosage Form

-

Strength

145MCG

Approval Date

2021-02-09

209564 / 1

Active Ingredient

LINACLOTIDE

Application Number

209564

Product Number

1

Dosage Form

-

Strength

145MCG

Approval Date

2021-02-09

Regulatory Status

Discontinued

2021
09 Feb
Discontinued Application: 209564

Drug Name

LINACLOTIDE

Product Number

2

Dosage Form

-

Strength

290MCG

Approval Date

2021-02-09

209564 / 2

Active Ingredient

LINACLOTIDE

Application Number

209564

Product Number

2

Dosage Form

-

Strength

290MCG

Approval Date

2021-02-09

Regulatory Status

Discontinued

2010
06 Oct
Discontinued Application: 91590

Drug Name

LOSARTAN POTASSIUM

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2010-10-06

91590 / 1

Active Ingredient

LOSARTAN POTASSIUM

Application Number

91590

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2010-10-06

Regulatory Status

Discontinued

2010
06 Oct
Discontinued Application: 91590

Drug Name

LOSARTAN POTASSIUM

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2010-10-06

91590 / 2

Active Ingredient

LOSARTAN POTASSIUM

Application Number

91590

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2010-10-06

Regulatory Status

Discontinued

2010
06 Oct
Discontinued Application: 91590

Drug Name

LOSARTAN POTASSIUM

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2010-10-06

91590 / 3

Active Ingredient

LOSARTAN POTASSIUM

Application Number

91590

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2010-10-06

Regulatory Status

Discontinued

2010
06 Oct
Discontinued Application: 91652

Drug Name

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

12.5MG;50MG

Approval Date

2010-10-06

91652 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM

Application Number

91652

Product Number

1

Dosage Form

-

Strength

12.5MG;50MG

Approval Date

2010-10-06

Regulatory Status

Discontinued

2010
06 Apr
Discontinued Application: 91652

Drug Name

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

12.5MG;100MG

Approval Date

2010-04-06

91652 / 2

Active Ingredient

HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM

Application Number

91652

Product Number

2

Dosage Form

-

Strength

12.5MG;100MG

Approval Date

2010-04-06

Regulatory Status

Discontinued

2010
06 Oct
Discontinued Application: 91652

Drug Name

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

Product Number

3

Dosage Form

-

Strength

25MG;100MG

Approval Date

2010-10-06

91652 / 3

Active Ingredient

HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM

Application Number

91652

Product Number

3

Dosage Form

-

Strength

25MG;100MG

Approval Date

2010-10-06

Regulatory Status

Discontinued

2018
14 Sep
Discontinued Application: 209911

Drug Name

MAGNESIUM SULFATE IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

2GM/50ML (40MG/ML)

Approval Date

2018-09-14

209911 / 1

Active Ingredient

MAGNESIUM SULFATE

Application Number

209911

Product Number

1

Dosage Form

-

Strength

2GM/50ML (40MG/ML)

Approval Date

2018-09-14

Regulatory Status

Discontinued

2018
14 Sep
Discontinued Application: 209911

Drug Name

MAGNESIUM SULFATE IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

4GM/100ML (40MG/ML)

Approval Date

2018-09-14

209911 / 2

Active Ingredient

MAGNESIUM SULFATE

Application Number

209911

Product Number

2

Dosage Form

-

Strength

4GM/100ML (40MG/ML)

Approval Date

2018-09-14

Regulatory Status

Discontinued

2006
20 Jul
Discontinued Application: 77934

Drug Name

MELOXICAM

Product Number

1

Dosage Form

-

Strength

7.5MG

Approval Date

2006-07-20

77934 / 1

Active Ingredient

MELOXICAM

Application Number

77934

Product Number

1

Dosage Form

-

Strength

7.5MG

Approval Date

2006-07-20

Regulatory Status

Discontinued

2006
20 Jul
Discontinued Application: 77934

Drug Name

MELOXICAM

Product Number

2

Dosage Form

-

Strength

15MG

Approval Date

2006-07-20

77934 / 2

Active Ingredient

MELOXICAM

Application Number

77934

Product Number

2

Dosage Form

-

Strength

15MG

Approval Date

2006-07-20

Regulatory Status

Discontinued

2009
27 Oct
Discontinued Application: 90299

Drug Name

MELPHALAN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/VIAL

Approval Date

2009-10-27

90299 / 1

Active Ingredient

MELPHALAN HYDROCHLORIDE

Application Number

90299

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/VIAL

Approval Date

2009-10-27

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83618

Drug Name

MEPROBAMATE

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

1982-01-01

83618 / 1

Active Ingredient

MEPROBAMATE

Application Number

83618

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 11284

Drug Name

MEPROSPAN

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1982-01-01

11284 / 1

Active Ingredient

MEPROBAMATE

Application Number

11284

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 11284

Drug Name

MEPROSPAN

Product Number

2

Dosage Form

-

Strength

400MG

Approval Date

1982-01-01

11284 / 2

Active Ingredient

MEPROBAMATE

Application Number

11284

Product Number

2

Dosage Form

-

Strength

400MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2005
01 Jul
Discontinued Application: 40594

Drug Name

MERCAPTOPURINE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2005-07-01

40594 / 1

Active Ingredient

MERCAPTOPURINE

Application Number

40594

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2005-07-01

Regulatory Status

Discontinued

2018
20 Nov
Discontinued Application: 203574

Drug Name

MESALAMINE

Product Number

1

Dosage Form

-

Strength

1.2GM

Approval Date

2018-11-20

203574 / 1

Active Ingredient

MESALAMINE

Application Number

203574

Product Number

1

Dosage Form

-

Strength

1.2GM

Approval Date

2018-11-20

Regulatory Status

Discontinued

2012
08 Mar
Discontinued Application: 76488

Drug Name

MESNA

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2012-03-08

76488 / 1

Active Ingredient

MESNA

Application Number

76488

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2012-03-08

Regulatory Status

Discontinued

1987
17 Aug
Discontinued Application: 70804

Drug Name

METAPROTERENOL SULFATE

Product Number

1

Dosage Form

-

Strength

0.6%

Approval Date

1987-08-17

70804 / 1

Active Ingredient

METAPROTERENOL SULFATE

Application Number

70804

Product Number

1

Dosage Form

-

Strength

0.6%

Approval Date

1987-08-17

Regulatory Status

Discontinued

1988
05 Aug
Discontinued Application: 71786

Drug Name

METAPROTERENOL SULFATE

Product Number

1

Dosage Form

-

Strength

0.4%

Approval Date

1988-08-05

71786 / 1

Active Ingredient

METAPROTERENOL SULFATE

Application Number

71786

Product Number

1

Dosage Form

-

Strength

0.4%

Approval Date

1988-08-05

Regulatory Status

Discontinued

2001
07 Jun
Discontinued Application: 40350

Drug Name

METHIMAZOLE

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2001-06-07

40350 / 3

Active Ingredient

METHIMAZOLE

Application Number

40350

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2001-06-07

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84259

Drug Name

METHOCARBAMOL

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

84259 / 1

Active Ingredient

METHOCARBAMOL

Application Number

84259

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84323

Drug Name

METHOCARBAMOL

Product Number

1

Dosage Form

-

Strength

750MG

Approval Date

1982-01-01

84323 / 1

Active Ingredient

METHOCARBAMOL

Application Number

84323

Product Number

1

Dosage Form

-

Strength

750MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
17 Aug
Discontinued Application: 87671

Drug Name

METHYCLOTHIAZIDE

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

1982-08-17

87671 / 1

Active Ingredient

METHYCLOTHIAZIDE

Application Number

87671

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

1982-08-17

Regulatory Status

Discontinued

2025
28 May
Discontinued Application: 208592

Drug Name

METHYLNALTREXONE BROMIDE

Product Number

1

Dosage Form

-

Strength

12MG/0.6ML (12MG/0.6ML)

Approval Date

2025-05-28

208592 / 1

Active Ingredient

METHYLNALTREXONE BROMIDE

Application Number

208592

Product Number

1

Dosage Form

-

Strength

12MG/0.6ML (12MG/0.6ML)

Approval Date

2025-05-28

Regulatory Status

Discontinued

2011
15 Dec
Discontinued Application: 202033

Drug Name

METOPROLOL SUCCINATE

Product Number

1

Dosage Form

-

Strength

EQ 25MG TARTRATE

Approval Date

2011-12-15

202033 / 1

Active Ingredient

METOPROLOL SUCCINATE

Application Number

202033

Product Number

1

Dosage Form

-

Strength

EQ 25MG TARTRATE

Approval Date

2011-12-15

Regulatory Status

Discontinued

2011
15 Dec
Discontinued Application: 202033

Drug Name

METOPROLOL SUCCINATE

Product Number

2

Dosage Form

-

Strength

EQ 50MG TARTRATE

Approval Date

2011-12-15

202033 / 2

Active Ingredient

METOPROLOL SUCCINATE

Application Number

202033

Product Number

2

Dosage Form

-

Strength

EQ 50MG TARTRATE

Approval Date

2011-12-15

Regulatory Status

Discontinued

2011
15 Dec
Discontinued Application: 202033

Drug Name

METOPROLOL SUCCINATE

Product Number

3

Dosage Form

-

Strength

EQ 100MG TARTRATE

Approval Date

2011-12-15

202033 / 3

Active Ingredient

METOPROLOL SUCCINATE

Application Number

202033

Product Number

3

Dosage Form

-

Strength

EQ 100MG TARTRATE

Approval Date

2011-12-15

Regulatory Status

Discontinued

2011
15 Dec
Discontinued Application: 202033

Drug Name

METOPROLOL SUCCINATE

Product Number

4

Dosage Form

-

Strength

EQ 200MG TARTRATE

Approval Date

2011-12-15

202033 / 4

Active Ingredient

METOPROLOL SUCCINATE

Application Number

202033

Product Number

4

Dosage Form

-

Strength

EQ 200MG TARTRATE

Approval Date

2011-12-15

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84978

Drug Name

MICRAININ

Product Number

1

Dosage Form

-

Strength

325MG;200MG

Approval Date

1982-01-01

84978 / 1

Active Ingredient

ASPIRIN; MEPROBAMATE

Application Number

84978

Product Number

1

Dosage Form

-

Strength

325MG;200MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 11045

Drug Name

MILPREM-200

Product Number

2

Dosage Form

-

Strength

0.45MG;200MG

Approval Date

1982-01-01

11045 / 2

Active Ingredient

ESTROGENS, CONJUGATED; MEPROBAMATE

Application Number

11045

Product Number

2

Dosage Form

-

Strength

0.45MG;200MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 11045

Drug Name

MILPREM-400

Product Number

1

Dosage Form

-

Strength

0.45MG;400MG

Approval Date

1982-01-01

11045 / 1

Active Ingredient

ESTROGENS, CONJUGATED; MEPROBAMATE

Application Number

11045

Product Number

1

Dosage Form

-

Strength

0.45MG;400MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2003
16 Jun
Discontinued Application: 76428

Drug Name

MILRINONE LACTATE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2003-06-16

76428 / 1

Active Ingredient

MILRINONE LACTATE

Application Number

76428

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2003-06-16

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 9698

Drug Name

MILTOWN

Product Number

2

Dosage Form

-

Strength

400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Active Ingredient

MEPROBAMATE

Application Number

9698

Product Number

2

Dosage Form

-

Strength

400MG **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: 9698

Drug Name

MILTOWN

Product Number

4

Dosage Form

-

Strength

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

Approval Date

1982-01-01

Active Ingredient

MEPROBAMATE

Application Number

9698

Product Number

4

Dosage Form

-

Strength

200MG **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: 83919

Drug Name

MILTOWN

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

1982-01-01

83919 / 1

Active Ingredient

MEPROBAMATE

Application Number

83919

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1996
19 Nov
Discontinued Application: 20700

Drug Name

MUSE

Product Number

1

Dosage Form

-

Strength

0.125MG

Approval Date

1996-11-19

20700 / 1

Active Ingredient

ALPROSTADIL

Application Number

20700

Product Number

1

Dosage Form

-

Strength

0.125MG

Approval Date

1996-11-19

Regulatory Status

Discontinued

1996
19 Nov
Discontinued Application: 20700

Drug Name

MUSE

Product Number

2

Dosage Form

-

Strength

0.25MG

Approval Date

1996-11-19

20700 / 2

Active Ingredient

ALPROSTADIL

Application Number

20700

Product Number

2

Dosage Form

-

Strength

0.25MG

Approval Date

1996-11-19

Regulatory Status

Discontinued

1996
19 Nov
Discontinued Application: 20700

Drug Name

MUSE

Product Number

3

Dosage Form

-

Strength

0.5MG

Approval Date

1996-11-19

20700 / 3

Active Ingredient

ALPROSTADIL

Application Number

20700

Product Number

3

Dosage Form

-

Strength

0.5MG

Approval Date

1996-11-19

Regulatory Status

Discontinued

1996
19 Nov
Discontinued Application: 20700

Drug Name

MUSE

Product Number

4

Dosage Form

-

Strength

1MG

Approval Date

1996-11-19

20700 / 4

Active Ingredient

ALPROSTADIL

Application Number

20700

Product Number

4

Dosage Form

-

Strength

1MG

Approval Date

1996-11-19

Regulatory Status

Discontinued

1985
28 Jun
Discontinued Application: 60572

Drug Name

MYCOLOG-II

Product Number

1

Dosage Form

-

Strength

100,000 UNITS/GM;0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1985-06-28

60572 / 1

Active Ingredient

NYSTATIN; TRIAMCINOLONE ACETONIDE

Application Number

60572

Product Number

1

Dosage Form

-

Strength

100,000 UNITS/GM;0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1985-06-28

Regulatory Status

Discontinued

1985
15 May
Discontinued Application: 62606

Drug Name

MYCOLOG-II

Product Number

1

Dosage Form

-

Strength

100,000 UNITS/GM;0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons*

Approval Date

1985-05-15

62606 / 1

Active Ingredient

NYSTATIN; TRIAMCINOLONE ACETONIDE

Application Number

62606

Product Number

1

Dosage Form

-

Strength

100,000 UNITS/GM;0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons*

Approval Date

1985-05-15

Regulatory Status

Discontinued

2009
04 May
Discontinued Application: 65520

Drug Name

MYCOPHENOLATE MOFETIL

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2009-05-04

65520 / 1

Active Ingredient

MYCOPHENOLATE MOFETIL

Application Number

65520

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2009-05-04

Regulatory Status

Discontinued

2009
04 May
Discontinued Application: 65521

Drug Name

MYCOPHENOLATE MOFETIL

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2009-05-04

65521 / 1

Active Ingredient

MYCOPHENOLATE MOFETIL

Application Number

65521

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2009-05-04

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 9789

Drug Name

MYLAXEN

Product Number

3

Dosage Form

-

Strength

20MG/ML

Approval Date

1982-01-01

Active Ingredient

HEXAFLUORENIUM BROMIDE

Application Number

9789

Product Number

3

Dosage Form

-

Strength

20MG/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 80059

Drug Name

NEOPASALATE

Product Number

2

Dosage Form

-

Strength

846MG;112MG

Approval Date

1982-01-01

80059 / 2

Active Ingredient

AMINOSALICYLATE SODIUM; AMINOSALICYLIC ACID

Application Number

80059

Product Number

2

Dosage Form

-

Strength

846MG;112MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2008
25 Jul
Discontinued Application: 79051

Drug Name

NISOLDIPINE

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2008-07-25

79051 / 1

Active Ingredient

NISOLDIPINE

Application Number

79051

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2008-07-25

Regulatory Status

Discontinued

2008
25 Jul
Discontinued Application: 79051

Drug Name

NISOLDIPINE

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2008-07-25

79051 / 2

Active Ingredient

NISOLDIPINE

Application Number

79051

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2008-07-25

Regulatory Status

Discontinued

2008
25 Jul
Discontinued Application: 79051

Drug Name

NISOLDIPINE

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2008-07-25

79051 / 3

Active Ingredient

NISOLDIPINE

Application Number

79051

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2008-07-25

Regulatory Status

Discontinued

2011
26 Jan
Discontinued Application: 91001

Drug Name

NISOLDIPINE

Product Number

1

Dosage Form

-

Strength

8.5MG

Approval Date

2011-01-26

91001 / 1

Active Ingredient

NISOLDIPINE

Application Number

91001

Product Number

1

Dosage Form

-

Strength

8.5MG

Approval Date

2011-01-26

Regulatory Status

Discontinued

2011
26 Jan
Discontinued Application: 91001

Drug Name

NISOLDIPINE

Product Number

2

Dosage Form

-

Strength

17MG

Approval Date

2011-01-26

91001 / 2

Active Ingredient

NISOLDIPINE

Application Number

91001

Product Number

2

Dosage Form

-

Strength

17MG

Approval Date

2011-01-26

Regulatory Status

Discontinued

2011
26 Jan
Discontinued Application: 91001

Drug Name

NISOLDIPINE

Product Number

3

Dosage Form

-

Strength

25.5MG

Approval Date

2011-01-26

91001 / 3

Active Ingredient

NISOLDIPINE

Application Number

91001

Product Number

3

Dosage Form

-

Strength

25.5MG

Approval Date

2011-01-26

Regulatory Status

Discontinued

2011
26 Jan
Discontinued Application: 91001

Drug Name

NISOLDIPINE

Product Number

4

Dosage Form

-

Strength

34MG

Approval Date

2011-01-26

91001 / 4

Active Ingredient

NISOLDIPINE

Application Number

91001

Product Number

4

Dosage Form

-

Strength

34MG

Approval Date

2011-01-26

Regulatory Status

Discontinued

1999
12 Nov
Discontinued Application: 74992

Drug Name

NITROGLYCERIN

Product Number

1

Dosage Form

-

Strength

0.6MG/HR

Approval Date

1999-11-12

74992 / 1

Active Ingredient

NITROGLYCERIN

Application Number

74992

Product Number

1

Dosage Form

-

Strength

0.6MG/HR

Approval Date

1999-11-12

Regulatory Status

Discontinued

1999
12 Nov
Discontinued Application: 74992

Drug Name

NITROGLYCERIN

Product Number

2

Dosage Form

-

Strength

0.4MG/HR

Approval Date

1999-11-12

74992 / 2

Active Ingredient

NITROGLYCERIN

Application Number

74992

Product Number

2

Dosage Form

-

Strength

0.4MG/HR

Approval Date

1999-11-12

Regulatory Status

Discontinued

1999
12 Nov
Discontinued Application: 74992

Drug Name

NITROGLYCERIN

Product Number

3

Dosage Form

-

Strength

0.2MG/HR

Approval Date

1999-11-12

74992 / 3

Active Ingredient

NITROGLYCERIN

Application Number

74992

Product Number

3

Dosage Form

-

Strength

0.2MG/HR

Approval Date

1999-11-12

Regulatory Status

Discontinued

1999
12 Nov
Discontinued Application: 74992

Drug Name

NITROGLYCERIN

Product Number

4

Dosage Form

-

Strength

0.1MG/HR

Approval Date

1999-11-12

74992 / 4

Active Ingredient

NITROGLYCERIN

Application Number

74992

Product Number

4

Dosage Form

-

Strength

0.1MG/HR

Approval Date

1999-11-12

Regulatory Status

Discontinued

2002
09 Jul
Discontinued Application: 75934

Drug Name

NIZATIDINE

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2002-07-09

75934 / 1

Active Ingredient

NIZATIDINE

Application Number

75934

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2002-07-09

Regulatory Status

Discontinued

2002
09 Jul
Discontinued Application: 75934

Drug Name

NIZATIDINE

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2002-07-09

75934 / 2

Active Ingredient

NIZATIDINE

Application Number

75934

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2002-07-09

Regulatory Status

Discontinued

2015
28 Dec
Discontinued Application: 200486

Drug Name

NORETHINDRONE AND ETHINYL ESTRADIOL

Product Number

1

Dosage Form

-

Strength

0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG

Approval Date

2015-12-28

200486 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORETHINDRONE

Application Number

200486

Product Number

1

Dosage Form

-

Strength

0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG

Approval Date

2015-12-28

Regulatory Status

Discontinued

2015
21 Oct
Discontinued Application: 200488

Drug Name

NORETHINDRONE AND ETHINYL ESTRADIOL

Product Number

1

Dosage Form

-

Strength

0.035MG;0.5MG

Approval Date

2015-10-21

200488 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORETHINDRONE

Application Number

200488

Product Number

1

Dosage Form

-

Strength

0.035MG;0.5MG

Approval Date

2015-10-21

Regulatory Status

Discontinued

2015
21 Oct
Discontinued Application: 200489

Drug Name

NORETHINDRONE AND ETHINYL ESTRADIOL

Product Number

1

Dosage Form

-

Strength

0.035MG;1MG

Approval Date

2015-10-21

200489 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORETHINDRONE

Application Number

200489

Product Number

1

Dosage Form

-

Strength

0.035MG;1MG

Approval Date

2015-10-21

Regulatory Status

Discontinued

2016
27 Jan
Discontinued Application: 201896

Drug Name

NORGESTIMATE AND ETHINYL ESTRADIOL

Product Number

1

Dosage Form

-

Strength

0.035MG;0.25MG

Approval Date

2016-01-27

201896 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORGESTIMATE

Application Number

201896

Product Number

1

Dosage Form

-

Strength

0.035MG;0.25MG

Approval Date

2016-01-27

Regulatory Status

Discontinued

2016
21 Jun
Discontinued Application: 201828

Drug Name

NORGESTREL AND ETHINYL ESTRADIOL

Product Number

1

Dosage Form

-

Strength

0.03MG;0.3MG

Approval Date

2016-06-21

201828 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORGESTREL

Application Number

201828

Product Number

1

Dosage Form

-

Strength

0.03MG;0.3MG

Approval Date

2016-06-21

Regulatory Status

Discontinued

2017
08 May
Discontinued Application: 202875

Drug Name

NORGESTREL AND ETHINYL ESTRADIOL

Product Number

1

Dosage Form

-

Strength

0.05MG;0.5MG

Approval Date

2017-05-08

202875 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORGESTREL

Application Number

202875

Product Number

1

Dosage Form

-

Strength

0.05MG;0.5MG

Approval Date

2017-05-08

Regulatory Status

Discontinued

2017
14 Nov
Discontinued Application: 91358

Drug Name

OXALIPLATIN

Product Number

3

Dosage Form

-

Strength

200MG/40ML (5MG/ML)

Approval Date

2017-11-14

91358 / 3

Active Ingredient

OXALIPLATIN

Application Number

91358

Product Number

3

Dosage Form

-

Strength

200MG/40ML (5MG/ML)

Approval Date

2017-11-14

Regulatory Status

Discontinued

2001
28 Feb
Discontinued Application: 75847

Drug Name

OXAPROZIN

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2001-02-28

75847 / 1

Active Ingredient

OXAPROZIN

Application Number

75847

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2001-02-28

Regulatory Status

Discontinued

1987
20 Oct
Discontinued Application: 71713

Drug Name

OXAZEPAM

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1987-10-20

71713 / 1

Active Ingredient

OXAZEPAM

Application Number

71713

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1987-10-20

Regulatory Status

Discontinued

1987
20 Oct
Discontinued Application: 71714

Drug Name

OXAZEPAM

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

1987-10-20

71714 / 1

Active Ingredient

OXAZEPAM

Application Number

71714

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

1987-10-20

Regulatory Status

Discontinued

1987
20 Oct
Discontinued Application: 71715

Drug Name

OXAZEPAM

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

1987-10-20

71715 / 1

Active Ingredient

OXAZEPAM

Application Number

71715

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

1987-10-20

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 60752

Drug Name

PENICILLIN G POTASSIUM

Product Number

1

Dosage Form

-

Strength

400,000 UNITS/5ML

Approval Date

1982-01-01

60752 / 1

Active Ingredient

PENICILLIN G POTASSIUM

Application Number

60752

Product Number

1

Dosage Form

-

Strength

400,000 UNITS/5ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 60752

Drug Name

PENICILLIN G POTASSIUM

Product Number

2

Dosage Form

-

Strength

250,000 UNITS/5ML

Approval Date

1982-01-01

60752 / 2

Active Ingredient

PENICILLIN G POTASSIUM

Application Number

60752

Product Number

2

Dosage Form

-

Strength

250,000 UNITS/5ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 60752

Drug Name

PENICILLIN G POTASSIUM

Product Number

3

Dosage Form

-

Strength

200,000 UNITS/5ML

Approval Date

1982-01-01

60752 / 3

Active Ingredient

PENICILLIN G POTASSIUM

Application Number

60752

Product Number

3

Dosage Form

-

Strength

200,000 UNITS/5ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 60781

Drug Name

PENICILLIN G POTASSIUM

Product Number

1

Dosage Form

-

Strength

200,000 UNITS

Approval Date

1982-01-01

60781 / 1

Active Ingredient

PENICILLIN G POTASSIUM

Application Number

60781

Product Number

1

Dosage Form

-

Strength

200,000 UNITS

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 60781

Drug Name

PENICILLIN G POTASSIUM

Product Number

2

Dosage Form

-

Strength

250,000 UNITS

Approval Date

1982-01-01

60781 / 2

Active Ingredient

PENICILLIN G POTASSIUM

Application Number

60781

Product Number

2

Dosage Form

-

Strength

250,000 UNITS

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 60781

Drug Name

PENICILLIN G POTASSIUM

Product Number

3

Dosage Form

-

Strength

400,000 UNITS

Approval Date

1982-01-01

60781 / 3

Active Ingredient

PENICILLIN G POTASSIUM

Application Number

60781

Product Number

3

Dosage Form

-

Strength

400,000 UNITS

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 60781

Drug Name

PENICILLIN G POTASSIUM

Product Number

4

Dosage Form

-

Strength

800,000 UNITS

Approval Date

1982-01-01

60781 / 4

Active Ingredient

PENICILLIN G POTASSIUM

Application Number

60781

Product Number

4

Dosage Form

-

Strength

800,000 UNITS

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 60781

Drug Name

PENICILLIN G POTASSIUM

Product Number

5

Dosage Form

-

Strength

500,000 UNITS

Approval Date

1982-01-01

60781 / 5

Active Ingredient

PENICILLIN G POTASSIUM

Application Number

60781

Product Number

5

Dosage Form

-

Strength

500,000 UNITS

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 61530

Drug Name

PENICILLIN V POTASSIUM

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1982-01-01

61530 / 1

Active Ingredient

PENICILLIN V POTASSIUM

Application Number

61530

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 61530

Drug Name

PENICILLIN V POTASSIUM

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1982-01-01

61530 / 2

Active Ingredient

PENICILLIN V POTASSIUM

Application Number

61530

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 61624

Drug Name

PENICILLIN V POTASSIUM

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE/5ML

Approval Date

1982-01-01

61624 / 1

Active Ingredient

PENICILLIN V POTASSIUM

Application Number

61624

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE/5ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 61624

Drug Name

PENICILLIN V POTASSIUM

Product Number

2

Dosage Form

-

Strength

EQ 125MG BASE/5ML

Approval Date

1982-01-01

61624 / 2

Active Ingredient

PENICILLIN V POTASSIUM

Application Number

61624

Product Number

2

Dosage Form

-

Strength

EQ 125MG BASE/5ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

2017
14 Apr
Discontinued Application: 206691

Drug Name

PERPHENAZINE

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2017-04-14

206691 / 1

Active Ingredient

PERPHENAZINE

Application Number

206691

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2017-04-14

Regulatory Status

Discontinued

2017
14 Apr
Discontinued Application: 206691

Drug Name

PERPHENAZINE

Product Number

2

Dosage Form

-

Strength

4MG

Approval Date

2017-04-14

206691 / 2

Active Ingredient

PERPHENAZINE

Application Number

206691

Product Number

2

Dosage Form

-

Strength

4MG

Approval Date

2017-04-14

Regulatory Status

Discontinued

2017
14 Apr
Discontinued Application: 206691

Drug Name

PERPHENAZINE

Product Number

3

Dosage Form

-

Strength

8MG

Approval Date

2017-04-14

206691 / 3

Active Ingredient

PERPHENAZINE

Application Number

206691

Product Number

3

Dosage Form

-

Strength

8MG

Approval Date

2017-04-14

Regulatory Status

Discontinued

2017
14 Apr
Discontinued Application: 206691

Drug Name

PERPHENAZINE

Product Number

4

Dosage Form

-

Strength

16MG

Approval Date

2017-04-14

206691 / 4

Active Ingredient

PERPHENAZINE

Application Number

206691

Product Number

4

Dosage Form

-

Strength

16MG

Approval Date

2017-04-14

Regulatory Status

Discontinued

1992
24 Sep
Discontinued Application: 74013

Drug Name

PINDOLOL

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1992-09-24

74013 / 1

Active Ingredient

PINDOLOL

Application Number

74013

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1992-09-24

Regulatory Status

Discontinued

1992
24 Sep
Discontinued Application: 74018

Drug Name

PINDOLOL

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1992-09-24

74018 / 1

Active Ingredient

PINDOLOL

Application Number

74018

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1992-09-24

Regulatory Status

Discontinued

1992
22 Sep
Discontinued Application: 74043

Drug Name

PIROXICAM

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1992-09-22

74043 / 1

Active Ingredient

PIROXICAM

Application Number

74043

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1992-09-22

Regulatory Status

Discontinued

1992
22 Sep
Discontinued Application: 74043

Drug Name

PIROXICAM

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

1992-09-22

74043 / 2

Active Ingredient

PIROXICAM

Application Number

74043

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

1992-09-22

Regulatory Status

Discontinued

2022
26 Jan
Discontinued Application: 210275

Drug Name

POMALIDOMIDE

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2022-01-26

210275 / 1

Active Ingredient

POMALIDOMIDE

Application Number

210275

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2022-01-26

Regulatory Status

Discontinued

2022
26 Jan
Discontinued Application: 210275

Drug Name

POMALIDOMIDE

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2022-01-26

210275 / 2

Active Ingredient

POMALIDOMIDE

Application Number

210275

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2022-01-26

Regulatory Status

Discontinued

2022
26 Jan
Discontinued Application: 210275

Drug Name

POMALIDOMIDE

Product Number

3

Dosage Form

-

Strength

3MG

Approval Date

2022-01-26

210275 / 3

Active Ingredient

POMALIDOMIDE

Application Number

210275

Product Number

3

Dosage Form

-

Strength

3MG

Approval Date

2022-01-26

Regulatory Status

Discontinued

2022
26 Jan
Discontinued Application: 210275

Drug Name

POMALIDOMIDE

Product Number

4

Dosage Form

-

Strength

4MG

Approval Date

2022-01-26

210275 / 4

Active Ingredient

POMALIDOMIDE

Application Number

210275

Product Number

4

Dosage Form

-

Strength

4MG

Approval Date

2022-01-26

Regulatory Status

Discontinued

2002
21 Nov
Discontinued Application: 40471

Drug Name

PROMETHAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG/ML

Approval Date

2002-11-21

40471 / 1

Active Ingredient

PROMETHAZINE HYDROCHLORIDE

Application Number

40471

Product Number

1

Dosage Form

-

Strength

25MG/ML

Approval Date

2002-11-21

Regulatory Status

Discontinued

2016
29 Apr
Discontinued Application: 203803

Drug Name

PROPAFENONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

225MG

Approval Date

2016-04-29

203803 / 1

Active Ingredient

PROPAFENONE HYDROCHLORIDE

Application Number

203803

Product Number

1

Dosage Form

-

Strength

225MG

Approval Date

2016-04-29

Regulatory Status

Discontinued

2016
29 Apr
Discontinued Application: 203803

Drug Name

PROPAFENONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

325MG

Approval Date

2016-04-29

203803 / 2

Active Ingredient

PROPAFENONE HYDROCHLORIDE

Application Number

203803

Product Number

2

Dosage Form

-

Strength

325MG

Approval Date

2016-04-29

Regulatory Status

Discontinued

2016
29 Apr
Discontinued Application: 203803

Drug Name

PROPAFENONE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

425MG

Approval Date

2016-04-29

203803 / 3

Active Ingredient

PROPAFENONE HYDROCHLORIDE

Application Number

203803

Product Number

3

Dosage Form

-

Strength

425MG

Approval Date

2016-04-29

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83706

Drug Name

PROPANTHELINE BROMIDE

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

1982-01-01

83706 / 1

Active Ingredient

PROPANTHELINE BROMIDE

Application Number

83706

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2004
16 Dec
Discontinued Application: 40569

Drug Name

PROPOXYPHENE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

65MG

Approval Date

2004-12-16

40569 / 1

Active Ingredient

PROPOXYPHENE HYDROCHLORIDE

Application Number

40569

Product Number

1

Dosage Form

-

Strength

65MG

Approval Date

2004-12-16

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83299

Drug Name

PROPOXYPHENE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

65MG

Approval Date

1982-01-01

83299 / 1

Active Ingredient

PROPOXYPHENE HYDROCHLORIDE

Application Number

83299

Product Number

1

Dosage Form

-

Strength

65MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83528

Drug Name

PROPOXYPHENE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

32MG

Approval Date

1982-01-01

83528 / 1

Active Ingredient

PROPOXYPHENE HYDROCHLORIDE

Application Number

83528

Product Number

1

Dosage Form

-

Strength

32MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83689

Drug Name

PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG;32MG

Approval Date

1982-01-01

83689 / 1

Active Ingredient

ACETAMINOPHEN; PROPOXYPHENE HYDROCHLORIDE

Application Number

83689

Product Number

1

Dosage Form

-

Strength

325MG;32MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 83978

Drug Name

PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

650MG;65MG

Approval Date

1982-01-01

83978 / 1

Active Ingredient

ACETAMINOPHEN; PROPOXYPHENE HYDROCHLORIDE

Application Number

83978

Product Number

1

Dosage Form

-

Strength

650MG;65MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1985
12 Jun
Discontinued Application: 70145

Drug Name

PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

650MG;100MG

Approval Date

1985-06-12

70145 / 1

Active Ingredient

ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE

Application Number

70145

Product Number

1

Dosage Form

-

Strength

650MG;100MG

Approval Date

1985-06-12

Regulatory Status

Discontinued

1988
16 Feb
Discontinued Application: 72195

Drug Name

PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

650MG;100MG

Approval Date

1988-02-16

72195 / 1

Active Ingredient

ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE

Application Number

72195

Product Number

1

Dosage Form

-

Strength

650MG;100MG

Approval Date

1988-02-16

Regulatory Status

Discontinued

1989
09 Jun
Discontinued Application: 72275

Drug Name

PROPRANOLOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

1989-06-09

72275 / 1

Active Ingredient

PROPRANOLOL HYDROCHLORIDE

Application Number

72275

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

1989-06-09

Regulatory Status

Discontinued

2016
14 Jul
Discontinued Application: 204879

Drug Name

PYRIDOXINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2016-07-14

204879 / 1

Active Ingredient

PYRIDOXINE HYDROCHLORIDE

Application Number

204879

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2016-07-14

Regulatory Status

Discontinued

2005
28 Jan
Discontinued Application: 76036

Drug Name

QUINAPRIL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2005-01-28

76036 / 1

Active Ingredient

QUINAPRIL HYDROCHLORIDE

Application Number

76036

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2005-01-28

Regulatory Status

Discontinued

2005
28 Jan
Discontinued Application: 76036

Drug Name

QUINAPRIL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2005-01-28

76036 / 2

Active Ingredient

QUINAPRIL HYDROCHLORIDE

Application Number

76036

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2005-01-28

Regulatory Status

Discontinued

2005
28 Jan
Discontinued Application: 76036

Drug Name

QUINAPRIL HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2005-01-28

76036 / 3

Active Ingredient

QUINAPRIL HYDROCHLORIDE

Application Number

76036

Product Number

3

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2005-01-28

Regulatory Status

Discontinued

2005
28 Jan
Discontinued Application: 76036

Drug Name

QUINAPRIL HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2005-01-28

76036 / 4

Active Ingredient

QUINAPRIL HYDROCHLORIDE

Application Number

76036

Product Number

4

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2005-01-28

Regulatory Status

Discontinued

1997
22 Aug
Discontinued Application: 74023

Drug Name

RANITIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

1997-08-22

74023 / 1

Active Ingredient

RANITIDINE HYDROCHLORIDE

Application Number

74023

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

1997-08-22

Regulatory Status

Discontinued

1997
22 Aug
Discontinued Application: 74023

Drug Name

RANITIDINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

1997-08-22

74023 / 2

Active Ingredient

RANITIDINE HYDROCHLORIDE

Application Number

74023

Product Number

2

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

1997-08-22

Regulatory Status

Discontinued

2016
09 Jun
Discontinued Application: 79076

Drug Name

RANITIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE/ML

Approval Date

2016-06-09

79076 / 1

Active Ingredient

RANITIDINE HYDROCHLORIDE

Application Number

79076

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE/ML

Approval Date

2016-06-09

Regulatory Status

Discontinued

2023
04 Apr
Discontinued Application: 213856

Drug Name

REGADENOSON

Product Number

1

Dosage Form

-

Strength

0.4MG/5ML (0.08MG/ML)

Approval Date

2023-04-04

213856 / 1

Active Ingredient

REGADENOSON

Application Number

213856

Product Number

1

Dosage Form

-

Strength

0.4MG/5ML (0.08MG/ML)

Approval Date

2023-04-04

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84974

Drug Name

RESERPINE

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

1982-01-01

84974 / 1

Active Ingredient

RESERPINE

Application Number

84974

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2012
30 Aug
Discontinued Application: 203109

Drug Name

REVATIO

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

2012-08-30

203109 / 1

Active Ingredient

SILDENAFIL CITRATE

Application Number

203109

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

2012-08-30

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 60641

Drug Name

RONDOMYCIN

Product Number

1

Dosage Form

-

Strength

EQ 140MG BASE

Approval Date

1982-01-01

60641 / 1

Active Ingredient

METHACYCLINE HYDROCHLORIDE

Application Number

60641

Product Number

1

Dosage Form

-

Strength

EQ 140MG BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 60641

Drug Name

RONDOMYCIN

Product Number

2

Dosage Form

-

Strength

EQ 280MG BASE

Approval Date

1982-01-01

60641 / 2

Active Ingredient

METHACYCLINE HYDROCHLORIDE

Application Number

60641

Product Number

2

Dosage Form

-

Strength

EQ 280MG BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 60641

Drug Name

RONDOMYCIN

Product Number

3

Dosage Form

-

Strength

EQ 70MG BASE/5ML

Approval Date

1982-01-01

60641 / 3

Active Ingredient

METHACYCLINE HYDROCHLORIDE

Application Number

60641

Product Number

3

Dosage Form

-

Strength

EQ 70MG BASE/5ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

2007
20 Mar
Discontinued Application: 76540

Drug Name

SERTRALINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2007-03-20

76540 / 1

Active Ingredient

SERTRALINE HYDROCHLORIDE

Application Number

76540

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2007-03-20

Regulatory Status

Discontinued

2007
20 Mar
Discontinued Application: 76540

Drug Name

SERTRALINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2007-03-20

76540 / 2

Active Ingredient

SERTRALINE HYDROCHLORIDE

Application Number

76540

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2007-03-20

Regulatory Status

Discontinued

2007
20 Mar
Discontinued Application: 76540

Drug Name

SERTRALINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2007-03-20

76540 / 3

Active Ingredient

SERTRALINE HYDROCHLORIDE

Application Number

76540

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2007-03-20

Regulatory Status

Discontinued

2012
09 Nov
Discontinued Application: 201150

Drug Name

SILDENAFIL CITRATE

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2012-11-09

201150 / 1

Active Ingredient

SILDENAFIL CITRATE

Application Number

201150

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2012-11-09

Regulatory Status

Discontinued

2019
25 Mar
Discontinued Application: 201171

Drug Name

SILDENAFIL CITRATE

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2019-03-25

201171 / 1

Active Ingredient

SILDENAFIL CITRATE

Application Number

201171

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2019-03-25

Regulatory Status

Discontinued

2019
25 Mar
Discontinued Application: 201171

Drug Name

SILDENAFIL CITRATE

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2019-03-25

201171 / 2

Active Ingredient

SILDENAFIL CITRATE

Application Number

201171

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2019-03-25

Regulatory Status

Discontinued

2019
25 Mar
Discontinued Application: 201171

Drug Name

SILDENAFIL CITRATE

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2019-03-25

201171 / 3

Active Ingredient

SILDENAFIL CITRATE

Application Number

201171

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2019-03-25

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 11792

Drug Name

SOMA

Product Number

3

Dosage Form

-

Strength

250MG

Approval Date

1982-01-01

11792 / 3

Active Ingredient

CARISOPRODOL

Application Number

11792

Product Number

3

Dosage Form

-

Strength

250MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1998
05 Jun
Discontinued Application: 19832

Drug Name

SULFAMYLON

Product Number

3

Dosage Form

-

Strength

5%

Approval Date

1998-06-05

19832 / 3

Active Ingredient

MAFENIDE ACETATE

Application Number

19832

Product Number

3

Dosage Form

-

Strength

5%

Approval Date

1998-06-05

Regulatory Status

Discontinued

2009
02 Nov
Discontinued Application: 77163

Drug Name

SUMATRIPTAN SUCCINATE

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2009-11-02

77163 / 1

Active Ingredient

SUMATRIPTAN SUCCINATE

Application Number

77163

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2009-11-02

Regulatory Status

Discontinued

2009
02 Nov
Discontinued Application: 77163

Drug Name

SUMATRIPTAN SUCCINATE

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2009-11-02

77163 / 2

Active Ingredient

SUMATRIPTAN SUCCINATE

Application Number

77163

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2009-11-02

Regulatory Status

Discontinued

2009
02 Nov
Discontinued Application: 77163

Drug Name

SUMATRIPTAN SUCCINATE

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2009-11-02

77163 / 3

Active Ingredient

SUMATRIPTAN SUCCINATE

Application Number

77163

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2009-11-02

Regulatory Status

Discontinued

2018
05 Feb
Discontinued Application: 208255

Drug Name

SYMFI LO

Product Number

1

Dosage Form

-

Strength

400MG;300MG;300MG

Approval Date

2018-02-05

208255 / 1

Active Ingredient

EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE

Application Number

208255

Product Number

1

Dosage Form

-

Strength

400MG;300MG;300MG

Approval Date

2018-02-05

Regulatory Status

Discontinued

2007
02 Jul
Discontinued Application: 77136

Drug Name

TERBINAFINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2007-07-02

77136 / 1

Active Ingredient

TERBINAFINE HYDROCHLORIDE

Application Number

77136

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2007-07-02

Regulatory Status

Discontinued

1983
27 Jun
Discontinued Application: 88332

Drug Name

THIORIDAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1983-06-27

88332 / 1

Active Ingredient

THIORIDAZINE HYDROCHLORIDE

Application Number

88332

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1983-06-27

Regulatory Status

Discontinued

1983
27 Jun
Discontinued Application: 88333

Drug Name

THIORIDAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1983-06-27

88333 / 1

Active Ingredient

THIORIDAZINE HYDROCHLORIDE

Application Number

88333

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1983-06-27

Regulatory Status

Discontinued

1983
27 Jun
Discontinued Application: 88334

Drug Name

THIORIDAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1983-06-27

88334 / 1

Active Ingredient

THIORIDAZINE HYDROCHLORIDE

Application Number

88334

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1983-06-27

Regulatory Status

Discontinued

1983
18 Nov
Discontinued Application: 88335

Drug Name

THIORIDAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1983-11-18

88335 / 1

Active Ingredient

THIORIDAZINE HYDROCHLORIDE

Application Number

88335

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1983-11-18

Regulatory Status

Discontinued

1999
13 Sep
Discontinued Application: 75161

Drug Name

TICLOPIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1999-09-13

75161 / 1

Active Ingredient

TICLOPIDINE HYDROCHLORIDE

Application Number

75161

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1999-09-13

Regulatory Status

Discontinued

1990
08 Jun
Discontinued Application: 72668

Drug Name

TIMOLOL MALEATE

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

1990-06-08

72668 / 1

Active Ingredient

TIMOLOL MALEATE

Application Number

72668

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

1990-06-08

Regulatory Status

Discontinued

1990
08 Jun
Discontinued Application: 72668

Drug Name

TIMOLOL MALEATE

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

1990-06-08

72668 / 2

Active Ingredient

TIMOLOL MALEATE

Application Number

72668

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

1990-06-08

Regulatory Status

Discontinued

2002
21 Nov
Discontinued Application: 75980

Drug Name

TRAMADOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2002-11-21

75980 / 1

Active Ingredient

TRAMADOL HYDROCHLORIDE

Application Number

75980

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2002-11-21

Regulatory Status

Discontinued

2002
21 Jun
Discontinued Application: 75986

Drug Name

TRAMADOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2002-06-21

75986 / 1

Active Ingredient

TRAMADOL HYDROCHLORIDE

Application Number

75986

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2002-06-21

Regulatory Status

Discontinued

2015
22 Dec
Discontinued Application: 205257

Drug Name

TRAMADOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2015-12-22

205257 / 1

Active Ingredient

TRAMADOL HYDROCHLORIDE

Application Number

205257

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2015-12-22

Regulatory Status

Discontinued

2015
22 Dec
Discontinued Application: 205257

Drug Name

TRAMADOL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2015-12-22

205257 / 2

Active Ingredient

TRAMADOL HYDROCHLORIDE

Application Number

205257

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2015-12-22

Regulatory Status

Discontinued

2015
22 Dec
Discontinued Application: 205257

Drug Name

TRAMADOL HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

2015-12-22

205257 / 3

Active Ingredient

TRAMADOL HYDROCHLORIDE

Application Number

205257

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

2015-12-22

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 84406

Drug Name

TRIAMCINOLONE

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

1982-01-01

84406 / 1

Active Ingredient

TRIAMCINOLONE

Application Number

84406

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 8814

Drug Name

UNITENSEN

Product Number

1

Dosage Form

-

Strength

260CSR UNIT/ML

Approval Date

1982-01-01

Active Ingredient

CRYPTENAMINE ACETATES

Application Number

8814

Product Number

1

Dosage Form

-

Strength

260CSR UNIT/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 9217

Drug Name

UNITENSEN

Product Number

1

Dosage Form

-

Strength

260CSR UNIT

Approval Date

1982-01-01

Active Ingredient

CRYPTENAMINE TANNATES

Application Number

9217

Product Number

1

Dosage Form

-

Strength

260CSR UNIT

Approval Date

1982-01-01

Regulatory Status

Discontinued

2011
01 Jul
Discontinued Application: 91469

Drug Name

VANCOMYCIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 10GM BASE/VIAL

Approval Date

2011-07-01

91469 / 1

Active Ingredient

VANCOMYCIN HYDROCHLORIDE

Application Number

91469

Product Number

1

Dosage Form

-

Strength

EQ 10GM BASE/VIAL

Approval Date

2011-07-01

Regulatory Status

Discontinued

2018
10 Jul
Discontinued Application: 209481

Drug Name

VANCOMYCIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2018-07-10

209481 / 1

Active Ingredient

VANCOMYCIN HYDROCHLORIDE

Application Number

209481

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2018-07-10

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 5691

Drug Name

VERTAVIS

Product Number

2

Dosage Form

-

Strength

130CSR UNIT

Approval Date

1982-01-01

Active Ingredient

VERATRUM VIRIDE ROOT

Application Number

5691

Product Number

2

Dosage Form

-

Strength

130CSR UNIT

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 11073

Drug Name

WAMPOCAP

Product Number

3

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

11073 / 3

Active Ingredient

NIACIN

Application Number

11073

Product Number

3

Dosage Form

-

Strength

500MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1996
19 Dec
Discontinued Application: 20677

Drug Name

ZAGAM

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1996-12-19

20677 / 1

Active Ingredient

SPARFLOXACIN

Application Number

20677

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1996-12-19

Regulatory Status

Discontinued

2013
10 Oct
Discontinued Application: 202395

Drug Name

ZIPRASIDONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2013-10-10

202395 / 1

Active Ingredient

ZIPRASIDONE HYDROCHLORIDE

Application Number

202395

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2013-10-10

Regulatory Status

Discontinued

2013
10 Oct
Discontinued Application: 202395

Drug Name

ZIPRASIDONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2013-10-10

202395 / 2

Active Ingredient

ZIPRASIDONE HYDROCHLORIDE

Application Number

202395

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2013-10-10

Regulatory Status

Discontinued

2013
10 Oct
Discontinued Application: 202395

Drug Name

ZIPRASIDONE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 60MG BASE

Approval Date

2013-10-10

202395 / 3

Active Ingredient

ZIPRASIDONE HYDROCHLORIDE

Application Number

202395

Product Number

3

Dosage Form

-

Strength

EQ 60MG BASE

Approval Date

2013-10-10

Regulatory Status

Discontinued

2013
10 Oct
Discontinued Application: 202395

Drug Name

ZIPRASIDONE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 80MG BASE

Approval Date

2013-10-10

202395 / 4

Active Ingredient

ZIPRASIDONE HYDROCHLORIDE

Application Number

202395

Product Number

4

Dosage Form

-

Strength

EQ 80MG BASE

Approval Date

2013-10-10

Regulatory Status

Discontinued

1991
30 Dec
Discontinued Application: 19839

Drug Name

ZOLOFT

Product Number

3

Dosage Form

-

Strength

EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1991-12-30

19839 / 3

Active Ingredient

SERTRALINE HYDROCHLORIDE

Application Number

19839

Product Number

3

Dosage Form

-

Strength

EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1991-12-30

Regulatory Status

Discontinued

1991
30 Dec
Discontinued Application: 19839

Drug Name

ZOLOFT

Product Number

4

Dosage Form

-

Strength

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

Approval Date

1991-12-30

19839 / 4

Active Ingredient

SERTRALINE HYDROCHLORIDE

Application Number

19839

Product Number

4

Dosage Form

-

Strength

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

Approval Date

1991-12-30

Regulatory Status

Discontinued

2007
23 Apr
Discontinued Application: 78016

Drug Name

ZOLPIDEM TARTRATE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2007-04-23

78016 / 1

Active Ingredient

ZOLPIDEM TARTRATE

Application Number

78016

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2007-04-23

Regulatory Status

Discontinued

2007
23 Apr
Discontinued Application: 78016

Drug Name

ZOLPIDEM TARTRATE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2007-04-23

78016 / 2

Active Ingredient

ZOLPIDEM TARTRATE

Application Number

78016

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2007-04-23

Regulatory Status

Discontinued

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Drug Status Breakdown
317 total
  • Discontinued
Official Source

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

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FDA Approved Drug Record Details Preview

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

Drug Name

ACITRETIN

Application Number

203707

Product Number

1

Active Ingredient

ACITRETIN

Dosage Form

-

Strength

17.5MG

FDA Approved Drug Data

Approved drug product information

Regular Updates

Data maintained from official sources

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