Apotex Fermentation Inc. Discontinued
FDA Approved Drugs

Apotex Fermentation Inc. 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 263
  • Latest Approval Date Jan 30, 2026
  • Data Source FDA
  • First Approval Date Jan 01, 1982
All
558
View
Unclassified
9
View
Discontinued
263
View
OTC
8
View
RX
278
View
Company Overview

Company

Apotex Fermentation Inc. Discontinued

Country

Canada

Website

Visit Website

Email

services@apoferm.com

Social Profiles

Company Snapshot

Apotex Fermentation Inc. Discontinued

50 Scurfield BoulevardWinnipeg, ManitobaCanada R3Y 1G4

Canada

www.apoferm.com/ services@apoferm.com View on Map
FDA Approved Drug Records ( 263 records )
2019
06 Sep
Discontinued Application: 210774

Drug Name

ACYCLOVIR

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

2019-09-06

210774 / 1

Active Ingredient

ACYCLOVIR

Application Number

210774

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

2019-09-06

Regulatory Status

Discontinued

2008
04 Aug
Discontinued Application: 77982

Drug Name

ALENDRONATE SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2008-08-04

77982 / 1

Active Ingredient

ALENDRONATE SODIUM

Application Number

77982

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2008-08-04

Regulatory Status

Discontinued

2008
04 Aug
Discontinued Application: 77982

Drug Name

ALENDRONATE SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2008-08-04

77982 / 2

Active Ingredient

ALENDRONATE SODIUM

Application Number

77982

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2008-08-04

Regulatory Status

Discontinued

2008
04 Aug
Discontinued Application: 77982

Drug Name

ALENDRONATE SODIUM

Product Number

3

Dosage Form

-

Strength

EQ 35MG BASE

Approval Date

2008-08-04

77982 / 3

Active Ingredient

ALENDRONATE SODIUM

Application Number

77982

Product Number

3

Dosage Form

-

Strength

EQ 35MG BASE

Approval Date

2008-08-04

Regulatory Status

Discontinued

2008
04 Aug
Discontinued Application: 77982

Drug Name

ALENDRONATE SODIUM

Product Number

4

Dosage Form

-

Strength

EQ 70MG BASE

Approval Date

2008-08-04

77982 / 4

Active Ingredient

ALENDRONATE SODIUM

Application Number

77982

Product Number

4

Dosage Form

-

Strength

EQ 70MG BASE

Approval Date

2008-08-04

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 14691

Drug Name

ALKERAN

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1982-01-01

14691 / 2

Active Ingredient

MELPHALAN

Application Number

14691

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1982-01-01

Regulatory Status

Discontinued

1992
18 Nov
Discontinued Application: 20207

Drug Name

ALKERAN

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1992-11-18

20207 / 1

Active Ingredient

MELPHALAN HYDROCHLORIDE

Application Number

20207

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1992-11-18

Regulatory Status

Discontinued

2024
16 Feb
Discontinued Application: 210091

Drug Name

APIXABAN

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2024-02-16

210091 / 1

Active Ingredient

APIXABAN

Application Number

210091

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2024-02-16

Regulatory Status

Discontinued

2024
16 Feb
Discontinued Application: 210091

Drug Name

APIXABAN

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2024-02-16

210091 / 2

Active Ingredient

APIXABAN

Application Number

210091

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2024-02-16

Regulatory Status

Discontinued

2015
24 Jul
Discontinued Application: 78583

Drug Name

ARIPIPRAZOLE

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2015-07-24

78583 / 1

Active Ingredient

ARIPIPRAZOLE

Application Number

78583

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2015-07-24

Regulatory Status

Discontinued

2015
24 Jul
Discontinued Application: 78583

Drug Name

ARIPIPRAZOLE

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2015-07-24

78583 / 2

Active Ingredient

ARIPIPRAZOLE

Application Number

78583

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2015-07-24

Regulatory Status

Discontinued

2015
24 Jul
Discontinued Application: 78583

Drug Name

ARIPIPRAZOLE

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2015-07-24

78583 / 3

Active Ingredient

ARIPIPRAZOLE

Application Number

78583

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2015-07-24

Regulatory Status

Discontinued

2015
24 Jul
Discontinued Application: 78583

Drug Name

ARIPIPRAZOLE

Product Number

4

Dosage Form

-

Strength

15MG

Approval Date

2015-07-24

78583 / 4

Active Ingredient

ARIPIPRAZOLE

Application Number

78583

Product Number

4

Dosage Form

-

Strength

15MG

Approval Date

2015-07-24

Regulatory Status

Discontinued

2015
24 Jul
Discontinued Application: 78583

Drug Name

ARIPIPRAZOLE

Product Number

5

Dosage Form

-

Strength

20MG

Approval Date

2015-07-24

78583 / 5

Active Ingredient

ARIPIPRAZOLE

Application Number

78583

Product Number

5

Dosage Form

-

Strength

20MG

Approval Date

2015-07-24

Regulatory Status

Discontinued

2015
24 Jul
Discontinued Application: 78583

Drug Name

ARIPIPRAZOLE

Product Number

6

Dosage Form

-

Strength

30MG

Approval Date

2015-07-24

78583 / 6

Active Ingredient

ARIPIPRAZOLE

Application Number

78583

Product Number

6

Dosage Form

-

Strength

30MG

Approval Date

2015-07-24

Regulatory Status

Discontinued

2017
11 Oct
Discontinued Application: 209750

Drug Name

ATOVAQUONE

Product Number

1

Dosage Form

-

Strength

750MG/5ML

Approval Date

2017-10-11

209750 / 1

Active Ingredient

ATOVAQUONE

Application Number

209750

Product Number

1

Dosage Form

-

Strength

750MG/5ML

Approval Date

2017-10-11

Regulatory Status

Discontinued

2025
30 Oct
Discontinued Application: 211650

Drug Name

AXITINIB

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2025-10-30

211650 / 1

Active Ingredient

AXITINIB

Application Number

211650

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2025-10-30

Regulatory Status

Discontinued

2025
30 Oct
Discontinued Application: 211650

Drug Name

AXITINIB

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2025-10-30

211650 / 2

Active Ingredient

AXITINIB

Application Number

211650

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2025-10-30

Regulatory Status

Discontinued

2011
13 Jul
Discontinued Application: 65507

Drug Name

AZITHROMYCIN

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2011-07-13

65507 / 1

Active Ingredient

AZITHROMYCIN

Application Number

65507

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2011-07-13

Regulatory Status

Discontinued

2011
13 Jul
Discontinued Application: 65508

Drug Name

AZITHROMYCIN

Product Number

1

Dosage Form

-

Strength

EQ 600MG BASE

Approval Date

2011-07-13

65508 / 1

Active Ingredient

AZITHROMYCIN

Application Number

65508

Product Number

1

Dosage Form

-

Strength

EQ 600MG BASE

Approval Date

2011-07-13

Regulatory Status

Discontinued

2011
13 Jul
Discontinued Application: 65509

Drug Name

AZITHROMYCIN

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2011-07-13

65509 / 1

Active Ingredient

AZITHROMYCIN

Application Number

65509

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2011-07-13

Regulatory Status

Discontinued

2014
21 Aug
Discontinued Application: 78794

Drug Name

BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

5MG;6.25MG

Approval Date

2014-08-21

78794 / 1

Active Ingredient

BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

Application Number

78794

Product Number

1

Dosage Form

-

Strength

5MG;6.25MG

Approval Date

2014-08-21

Regulatory Status

Discontinued

2014
21 Aug
Discontinued Application: 78794

Drug Name

BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

10MG;12.5MG

Approval Date

2014-08-21

78794 / 2

Active Ingredient

BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

Application Number

78794

Product Number

2

Dosage Form

-

Strength

10MG;12.5MG

Approval Date

2014-08-21

Regulatory Status

Discontinued

2014
21 Aug
Discontinued Application: 78794

Drug Name

BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

Product Number

3

Dosage Form

-

Strength

20MG;12.5MG

Approval Date

2014-08-21

78794 / 3

Active Ingredient

BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

Application Number

78794

Product Number

3

Dosage Form

-

Strength

20MG;12.5MG

Approval Date

2014-08-21

Regulatory Status

Discontinued

2014
21 Aug
Discontinued Application: 78794

Drug Name

BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

Product Number

4

Dosage Form

-

Strength

20MG;25MG

Approval Date

2014-08-21

78794 / 4

Active Ingredient

BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

Application Number

78794

Product Number

4

Dosage Form

-

Strength

20MG;25MG

Approval Date

2014-08-21

Regulatory Status

Discontinued

2023
05 Jun
Discontinued Application: 204230

Drug Name

BENDAMUSTINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG/VIAL

Approval Date

2023-06-05

204230 / 1

Active Ingredient

BENDAMUSTINE HYDROCHLORIDE

Application Number

204230

Product Number

1

Dosage Form

-

Strength

25MG/VIAL

Approval Date

2023-06-05

Regulatory Status

Discontinued

2023
05 Jun
Discontinued Application: 204230

Drug Name

BENDAMUSTINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

100MG/VIAL

Approval Date

2023-06-05

204230 / 2

Active Ingredient

BENDAMUSTINE HYDROCHLORIDE

Application Number

204230

Product Number

2

Dosage Form

-

Strength

100MG/VIAL

Approval Date

2023-06-05

Regulatory Status

Discontinued

2019
05 Mar
Discontinued Application: 206066

Drug Name

BEPOTASTINE BESILATE

Product Number

1

Dosage Form

-

Strength

1.5%

Approval Date

2019-03-05

206066 / 1

Active Ingredient

BEPOTASTINE BESILATE

Application Number

206066

Product Number

1

Dosage Form

-

Strength

1.5%

Approval Date

2019-03-05

Regulatory Status

Discontinued

2015
21 May
Discontinued Application: 200274

Drug Name

BICALUTAMIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2015-05-21

200274 / 1

Active Ingredient

BICALUTAMIDE

Application Number

200274

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2015-05-21

Regulatory Status

Discontinued

2014
01 Dec
Discontinued Application: 201894

Drug Name

BIMATOPROST

Product Number

1

Dosage Form

-

Strength

0.03%

Approval Date

2014-12-01

201894 / 1

Active Ingredient

BIMATOPROST

Application Number

201894

Product Number

1

Dosage Form

-

Strength

0.03%

Approval Date

2014-12-01

Regulatory Status

Discontinued

2017
06 Jul
Discontinued Application: 204876

Drug Name

BIVALIRUDIN

Product Number

1

Dosage Form

-

Strength

250MG/VIAL

Approval Date

2017-07-06

204876 / 1

Active Ingredient

BIVALIRUDIN

Application Number

204876

Product Number

1

Dosage Form

-

Strength

250MG/VIAL

Approval Date

2017-07-06

Regulatory Status

Discontinued

2025
24 Feb
Discontinued Application: 213731

Drug Name

BREXPIPRAZOLE

Product Number

1

Dosage Form

-

Strength

0.25MG

Approval Date

2025-02-24

213731 / 1

Active Ingredient

BREXPIPRAZOLE

Application Number

213731

Product Number

1

Dosage Form

-

Strength

0.25MG

Approval Date

2025-02-24

Regulatory Status

Discontinued

2025
24 Feb
Discontinued Application: 213731

Drug Name

BREXPIPRAZOLE

Product Number

2

Dosage Form

-

Strength

0.5MG

Approval Date

2025-02-24

213731 / 2

Active Ingredient

BREXPIPRAZOLE

Application Number

213731

Product Number

2

Dosage Form

-

Strength

0.5MG

Approval Date

2025-02-24

Regulatory Status

Discontinued

2025
24 Feb
Discontinued Application: 213731

Drug Name

BREXPIPRAZOLE

Product Number

3

Dosage Form

-

Strength

1MG

Approval Date

2025-02-24

213731 / 3

Active Ingredient

BREXPIPRAZOLE

Application Number

213731

Product Number

3

Dosage Form

-

Strength

1MG

Approval Date

2025-02-24

Regulatory Status

Discontinued

2025
24 Feb
Discontinued Application: 213731

Drug Name

BREXPIPRAZOLE

Product Number

4

Dosage Form

-

Strength

2MG

Approval Date

2025-02-24

213731 / 4

Active Ingredient

BREXPIPRAZOLE

Application Number

213731

Product Number

4

Dosage Form

-

Strength

2MG

Approval Date

2025-02-24

Regulatory Status

Discontinued

2025
24 Feb
Discontinued Application: 213731

Drug Name

BREXPIPRAZOLE

Product Number

5

Dosage Form

-

Strength

3MG

Approval Date

2025-02-24

213731 / 5

Active Ingredient

BREXPIPRAZOLE

Application Number

213731

Product Number

5

Dosage Form

-

Strength

3MG

Approval Date

2025-02-24

Regulatory Status

Discontinued

2014
19 Jun
Discontinued Application: 202435

Drug Name

BROMFENAC SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 0.09% ACID

Approval Date

2014-06-19

202435 / 1

Active Ingredient

BROMFENAC SODIUM

Application Number

202435

Product Number

1

Dosage Form

-

Strength

EQ 0.09% ACID

Approval Date

2014-06-19

Regulatory Status

Discontinued

2014
23 Jun
Discontinued Application: 202620

Drug Name

BROMFENAC SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 0.09% ACID

Approval Date

2014-06-23

202620 / 1

Active Ingredient

BROMFENAC SODIUM

Application Number

202620

Product Number

1

Dosage Form

-

Strength

EQ 0.09% ACID

Approval Date

2014-06-23

Regulatory Status

Discontinued

2019
07 May
Discontinued Application: 210448

Drug Name

BUSULFAN

Product Number

1

Dosage Form

-

Strength

6MG/ML

Approval Date

2019-05-07

210448 / 1

Active Ingredient

BUSULFAN

Application Number

210448

Product Number

1

Dosage Form

-

Strength

6MG/ML

Approval Date

2019-05-07

Regulatory Status

Discontinued

2023
10 Feb
Discontinued Application: 207736

Drug Name

CABAZITAXEL

Product Number

1

Dosage Form

-

Strength

60MG/1.5ML (40MG/ML)

Approval Date

2023-02-10

207736 / 1

Active Ingredient

CABAZITAXEL

Application Number

207736

Product Number

1

Dosage Form

-

Strength

60MG/1.5ML (40MG/ML)

Approval Date

2023-02-10

Regulatory Status

Discontinued

2013
08 Mar
Discontinued Application: 201503

Drug Name

CABERGOLINE

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2013-03-08

201503 / 1

Active Ingredient

CABERGOLINE

Application Number

201503

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2013-03-08

Regulatory Status

Discontinued

2009
11 Jun
Discontinued Application: 22348

Drug Name

CALDOLOR

Product Number

1

Dosage Form

-

Strength

400MG/4ML (100MG/ML)

Approval Date

2009-06-11

22348 / 1

Active Ingredient

IBUPROFEN

Application Number

22348

Product Number

1

Dosage Form

-

Strength

400MG/4ML (100MG/ML)

Approval Date

2009-06-11

Regulatory Status

Discontinued

2014
10 Jan
Discontinued Application: 202079

Drug Name

CANDESARTAN CILEXETIL

Product Number

1

Dosage Form

-

Strength

4MG

Approval Date

2014-01-10

202079 / 1

Active Ingredient

CANDESARTAN CILEXETIL

Application Number

202079

Product Number

1

Dosage Form

-

Strength

4MG

Approval Date

2014-01-10

Regulatory Status

Discontinued

2014
10 Jan
Discontinued Application: 202079

Drug Name

CANDESARTAN CILEXETIL

Product Number

2

Dosage Form

-

Strength

8MG

Approval Date

2014-01-10

202079 / 2

Active Ingredient

CANDESARTAN CILEXETIL

Application Number

202079

Product Number

2

Dosage Form

-

Strength

8MG

Approval Date

2014-01-10

Regulatory Status

Discontinued

2014
10 Jan
Discontinued Application: 202079

Drug Name

CANDESARTAN CILEXETIL

Product Number

3

Dosage Form

-

Strength

16MG

Approval Date

2014-01-10

202079 / 3

Active Ingredient

CANDESARTAN CILEXETIL

Application Number

202079

Product Number

3

Dosage Form

-

Strength

16MG

Approval Date

2014-01-10

Regulatory Status

Discontinued

2014
10 Jan
Discontinued Application: 202079

Drug Name

CANDESARTAN CILEXETIL

Product Number

4

Dosage Form

-

Strength

32MG

Approval Date

2014-01-10

202079 / 4

Active Ingredient

CANDESARTAN CILEXETIL

Application Number

202079

Product Number

4

Dosage Form

-

Strength

32MG

Approval Date

2014-01-10

Regulatory Status

Discontinued

2024
08 Mar
Discontinued Application: 213159

Drug Name

CARBAMAZEPINE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2024-03-08

213159 / 1

Active Ingredient

CARBAMAZEPINE

Application Number

213159

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2024-03-08

Regulatory Status

Discontinued

2024
08 Mar
Discontinued Application: 213159

Drug Name

CARBAMAZEPINE

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2024-03-08

213159 / 2

Active Ingredient

CARBAMAZEPINE

Application Number

213159

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2024-03-08

Regulatory Status

Discontinued

2024
08 Mar
Discontinued Application: 213159

Drug Name

CARBAMAZEPINE

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

2024-03-08

213159 / 3

Active Ingredient

CARBAMAZEPINE

Application Number

213159

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

2024-03-08

Regulatory Status

Discontinued

2004
16 Jun
Discontinued Application: 76212

Drug Name

CARBIDOPA AND LEVODOPA

Product Number

1

Dosage Form

-

Strength

25MG;100MG

Approval Date

2004-06-16

76212 / 1

Active Ingredient

CARBIDOPA; LEVODOPA

Application Number

76212

Product Number

1

Dosage Form

-

Strength

25MG;100MG

Approval Date

2004-06-16

Regulatory Status

Discontinued

2004
16 Jun
Discontinued Application: 76212

Drug Name

CARBIDOPA AND LEVODOPA

Product Number

2

Dosage Form

-

Strength

50MG;200MG

Approval Date

2004-06-16

76212 / 2

Active Ingredient

CARBIDOPA; LEVODOPA

Application Number

76212

Product Number

2

Dosage Form

-

Strength

50MG;200MG

Approval Date

2004-06-16

Regulatory Status

Discontinued

2020
16 Mar
Discontinued Application: 209425

Drug Name

CARFILZOMIB

Product Number

1

Dosage Form

-

Strength

60MG/VIAL

Approval Date

2020-03-16

209425 / 1

Active Ingredient

CARFILZOMIB

Application Number

209425

Product Number

1

Dosage Form

-

Strength

60MG/VIAL

Approval Date

2020-03-16

Regulatory Status

Discontinued

2020
20 Mar
Discontinued Application: 211185

Drug Name

CARFILZOMIB

Product Number

1

Dosage Form

-

Strength

30MG/VIAL

Approval Date

2020-03-20

211185 / 1

Active Ingredient

CARFILZOMIB

Application Number

211185

Product Number

1

Dosage Form

-

Strength

30MG/VIAL

Approval Date

2020-03-20

Regulatory Status

Discontinued

2002
02 Oct
Discontinued Application: 65069

Drug Name

CEFUROXIME AXETIL

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2002-10-02

65069 / 1

Active Ingredient

CEFUROXIME AXETIL

Application Number

65069

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2002-10-02

Regulatory Status

Discontinued

2002
02 Oct
Discontinued Application: 65069

Drug Name

CEFUROXIME AXETIL

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2002-10-02

65069 / 2

Active Ingredient

CEFUROXIME AXETIL

Application Number

65069

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2002-10-02

Regulatory Status

Discontinued

2016
12 Aug
Discontinued Application: 207235

Drug Name

CETIRIZINE HYDROCHLORIDE ALLERGY

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2016-08-12

207235 / 1

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

207235

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2016-08-12

Regulatory Status

Discontinued

1998
19 Jun
Discontinued Application: 74948

Drug Name

CIMETIDINE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1998-06-19

74948 / 1

Active Ingredient

CIMETIDINE

Application Number

74948

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1998-06-19

Regulatory Status

Discontinued

2002
26 Jul
Discontinued Application: 74948

Drug Name

CIMETIDINE

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2002-07-26

74948 / 2

Active Ingredient

CIMETIDINE

Application Number

74948

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2002-07-26

Regulatory Status

Discontinued

2004
24 Nov
Discontinued Application: 77046

Drug Name

CITALOPRAM HYDROBROMIDE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2004-11-24

77046 / 1

Active Ingredient

CITALOPRAM HYDROBROMIDE

Application Number

77046

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2004-11-24

Regulatory Status

Discontinued

2004
24 Nov
Discontinued Application: 77046

Drug Name

CITALOPRAM HYDROBROMIDE

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2004-11-24

77046 / 2

Active Ingredient

CITALOPRAM HYDROBROMIDE

Application Number

77046

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2004-11-24

Regulatory Status

Discontinued

2004
24 Nov
Discontinued Application: 77046

Drug Name

CITALOPRAM HYDROBROMIDE

Product Number

3

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2004-11-24

77046 / 3

Active Ingredient

CITALOPRAM HYDROBROMIDE

Application Number

77046

Product Number

3

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2004-11-24

Regulatory Status

Discontinued

2020
09 Jun
Discontinued Application: 209853

Drug Name

CLOBAZAM

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2020-06-09

209853 / 1

Active Ingredient

CLOBAZAM

Application Number

209853

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2020-06-09

Regulatory Status

Discontinued

2020
09 Jun
Discontinued Application: 209853

Drug Name

CLOBAZAM

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2020-06-09

209853 / 2

Active Ingredient

CLOBAZAM

Application Number

209853

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2020-06-09

Regulatory Status

Discontinued

2018
17 Apr
Discontinued Application: 210446

Drug Name

CLOBETASOL PROPIONATE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2018-04-17

210446 / 1

Active Ingredient

CLOBETASOL PROPIONATE

Application Number

210446

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2018-04-17

Regulatory Status

Discontinued

2024
19 Aug
Discontinued Application: 218745

Drug Name

CUPRIC SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 0.4MG COPPER/ML

Approval Date

2024-08-19

218745 / 1

Active Ingredient

CUPRIC SULFATE

Application Number

218745

Product Number

1

Dosage Form

-

Strength

EQ 0.4MG COPPER/ML

Approval Date

2024-08-19

Regulatory Status

Discontinued

2018
24 Jul
Discontinued Application: 206703

Drug Name

CYCLOBENZAPRINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2018-07-24

206703 / 1

Active Ingredient

CYCLOBENZAPRINE HYDROCHLORIDE

Application Number

206703

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2018-07-24

Regulatory Status

Discontinued

2018
24 Jul
Discontinued Application: 206703

Drug Name

CYCLOBENZAPRINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2018-07-24

206703 / 2

Active Ingredient

CYCLOBENZAPRINE HYDROCHLORIDE

Application Number

206703

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2018-07-24

Regulatory Status

Discontinued

2023
12 Jan
Discontinued Application: 207606

Drug Name

CYCLOSPORINE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2023-01-12

207606 / 1

Active Ingredient

CYCLOSPORINE

Application Number

207606

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2023-01-12

Regulatory Status

Discontinued

2014
27 May
Discontinued Application: 202027

Drug Name

DICLOFENAC SODIUM

Product Number

1

Dosage Form

-

Strength

1.5%

Approval Date

2014-05-27

202027 / 1

Active Ingredient

DICLOFENAC SODIUM

Application Number

202027

Product Number

1

Dosage Form

-

Strength

1.5%

Approval Date

2014-05-27

Regulatory Status

Discontinued

2004
20 May
Discontinued Application: 76151

Drug Name

DILT-CD

Product Number

1

Dosage Form

-

Strength

120MG

Approval Date

2004-05-20

76151 / 1

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

76151

Product Number

1

Dosage Form

-

Strength

120MG

Approval Date

2004-05-20

Regulatory Status

Discontinued

2004
20 May
Discontinued Application: 76151

Drug Name

DILT-CD

Product Number

2

Dosage Form

-

Strength

180MG

Approval Date

2004-05-20

76151 / 2

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

76151

Product Number

2

Dosage Form

-

Strength

180MG

Approval Date

2004-05-20

Regulatory Status

Discontinued

2004
20 May
Discontinued Application: 76151

Drug Name

DILT-CD

Product Number

3

Dosage Form

-

Strength

240MG

Approval Date

2004-05-20

76151 / 3

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

76151

Product Number

3

Dosage Form

-

Strength

240MG

Approval Date

2004-05-20

Regulatory Status

Discontinued

2004
20 May
Discontinued Application: 76151

Drug Name

DILT-CD

Product Number

4

Dosage Form

-

Strength

300MG

Approval Date

2004-05-20

76151 / 4

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

76151

Product Number

4

Dosage Form

-

Strength

300MG

Approval Date

2004-05-20

Regulatory Status

Discontinued

2006
01 Feb
Discontinued Application: 76395

Drug Name

DILTZAC

Product Number

1

Dosage Form

-

Strength

120MG

Approval Date

2006-02-01

76395 / 1

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

76395

Product Number

1

Dosage Form

-

Strength

120MG

Approval Date

2006-02-01

Regulatory Status

Discontinued

2006
01 Feb
Discontinued Application: 76395

Drug Name

DILTZAC

Product Number

2

Dosage Form

-

Strength

180MG

Approval Date

2006-02-01

76395 / 2

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

76395

Product Number

2

Dosage Form

-

Strength

180MG

Approval Date

2006-02-01

Regulatory Status

Discontinued

2006
01 Feb
Discontinued Application: 76395

Drug Name

DILTZAC

Product Number

3

Dosage Form

-

Strength

240MG

Approval Date

2006-02-01

76395 / 3

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

76395

Product Number

3

Dosage Form

-

Strength

240MG

Approval Date

2006-02-01

Regulatory Status

Discontinued

2006
01 Feb
Discontinued Application: 76395

Drug Name

DILTZAC

Product Number

4

Dosage Form

-

Strength

300MG

Approval Date

2006-02-01

76395 / 4

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

76395

Product Number

4

Dosage Form

-

Strength

300MG

Approval Date

2006-02-01

Regulatory Status

Discontinued

2006
01 Feb
Discontinued Application: 76395

Drug Name

DILTZAC

Product Number

5

Dosage Form

-

Strength

360MG

Approval Date

2006-02-01

76395 / 5

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

76395

Product Number

5

Dosage Form

-

Strength

360MG

Approval Date

2006-02-01

Regulatory Status

Discontinued

2008
29 Jul
Discontinued Application: 77615

Drug Name

DIVALPROEX SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 500MG VALPROIC ACID

Approval Date

2008-07-29

77615 / 1

Active Ingredient

DIVALPROEX SODIUM

Application Number

77615

Product Number

1

Dosage Form

-

Strength

EQ 500MG VALPROIC ACID

Approval Date

2008-07-29

Regulatory Status

Discontinued

2008
29 Jul
Discontinued Application: 77615

Drug Name

DIVALPROEX SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 250MG VALPROIC ACID

Approval Date

2008-07-29

77615 / 2

Active Ingredient

DIVALPROEX SODIUM

Application Number

77615

Product Number

2

Dosage Form

-

Strength

EQ 250MG VALPROIC ACID

Approval Date

2008-07-29

Regulatory Status

Discontinued

2008
29 Jul
Discontinued Application: 77615

Drug Name

DIVALPROEX SODIUM

Product Number

3

Dosage Form

-

Strength

EQ 125MG VALPROIC ACID

Approval Date

2008-07-29

77615 / 3

Active Ingredient

DIVALPROEX SODIUM

Application Number

77615

Product Number

3

Dosage Form

-

Strength

EQ 125MG VALPROIC ACID

Approval Date

2008-07-29

Regulatory Status

Discontinued

2011
02 Jun
Discontinued Application: 78841

Drug Name

DONEPEZIL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2011-06-02

78841 / 1

Active Ingredient

DONEPEZIL HYDROCHLORIDE

Application Number

78841

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2011-06-02

Regulatory Status

Discontinued

2011
02 Jun
Discontinued Application: 78841

Drug Name

DONEPEZIL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2011-06-02

78841 / 2

Active Ingredient

DONEPEZIL HYDROCHLORIDE

Application Number

78841

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2011-06-02

Regulatory Status

Discontinued

2019
15 Apr
Discontinued Application: 209243

Drug Name

DOXYCYCLINE HYCLATE

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2019-04-15

209243 / 1

Active Ingredient

DOXYCYCLINE HYCLATE

Application Number

209243

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2019-04-15

Regulatory Status

Discontinued

2019
15 Apr
Discontinued Application: 209243

Drug Name

DOXYCYCLINE HYCLATE

Product Number

2

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2019-04-15

209243 / 2

Active Ingredient

DOXYCYCLINE HYCLATE

Application Number

209243

Product Number

2

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2019-04-15

Regulatory Status

Discontinued

2016
21 Sep
Discontinued Application: 205876

Drug Name

DROSPIRENONE AND ETHINYL ESTRADIOL

Product Number

1

Dosage Form

-

Strength

3MG;0.03MG

Approval Date

2016-09-21

205876 / 1

Active Ingredient

DROSPIRENONE; ETHINYL ESTRADIOL

Application Number

205876

Product Number

1

Dosage Form

-

Strength

3MG;0.03MG

Approval Date

2016-09-21

Regulatory Status

Discontinued

2014
11 Jun
Discontinued Application: 202045

Drug Name

DULOXETINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2014-06-11

202045 / 1

Active Ingredient

DULOXETINE HYDROCHLORIDE

Application Number

202045

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2014-06-11

Regulatory Status

Discontinued

2014
11 Jun
Discontinued Application: 202045

Drug Name

DULOXETINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

2014-06-11

202045 / 2

Active Ingredient

DULOXETINE HYDROCHLORIDE

Application Number

202045

Product Number

2

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

2014-06-11

Regulatory Status

Discontinued

2014
11 Jun
Discontinued Application: 202045

Drug Name

DULOXETINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 60MG BASE

Approval Date

2014-06-11

202045 / 3

Active Ingredient

DULOXETINE HYDROCHLORIDE

Application Number

202045

Product Number

3

Dosage Form

-

Strength

EQ 60MG BASE

Approval Date

2014-06-11

Regulatory Status

Discontinued

2015
24 Nov
Discontinued Application: 204292

Drug Name

DUTASTERIDE

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2015-11-24

204292 / 1

Active Ingredient

DUTASTERIDE

Application Number

204292

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2015-11-24

Regulatory Status

Discontinued

2024
10 Jul
Discontinued Application: 212425

Drug Name

ELIGLUSTAT TARTRATE

Product Number

1

Dosage Form

-

Strength

EQ 84MG BASE

Approval Date

2024-07-10

212425 / 1

Active Ingredient

ELIGLUSTAT TARTRATE

Application Number

212425

Product Number

1

Dosage Form

-

Strength

EQ 84MG BASE

Approval Date

2024-07-10

Regulatory Status

Discontinued

2024
17 May
Discontinued Application: 214053

Drug Name

EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE

Product Number

1

Dosage Form

-

Strength

120MG;EQ 15MG BASE

Approval Date

2024-05-17

214053 / 1

Active Ingredient

EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

Application Number

214053

Product Number

1

Dosage Form

-

Strength

120MG;EQ 15MG BASE

Approval Date

2024-05-17

Regulatory Status

Discontinued

2024
17 May
Discontinued Application: 214053

Drug Name

EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE

Product Number

2

Dosage Form

-

Strength

200MG;EQ 25MG BASE

Approval Date

2024-05-17

214053 / 2

Active Ingredient

EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

Application Number

214053

Product Number

2

Dosage Form

-

Strength

200MG;EQ 25MG BASE

Approval Date

2024-05-17

Regulatory Status

Discontinued

2021
16 Jun
Discontinued Application: 208740

Drug Name

EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE

Product Number

1

Dosage Form

-

Strength

200MG;300MG

Approval Date

2021-06-16

208740 / 1

Active Ingredient

EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Application Number

208740

Product Number

1

Dosage Form

-

Strength

200MG;300MG

Approval Date

2021-06-16

Regulatory Status

Discontinued

2026
30 Jan
Discontinued Application: 214095

Drug Name

EMTRICITABINE, RILPIVIRINE, AND TENOFOVIR ALAFENAMIDE

Product Number

1

Dosage Form

-

Strength

200MG;EQ 25MG BASE;EQ 25MG BASE

Approval Date

2026-01-30

214095 / 1

Active Ingredient

EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR ALAFENAMIDE FUMARATE

Application Number

214095

Product Number

1

Dosage Form

-

Strength

200MG;EQ 25MG BASE;EQ 25MG BASE

Approval Date

2026-01-30

Regulatory Status

Discontinued

2022
22 Apr
Discontinued Application: 209645

Drug Name

ENZALUTAMIDE

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2022-04-22

209645 / 1

Active Ingredient

ENZALUTAMIDE

Application Number

209645

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2022-04-22

Regulatory Status

Discontinued

2011
31 Oct
Discontinued Application: 90919

Drug Name

EPINASTINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2011-10-31

90919 / 1

Active Ingredient

EPINASTINE HYDROCHLORIDE

Application Number

90919

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2011-10-31

Regulatory Status

Discontinued

2019
05 Nov
Discontinued Application: 208396

Drug Name

ERLOTINIB HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2019-11-05

208396 / 1

Active Ingredient

ERLOTINIB HYDROCHLORIDE

Application Number

208396

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2019-11-05

Regulatory Status

Discontinued

2019
05 Nov
Discontinued Application: 208396

Drug Name

ERLOTINIB HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2019-11-05

208396 / 2

Active Ingredient

ERLOTINIB HYDROCHLORIDE

Application Number

208396

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2019-11-05

Regulatory Status

Discontinued

2019
05 Nov
Discontinued Application: 208396

Drug Name

ERLOTINIB HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2019-11-05

208396 / 3

Active Ingredient

ERLOTINIB HYDROCHLORIDE

Application Number

208396

Product Number

3

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2019-11-05

Regulatory Status

Discontinued

2017
12 Jun
Discontinued Application: 208332

Drug Name

EZETIMIBE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2017-06-12

208332 / 1

Active Ingredient

EZETIMIBE

Application Number

208332

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2017-06-12

Regulatory Status

Discontinued

2011
22 Jul
Discontinued Application: 91480

Drug Name

FAMCICLOVIR

Product Number

1

Dosage Form

-

Strength

125MG

Approval Date

2011-07-22

91480 / 1

Active Ingredient

FAMCICLOVIR

Application Number

91480

Product Number

1

Dosage Form

-

Strength

125MG

Approval Date

2011-07-22

Regulatory Status

Discontinued

2011
22 Jul
Discontinued Application: 91480

Drug Name

FAMCICLOVIR

Product Number

2

Dosage Form

-

Strength

250MG

Approval Date

2011-07-22

91480 / 2

Active Ingredient

FAMCICLOVIR

Application Number

91480

Product Number

2

Dosage Form

-

Strength

250MG

Approval Date

2011-07-22

Regulatory Status

Discontinued

2011
22 Jul
Discontinued Application: 91480

Drug Name

FAMCICLOVIR

Product Number

3

Dosage Form

-

Strength

500MG

Approval Date

2011-07-22

91480 / 3

Active Ingredient

FAMCICLOVIR

Application Number

91480

Product Number

3

Dosage Form

-

Strength

500MG

Approval Date

2011-07-22

Regulatory Status

Discontinued

2002
12 Mar
Discontinued Application: 75610

Drug Name

FAMOTIDINE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2002-03-12

75610 / 1

Active Ingredient

FAMOTIDINE

Application Number

75610

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2002-03-12

Regulatory Status

Discontinued

2001
23 Jul
Discontinued Application: 75611

Drug Name

FAMOTIDINE

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2001-07-23

75611 / 1

Active Ingredient

FAMOTIDINE

Application Number

75611

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2001-07-23

Regulatory Status

Discontinued

2001
23 Jul
Discontinued Application: 75611

Drug Name

FAMOTIDINE

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

2001-07-23

75611 / 2

Active Ingredient

FAMOTIDINE

Application Number

75611

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

2001-07-23

Regulatory Status

Discontinued

2007
09 Aug
Discontinued Application: 77436

Drug Name

FLUNISOLIDE

Product Number

1

Dosage Form

-

Strength

0.029MG/SPRAY

Approval Date

2007-08-09

77436 / 1

Active Ingredient

FLUNISOLIDE

Application Number

77436

Product Number

1

Dosage Form

-

Strength

0.029MG/SPRAY

Approval Date

2007-08-09

Regulatory Status

Discontinued

2022
15 Jul
Discontinued Application: 216649

Drug Name

FLUPHENAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2022-07-15

216649 / 1

Active Ingredient

FLUPHENAZINE HYDROCHLORIDE

Application Number

216649

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2022-07-15

Regulatory Status

Discontinued

2022
15 Jul
Discontinued Application: 216649

Drug Name

FLUPHENAZINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

2.5MG

Approval Date

2022-07-15

216649 / 2

Active Ingredient

FLUPHENAZINE HYDROCHLORIDE

Application Number

216649

Product Number

2

Dosage Form

-

Strength

2.5MG

Approval Date

2022-07-15

Regulatory Status

Discontinued

2022
15 Jul
Discontinued Application: 216649

Drug Name

FLUPHENAZINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

2022-07-15

216649 / 3

Active Ingredient

FLUPHENAZINE HYDROCHLORIDE

Application Number

216649

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

2022-07-15

Regulatory Status

Discontinued

2022
15 Jul
Discontinued Application: 216649

Drug Name

FLUPHENAZINE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2022-07-15

216649 / 4

Active Ingredient

FLUPHENAZINE HYDROCHLORIDE

Application Number

216649

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2022-07-15

Regulatory Status

Discontinued

2019
05 Sep
Discontinued Application: 205020

Drug Name

FOSAPREPITANT DIMEGLUMINE

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE/VIAL

Approval Date

2019-09-05

205020 / 1

Active Ingredient

FOSAPREPITANT DIMEGLUMINE

Application Number

205020

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE/VIAL

Approval Date

2019-09-05

Regulatory Status

Discontinued

2005
17 May
Discontinued Application: 76906

Drug Name

FOSINOPRIL SODIUM

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2005-05-17

76906 / 1

Active Ingredient

FOSINOPRIL SODIUM

Application Number

76906

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2005-05-17

Regulatory Status

Discontinued

2005
17 May
Discontinued Application: 76906

Drug Name

FOSINOPRIL SODIUM

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2005-05-17

76906 / 2

Active Ingredient

FOSINOPRIL SODIUM

Application Number

76906

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2005-05-17

Regulatory Status

Discontinued

2005
17 May
Discontinued Application: 76906

Drug Name

FOSINOPRIL SODIUM

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2005-05-17

76906 / 3

Active Ingredient

FOSINOPRIL SODIUM

Application Number

76906

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2005-05-17

Regulatory Status

Discontinued

2021
11 Jun
Discontinued Application: 211730

Drug Name

FULVESTRANT

Product Number

1

Dosage Form

-

Strength

250MG/5ML (50MG/ML)

Approval Date

2021-06-11

211730 / 1

Active Ingredient

FULVESTRANT

Application Number

211730

Product Number

1

Dosage Form

-

Strength

250MG/5ML (50MG/ML)

Approval Date

2021-06-11

Regulatory Status

Discontinued

2006
10 Oct
Discontinued Application: 77894

Drug Name

GABAPENTIN

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2006-10-10

77894 / 1

Active Ingredient

GABAPENTIN

Application Number

77894

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2006-10-10

Regulatory Status

Discontinued

2006
10 Oct
Discontinued Application: 77894

Drug Name

GABAPENTIN

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2006-10-10

77894 / 2

Active Ingredient

GABAPENTIN

Application Number

77894

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2006-10-10

Regulatory Status

Discontinued

2006
10 Oct
Discontinued Application: 77894

Drug Name

GABAPENTIN

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

2006-10-10

77894 / 3

Active Ingredient

GABAPENTIN

Application Number

77894

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

2006-10-10

Regulatory Status

Discontinued

2022
23 Sep
Discontinued Application: 209532

Drug Name

GEFITINIB

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2022-09-23

209532 / 1

Active Ingredient

GEFITINIB

Application Number

209532

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2022-09-23

Regulatory Status

Discontinued

2017
23 May
Discontinued Application: 206776

Drug Name

GEMCITABINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

200MG/5.26ML (38MG/ML)

Approval Date

2017-05-23

206776 / 1

Active Ingredient

GEMCITABINE HYDROCHLORIDE

Application Number

206776

Product Number

1

Dosage Form

-

Strength

200MG/5.26ML (38MG/ML)

Approval Date

2017-05-23

Regulatory Status

Discontinued

2017
23 May
Discontinued Application: 206776

Drug Name

GEMCITABINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

1GM/26.3ML (38MG/ML)

Approval Date

2017-05-23

206776 / 2

Active Ingredient

GEMCITABINE HYDROCHLORIDE

Application Number

206776

Product Number

2

Dosage Form

-

Strength

1GM/26.3ML (38MG/ML)

Approval Date

2017-05-23

Regulatory Status

Discontinued

2017
23 May
Discontinued Application: 206776

Drug Name

GEMCITABINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

2GM/52.6ML (38MG/ML)

Approval Date

2017-05-23

206776 / 3

Active Ingredient

GEMCITABINE HYDROCHLORIDE

Application Number

206776

Product Number

3

Dosage Form

-

Strength

2GM/52.6ML (38MG/ML)

Approval Date

2017-05-23

Regulatory Status

Discontinued

1998
20 Jul
Discontinued Application: 75034

Drug Name

GEMFIBROZIL

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

1998-07-20

75034 / 1

Active Ingredient

GEMFIBROZIL

Application Number

75034

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

1998-07-20

Regulatory Status

Discontinued

2019
29 Oct
Discontinued Application: 210246

Drug Name

GLYCOPYRROLATE

Product Number

1

Dosage Form

-

Strength

0.2MG/ML

Approval Date

2019-10-29

210246 / 1

Active Ingredient

GLYCOPYRROLATE

Application Number

210246

Product Number

1

Dosage Form

-

Strength

0.2MG/ML

Approval Date

2019-10-29

Regulatory Status

Discontinued

2007
03 Oct
Discontinued Application: 40774

Drug Name

HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2007-10-03

40774 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE

Application Number

40774

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2007-10-03

Regulatory Status

Discontinued

2007
03 Oct
Discontinued Application: 40774

Drug Name

HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2007-10-03

40774 / 2

Active Ingredient

HYDROCHLOROTHIAZIDE

Application Number

40774

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2007-10-03

Regulatory Status

Discontinued

2008
16 May
Discontinued Application: 78389

Drug Name

HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

2008-05-16

78389 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE

Application Number

78389

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

2008-05-16

Regulatory Status

Discontinued

2019
02 Aug
Discontinued Application: 208481

Drug Name

ITRACONAZOLE

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2019-08-02

208481 / 1

Active Ingredient

ITRACONAZOLE

Application Number

208481

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2019-08-02

Regulatory Status

Discontinued

2009
05 Nov
Discontinued Application: 77308

Drug Name

KETOROLAC TROMETHAMINE

Product Number

1

Dosage Form

-

Strength

0.4%

Approval Date

2009-11-05

77308 / 1

Active Ingredient

KETOROLAC TROMETHAMINE

Application Number

77308

Product Number

1

Dosage Form

-

Strength

0.4%

Approval Date

2009-11-05

Regulatory Status

Discontinued

2022
26 Sep
Discontinued Application: 206355

Drug Name

LACOSAMIDE

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2022-09-26

206355 / 1

Active Ingredient

LACOSAMIDE

Application Number

206355

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2022-09-26

Regulatory Status

Discontinued

2022
23 Sep
Discontinued Application: 214567

Drug Name

LACOSAMIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2022-09-23

214567 / 1

Active Ingredient

LACOSAMIDE

Application Number

214567

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2022-09-23

Regulatory Status

Discontinued

2022
23 Sep
Discontinued Application: 214567

Drug Name

LACOSAMIDE

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2022-09-23

214567 / 2

Active Ingredient

LACOSAMIDE

Application Number

214567

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2022-09-23

Regulatory Status

Discontinued

2022
23 Sep
Discontinued Application: 214567

Drug Name

LACOSAMIDE

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2022-09-23

214567 / 3

Active Ingredient

LACOSAMIDE

Application Number

214567

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2022-09-23

Regulatory Status

Discontinued

2022
23 Sep
Discontinued Application: 214567

Drug Name

LACOSAMIDE

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2022-09-23

214567 / 4

Active Ingredient

LACOSAMIDE

Application Number

214567

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2022-09-23

Regulatory Status

Discontinued

2015
25 Feb
Discontinued Application: 202958

Drug Name

LEVETIRACETAM

Product Number

1

Dosage Form

-

Strength

1GM

Approval Date

2015-02-25

202958 / 1

Active Ingredient

LEVETIRACETAM

Application Number

202958

Product Number

1

Dosage Form

-

Strength

1GM

Approval Date

2015-02-25

Regulatory Status

Discontinued

2014
21 Aug
Discontinued Application: 202915

Drug Name

LEVOCETIRIZINE DIHYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

2.5MG/5ML

Approval Date

2014-08-21

202915 / 1

Active Ingredient

LEVOCETIRIZINE DIHYDROCHLORIDE

Application Number

202915

Product Number

1

Dosage Form

-

Strength

2.5MG/5ML

Approval Date

2014-08-21

Regulatory Status

Discontinued

2015
13 Feb
Discontinued Application: 203027

Drug Name

LEVOCETIRIZINE DIHYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2015-02-13

203027 / 1

Active Ingredient

LEVOCETIRIZINE DIHYDROCHLORIDE

Application Number

203027

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2015-02-13

Regulatory Status

Discontinued

2021
21 Apr
Discontinued Application: 211443

Drug Name

LEVOCETIRIZINE DIHYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2021-04-21

211443 / 1

Active Ingredient

LEVOCETIRIZINE DIHYDROCHLORIDE

Application Number

211443

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2021-04-21

Regulatory Status

Discontinued

2010
06 Oct
Discontinued Application: 90790

Drug Name

LOSARTAN POTASSIUM

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2010-10-06

90790 / 1

Active Ingredient

LOSARTAN POTASSIUM

Application Number

90790

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2010-10-06

Regulatory Status

Discontinued

2010
06 Oct
Discontinued Application: 90790

Drug Name

LOSARTAN POTASSIUM

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2010-10-06

90790 / 2

Active Ingredient

LOSARTAN POTASSIUM

Application Number

90790

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2010-10-06

Regulatory Status

Discontinued

2010
06 Oct
Discontinued Application: 90790

Drug Name

LOSARTAN POTASSIUM

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2010-10-06

90790 / 3

Active Ingredient

LOSARTAN POTASSIUM

Application Number

90790

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2010-10-06

Regulatory Status

Discontinued

2024
04 Jun
Discontinued Application: 218551

Drug Name

LOSARTAN POTASSIUM

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2024-06-04

218551 / 1

Active Ingredient

LOSARTAN POTASSIUM

Application Number

218551

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2024-06-04

Regulatory Status

Discontinued

2024
04 Jun
Discontinued Application: 218551

Drug Name

LOSARTAN POTASSIUM

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2024-06-04

218551 / 2

Active Ingredient

LOSARTAN POTASSIUM

Application Number

218551

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2024-06-04

Regulatory Status

Discontinued

2024
04 Jun
Discontinued Application: 218551

Drug Name

LOSARTAN POTASSIUM

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2024-06-04

218551 / 3

Active Ingredient

LOSARTAN POTASSIUM

Application Number

218551

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2024-06-04

Regulatory Status

Discontinued

2010
06 Oct
Discontinued Application: 90150

Drug Name

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

12.5MG;50MG

Approval Date

2010-10-06

90150 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM

Application Number

90150

Product Number

1

Dosage Form

-

Strength

12.5MG;50MG

Approval Date

2010-10-06

Regulatory Status

Discontinued

2010
11 Aug
Discontinued Application: 90150

Drug Name

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

12.5MG;100MG

Approval Date

2010-08-11

90150 / 2

Active Ingredient

HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM

Application Number

90150

Product Number

2

Dosage Form

-

Strength

12.5MG;100MG

Approval Date

2010-08-11

Regulatory Status

Discontinued

2010
06 Oct
Discontinued Application: 90150

Drug Name

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

Product Number

3

Dosage Form

-

Strength

25MG;100MG

Approval Date

2010-10-06

90150 / 3

Active Ingredient

HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM

Application Number

90150

Product Number

3

Dosage Form

-

Strength

25MG;100MG

Approval Date

2010-10-06

Regulatory Status

Discontinued

2016
22 Nov
Discontinued Application: 206135

Drug Name

MEMANTINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

7MG

Approval Date

2016-11-22

206135 / 1

Active Ingredient

MEMANTINE HYDROCHLORIDE

Application Number

206135

Product Number

1

Dosage Form

-

Strength

7MG

Approval Date

2016-11-22

Regulatory Status

Discontinued

2016
22 Nov
Discontinued Application: 206135

Drug Name

MEMANTINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

14MG

Approval Date

2016-11-22

206135 / 2

Active Ingredient

MEMANTINE HYDROCHLORIDE

Application Number

206135

Product Number

2

Dosage Form

-

Strength

14MG

Approval Date

2016-11-22

Regulatory Status

Discontinued

2016
22 Nov
Discontinued Application: 206135

Drug Name

MEMANTINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

21MG

Approval Date

2016-11-22

206135 / 3

Active Ingredient

MEMANTINE HYDROCHLORIDE

Application Number

206135

Product Number

3

Dosage Form

-

Strength

21MG

Approval Date

2016-11-22

Regulatory Status

Discontinued

2016
22 Nov
Discontinued Application: 206135

Drug Name

MEMANTINE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

28MG

Approval Date

2016-11-22

206135 / 4

Active Ingredient

MEMANTINE HYDROCHLORIDE

Application Number

206135

Product Number

4

Dosage Form

-

Strength

28MG

Approval Date

2016-11-22

Regulatory Status

Discontinued

2002
23 Apr
Discontinued Application: 75984

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2002-04-23

75984 / 1

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

75984

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2002-04-23

Regulatory Status

Discontinued

2002
23 Apr
Discontinued Application: 75984

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

850MG

Approval Date

2002-04-23

75984 / 2

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

75984

Product Number

2

Dosage Form

-

Strength

850MG

Approval Date

2002-04-23

Regulatory Status

Discontinued

2002
23 Apr
Discontinued Application: 75984

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

1GM

Approval Date

2002-04-23

75984 / 3

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

75984

Product Number

3

Dosage Form

-

Strength

1GM

Approval Date

2002-04-23

Regulatory Status

Discontinued

2004
14 Dec
Discontinued Application: 76706

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2004-12-14

76706 / 1

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

76706

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2004-12-14

Regulatory Status

Discontinued

2005
29 Dec
Discontinued Application: 76706

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

750MG

Approval Date

2005-12-29

76706 / 2

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

76706

Product Number

2

Dosage Form

-

Strength

750MG

Approval Date

2005-12-29

Regulatory Status

Discontinued

2011
07 Dec
Discontinued Application: 90666

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2011-12-07

90666 / 1

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

90666

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2011-12-07

Regulatory Status

Discontinued

2011
07 Dec
Discontinued Application: 90666

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

850MG

Approval Date

2011-12-07

90666 / 2

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

90666

Product Number

2

Dosage Form

-

Strength

850MG

Approval Date

2011-12-07

Regulatory Status

Discontinued

2011
07 Dec
Discontinued Application: 90666

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

1GM

Approval Date

2011-12-07

90666 / 3

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

90666

Product Number

3

Dosage Form

-

Strength

1GM

Approval Date

2011-12-07

Regulatory Status

Discontinued

2021
13 Dec
Discontinued Application: 213356

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2021-12-13

213356 / 1

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

213356

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2021-12-13

Regulatory Status

Discontinued

2021
13 Dec
Discontinued Application: 213356

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

1GM

Approval Date

2021-12-13

213356 / 2

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

213356

Product Number

2

Dosage Form

-

Strength

1GM

Approval Date

2021-12-13

Regulatory Status

Discontinued

2020
05 Nov
Discontinued Application: 208366

Drug Name

MICAFUNGIN SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/VIAL

Approval Date

2020-11-05

208366 / 1

Active Ingredient

MICAFUNGIN SODIUM

Application Number

208366

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/VIAL

Approval Date

2020-11-05

Regulatory Status

Discontinued

2020
05 Nov
Discontinued Application: 208366

Drug Name

MICAFUNGIN SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE/VIAL

Approval Date

2020-11-05

208366 / 2

Active Ingredient

MICAFUNGIN SODIUM

Application Number

208366

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE/VIAL

Approval Date

2020-11-05

Regulatory Status

Discontinued

2025
02 Jan
Discontinued Application: 209434

Drug Name

MIRABEGRON

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2025-01-02

209434 / 1

Active Ingredient

MIRABEGRON

Application Number

209434

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2025-01-02

Regulatory Status

Discontinued

2025
02 Jan
Discontinued Application: 209434

Drug Name

MIRABEGRON

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2025-01-02

209434 / 2

Active Ingredient

MIRABEGRON

Application Number

209434

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2025-01-02

Regulatory Status

Discontinued

2024
23 Apr
Discontinued Application: 217438

Drug Name

MOMETASONE FUROATE

Product Number

1

Dosage Form

-

Strength

0.05MG/SPRAY

Approval Date

2024-04-23

217438 / 1

Active Ingredient

MOMETASONE FUROATE

Application Number

217438

Product Number

1

Dosage Form

-

Strength

0.05MG/SPRAY

Approval Date

2024-04-23

Regulatory Status

Discontinued

2012
03 Aug
Discontinued Application: 201294

Drug Name

MONTELUKAST SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2012-08-03

201294 / 1

Active Ingredient

MONTELUKAST SODIUM

Application Number

201294

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2012-08-03

Regulatory Status

Discontinued

2009
22 Apr
Discontinued Application: 90419

Drug Name

MYCOPHENOLATE MOFETIL

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2009-04-22

90419 / 1

Active Ingredient

MYCOPHENOLATE MOFETIL

Application Number

90419

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2009-04-22

Regulatory Status

Discontinued

2009
22 Apr
Discontinued Application: 90499

Drug Name

MYCOPHENOLATE MOFETIL

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2009-04-22

90499 / 1

Active Ingredient

MYCOPHENOLATE MOFETIL

Application Number

90499

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2009-04-22

Regulatory Status

Discontinued

2011
22 Apr
Discontinued Application: 91373

Drug Name

NARATRIPTAN

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2011-04-22

91373 / 1

Active Ingredient

NARATRIPTAN HYDROCHLORIDE

Application Number

91373

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2011-04-22

Regulatory Status

Discontinued

2011
22 Apr
Discontinued Application: 91373

Drug Name

NARATRIPTAN

Product Number

2

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2011-04-22

91373 / 2

Active Ingredient

NARATRIPTAN HYDROCHLORIDE

Application Number

91373

Product Number

2

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2011-04-22

Regulatory Status

Discontinued

2024
27 Feb
Discontinued Application: 209741

Drug Name

NEBIVOLOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2024-02-27

209741 / 1

Active Ingredient

NEBIVOLOL HYDROCHLORIDE

Application Number

209741

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2024-02-27

Regulatory Status

Discontinued

2024
27 Feb
Discontinued Application: 209741

Drug Name

NEBIVOLOL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2024-02-27

209741 / 2

Active Ingredient

NEBIVOLOL HYDROCHLORIDE

Application Number

209741

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2024-02-27

Regulatory Status

Discontinued

2014
03 Apr
Discontinued Application: 205258

Drug Name

NEVIRAPINE

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

2014-04-03

205258 / 1

Active Ingredient

NEVIRAPINE

Application Number

205258

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

2014-04-03

Regulatory Status

Discontinued

2018
21 Mar
Discontinued Application: 208639

Drug Name

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

Product Number

1

Dosage Form

-

Strength

0.02MG;1MG

Approval Date

2018-03-21

208639 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Application Number

208639

Product Number

1

Dosage Form

-

Strength

0.02MG;1MG

Approval Date

2018-03-21

Regulatory Status

Discontinued

2023
30 May
Discontinued Application: 214862

Drug Name

OBETICHOLIC ACID

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2023-05-30

214862 / 1

Active Ingredient

OBETICHOLIC ACID

Application Number

214862

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2023-05-30

Regulatory Status

Discontinued

2023
30 May
Discontinued Application: 214862

Drug Name

OBETICHOLIC ACID

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2023-05-30

214862 / 2

Active Ingredient

OBETICHOLIC ACID

Application Number

214862

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2023-05-30

Regulatory Status

Discontinued

2014
30 Sep
Discontinued Application: 90973

Drug Name

OMEGA-3-ACID ETHYL ESTERS

Product Number

1

Dosage Form

-

Strength

1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS

Approval Date

2014-09-30

90973 / 1

Active Ingredient

OMEGA-3-ACID ETHYL ESTERS

Application Number

90973

Product Number

1

Dosage Form

-

Strength

1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS

Approval Date

2014-09-30

Regulatory Status

Discontinued

2019
11 Feb
Discontinued Application: 210070

Drug Name

OMEPRAZOLE

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2019-02-11

210070 / 1

Active Ingredient

OMEPRAZOLE

Application Number

210070

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2019-02-11

Regulatory Status

Discontinued

2007
25 Jun
Discontinued Application: 77306

Drug Name

ONDANSETRON HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2007-06-25

77306 / 1

Active Ingredient

ONDANSETRON HYDROCHLORIDE

Application Number

77306

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2007-06-25

Regulatory Status

Discontinued

2007
25 Jun
Discontinued Application: 77306

Drug Name

ONDANSETRON HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 8MG BASE

Approval Date

2007-06-25

77306 / 2

Active Ingredient

ONDANSETRON HYDROCHLORIDE

Application Number

77306

Product Number

2

Dosage Form

-

Strength

EQ 8MG BASE

Approval Date

2007-06-25

Regulatory Status

Discontinued

2026
26 Jan
Discontinued Application: 203279

Drug Name

PALIPERIDONE

Product Number

1

Dosage Form

-

Strength

3MG

Approval Date

2026-01-26

203279 / 1

Active Ingredient

PALIPERIDONE

Application Number

203279

Product Number

1

Dosage Form

-

Strength

3MG

Approval Date

2026-01-26

Regulatory Status

Discontinued

2026
26 Jan
Discontinued Application: 203279

Drug Name

PALIPERIDONE

Product Number

2

Dosage Form

-

Strength

6MG

Approval Date

2026-01-26

203279 / 2

Active Ingredient

PALIPERIDONE

Application Number

203279

Product Number

2

Dosage Form

-

Strength

6MG

Approval Date

2026-01-26

Regulatory Status

Discontinued

2026
26 Jan
Discontinued Application: 203279

Drug Name

PALIPERIDONE

Product Number

3

Dosage Form

-

Strength

9MG

Approval Date

2026-01-26

203279 / 3

Active Ingredient

PALIPERIDONE

Application Number

203279

Product Number

3

Dosage Form

-

Strength

9MG

Approval Date

2026-01-26

Regulatory Status

Discontinued

1992
29 Dec
Discontinued Application: 20031

Drug Name

PAXIL

Product Number

4

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

1992-12-29

20031 / 4

Active Ingredient

PAROXETINE HYDROCHLORIDE

Application Number

20031

Product Number

4

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

1992-12-29

Regulatory Status

Discontinued

1997
25 Jun
Discontinued Application: 20710

Drug Name

PAXIL

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1997-06-25

20710 / 1

Active Ingredient

PAROXETINE HYDROCHLORIDE

Application Number

20710

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1997-06-25

Regulatory Status

Discontinued

1998
09 Oct
Discontinued Application: 20885

Drug Name

PAXIL

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1998-10-09

20885 / 1

Active Ingredient

PAROXETINE HYDROCHLORIDE

Application Number

20885

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1998-10-09

Regulatory Status

Discontinued

1998
09 Oct
Discontinued Application: 20885

Drug Name

PAXIL

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1998-10-09

20885 / 2

Active Ingredient

PAROXETINE HYDROCHLORIDE

Application Number

20885

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1998-10-09

Regulatory Status

Discontinued

1998
09 Oct
Discontinued Application: 20885

Drug Name

PAXIL

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1998-10-09

20885 / 3

Active Ingredient

PAROXETINE HYDROCHLORIDE

Application Number

20885

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1998-10-09

Regulatory Status

Discontinued

1998
09 Oct
Discontinued Application: 20885

Drug Name

PAXIL

Product Number

4

Dosage Form

-

Strength

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

Approval Date

1998-10-09

20885 / 4

Active Ingredient

PAROXETINE HYDROCHLORIDE

Application Number

20885

Product Number

4

Dosage Form

-

Strength

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

Approval Date

1998-10-09

Regulatory Status

Discontinued

2022
25 May
Discontinued Application: 209085

Drug Name

PEMETREXED DISODIUM

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2022-05-25

209085 / 1

Active Ingredient

PEMETREXED DISODIUM

Application Number

209085

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2022-05-25

Regulatory Status

Discontinued

2020
28 Apr
Discontinued Application: 213310

Drug Name

PENICILLAMINE

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2020-04-28

213310 / 1

Active Ingredient

PENICILLAMINE

Application Number

213310

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2020-04-28

Regulatory Status

Discontinued

2010
30 Aug
Discontinued Application: 90463

Drug Name

PERINDOPRIL ERBUMINE

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2010-08-30

90463 / 1

Active Ingredient

PERINDOPRIL ERBUMINE

Application Number

90463

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2010-08-30

Regulatory Status

Discontinued

2010
30 Aug
Discontinued Application: 90463

Drug Name

PERINDOPRIL ERBUMINE

Product Number

2

Dosage Form

-

Strength

4MG

Approval Date

2010-08-30

90463 / 2

Active Ingredient

PERINDOPRIL ERBUMINE

Application Number

90463

Product Number

2

Dosage Form

-

Strength

4MG

Approval Date

2010-08-30

Regulatory Status

Discontinued

2010
30 Aug
Discontinued Application: 90463

Drug Name

PERINDOPRIL ERBUMINE

Product Number

3

Dosage Form

-

Strength

8MG

Approval Date

2010-08-30

90463 / 3

Active Ingredient

PERINDOPRIL ERBUMINE

Application Number

90463

Product Number

3

Dosage Form

-

Strength

8MG

Approval Date

2010-08-30

Regulatory Status

Discontinued

2023
09 Jun
Discontinued Application: 212687

Drug Name

PIRFENIDONE

Product Number

1

Dosage Form

-

Strength

267MG

Approval Date

2023-06-09

212687 / 1

Active Ingredient

PIRFENIDONE

Application Number

212687

Product Number

1

Dosage Form

-

Strength

267MG

Approval Date

2023-06-09

Regulatory Status

Discontinued

2023
14 Jul
Discontinued Application: 215893

Drug Name

PONATINIB HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 15MG BASE

Approval Date

2023-07-14

215893 / 1

Active Ingredient

PONATINIB HYDROCHLORIDE

Application Number

215893

Product Number

1

Dosage Form

-

Strength

EQ 15MG BASE

Approval Date

2023-07-14

Regulatory Status

Discontinued

2023
14 Jul
Discontinued Application: 215893

Drug Name

PONATINIB HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 45MG BASE

Approval Date

2023-07-14

215893 / 2

Active Ingredient

PONATINIB HYDROCHLORIDE

Application Number

215893

Product Number

2

Dosage Form

-

Strength

EQ 45MG BASE

Approval Date

2023-07-14

Regulatory Status

Discontinued

2018
08 Aug
Discontinued Application: 211067

Drug Name

POTASSIUM CHLORIDE

Product Number

1

Dosage Form

-

Strength

20MEQ/15ML

Approval Date

2018-08-08

211067 / 1

Active Ingredient

POTASSIUM CHLORIDE

Application Number

211067

Product Number

1

Dosage Form

-

Strength

20MEQ/15ML

Approval Date

2018-08-08

Regulatory Status

Discontinued

2018
08 Aug
Discontinued Application: 211067

Drug Name

POTASSIUM CHLORIDE

Product Number

2

Dosage Form

-

Strength

40MEQ/15ML

Approval Date

2018-08-08

211067 / 2

Active Ingredient

POTASSIUM CHLORIDE

Application Number

211067

Product Number

2

Dosage Form

-

Strength

40MEQ/15ML

Approval Date

2018-08-08

Regulatory Status

Discontinued

2021
07 Jul
Discontinued Application: 211685

Drug Name

PREGABALIN

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2021-07-07

211685 / 1

Active Ingredient

PREGABALIN

Application Number

211685

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2021-07-07

Regulatory Status

Discontinued

2021
07 Jul
Discontinued Application: 211685

Drug Name

PREGABALIN

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2021-07-07

211685 / 2

Active Ingredient

PREGABALIN

Application Number

211685

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2021-07-07

Regulatory Status

Discontinued

2021
07 Jul
Discontinued Application: 211685

Drug Name

PREGABALIN

Product Number

3

Dosage Form

-

Strength

75MG

Approval Date

2021-07-07

211685 / 3

Active Ingredient

PREGABALIN

Application Number

211685

Product Number

3

Dosage Form

-

Strength

75MG

Approval Date

2021-07-07

Regulatory Status

Discontinued

2021
07 Jul
Discontinued Application: 211685

Drug Name

PREGABALIN

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

2021-07-07

211685 / 4

Active Ingredient

PREGABALIN

Application Number

211685

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

2021-07-07

Regulatory Status

Discontinued

2021
07 Jul
Discontinued Application: 211685

Drug Name

PREGABALIN

Product Number

5

Dosage Form

-

Strength

150MG

Approval Date

2021-07-07

211685 / 5

Active Ingredient

PREGABALIN

Application Number

211685

Product Number

5

Dosage Form

-

Strength

150MG

Approval Date

2021-07-07

Regulatory Status

Discontinued

2021
07 Jul
Discontinued Application: 211685

Drug Name

PREGABALIN

Product Number

6

Dosage Form

-

Strength

200MG

Approval Date

2021-07-07

211685 / 6

Active Ingredient

PREGABALIN

Application Number

211685

Product Number

6

Dosage Form

-

Strength

200MG

Approval Date

2021-07-07

Regulatory Status

Discontinued

2021
07 Jul
Discontinued Application: 211685

Drug Name

PREGABALIN

Product Number

7

Dosage Form

-

Strength

225MG

Approval Date

2021-07-07

211685 / 7

Active Ingredient

PREGABALIN

Application Number

211685

Product Number

7

Dosage Form

-

Strength

225MG

Approval Date

2021-07-07

Regulatory Status

Discontinued

2021
07 Jul
Discontinued Application: 211685

Drug Name

PREGABALIN

Product Number

8

Dosage Form

-

Strength

300MG

Approval Date

2021-07-07

211685 / 8

Active Ingredient

PREGABALIN

Application Number

211685

Product Number

8

Dosage Form

-

Strength

300MG

Approval Date

2021-07-07

Regulatory Status

Discontinued

2021
13 Apr
Discontinued Application: 213313

Drug Name

PREGABALIN

Product Number

1

Dosage Form

-

Strength

165MG

Approval Date

2021-04-13

213313 / 1

Active Ingredient

PREGABALIN

Application Number

213313

Product Number

1

Dosage Form

-

Strength

165MG

Approval Date

2021-04-13

Regulatory Status

Discontinued

2021
13 Apr
Discontinued Application: 213313

Drug Name

PREGABALIN

Product Number

2

Dosage Form

-

Strength

330MG

Approval Date

2021-04-13

213313 / 2

Active Ingredient

PREGABALIN

Application Number

213313

Product Number

2

Dosage Form

-

Strength

330MG

Approval Date

2021-04-13

Regulatory Status

Discontinued

2013
12 Mar
Discontinued Application: 91524

Drug Name

QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

12.5MG;EQ 10MG BASE

Approval Date

2013-03-12

91524 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE

Application Number

91524

Product Number

1

Dosage Form

-

Strength

12.5MG;EQ 10MG BASE

Approval Date

2013-03-12

Regulatory Status

Discontinued

2013
12 Mar
Discontinued Application: 91524

Drug Name

QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

12.5MG;EQ 20MG BASE

Approval Date

2013-03-12

91524 / 2

Active Ingredient

HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE

Application Number

91524

Product Number

2

Dosage Form

-

Strength

12.5MG;EQ 20MG BASE

Approval Date

2013-03-12

Regulatory Status

Discontinued

2013
12 Mar
Discontinued Application: 91524

Drug Name

QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

Product Number

3

Dosage Form

-

Strength

25MG;EQ 20MG BASE

Approval Date

2013-03-12

91524 / 3

Active Ingredient

HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE

Application Number

91524

Product Number

3

Dosage Form

-

Strength

25MG;EQ 20MG BASE

Approval Date

2013-03-12

Regulatory Status

Discontinued

2015
02 Dec
Discontinued Application: 91069

Drug Name

RAMIPRIL

Product Number

1

Dosage Form

-

Strength

1.25MG

Approval Date

2015-12-02

91069 / 1

Active Ingredient

RAMIPRIL

Application Number

91069

Product Number

1

Dosage Form

-

Strength

1.25MG

Approval Date

2015-12-02

Regulatory Status

Discontinued

2015
02 Dec
Discontinued Application: 91069

Drug Name

RAMIPRIL

Product Number

2

Dosage Form

-

Strength

2.5MG

Approval Date

2015-12-02

91069 / 2

Active Ingredient

RAMIPRIL

Application Number

91069

Product Number

2

Dosage Form

-

Strength

2.5MG

Approval Date

2015-12-02

Regulatory Status

Discontinued

2015
02 Dec
Discontinued Application: 91069

Drug Name

RAMIPRIL

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

2015-12-02

91069 / 3

Active Ingredient

RAMIPRIL

Application Number

91069

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

2015-12-02

Regulatory Status

Discontinued

2015
02 Dec
Discontinued Application: 91069

Drug Name

RAMIPRIL

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2015-12-02

91069 / 4

Active Ingredient

RAMIPRIL

Application Number

91069

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2015-12-02

Regulatory Status

Discontinued

1997
12 Sep
Discontinued Application: 74680

Drug Name

RANITIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

1997-09-12

74680 / 1

Active Ingredient

RANITIDINE HYDROCHLORIDE

Application Number

74680

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

1997-09-12

Regulatory Status

Discontinued

1997
12 Sep
Discontinued Application: 74680

Drug Name

RANITIDINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

1997-09-12

74680 / 2

Active Ingredient

RANITIDINE HYDROCHLORIDE

Application Number

74680

Product Number

2

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

1997-09-12

Regulatory Status

Discontinued

2000
04 May
Discontinued Application: 75167

Drug Name

RANITIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2000-05-04

75167 / 1

Active Ingredient

RANITIDINE HYDROCHLORIDE

Application Number

75167

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2000-05-04

Regulatory Status

Discontinued

2013
18 Jun
Discontinued Application: 91300

Drug Name

RILUZOLE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2013-06-18

91300 / 1

Active Ingredient

RILUZOLE

Application Number

91300

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2013-06-18

Regulatory Status

Discontinued

2025
14 Nov
Discontinued Application: 208579

Drug Name

RIVAROXABAN

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2025-11-14

208579 / 1

Active Ingredient

RIVAROXABAN

Application Number

208579

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2025-11-14

Regulatory Status

Discontinued

2025
14 Nov
Discontinued Application: 208579

Drug Name

RIVAROXABAN

Product Number

2

Dosage Form

-

Strength

15MG

Approval Date

2025-11-14

208579 / 2

Active Ingredient

RIVAROXABAN

Application Number

208579

Product Number

2

Dosage Form

-

Strength

15MG

Approval Date

2025-11-14

Regulatory Status

Discontinued

2025
14 Nov
Discontinued Application: 208579

Drug Name

RIVAROXABAN

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2025-11-14

208579 / 3

Active Ingredient

RIVAROXABAN

Application Number

208579

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2025-11-14

Regulatory Status

Discontinued

2016
19 Jul
Discontinued Application: 79145

Drug Name

ROSUVASTATIN CALCIUM

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2016-07-19

79145 / 1

Active Ingredient

ROSUVASTATIN CALCIUM

Application Number

79145

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2016-07-19

Regulatory Status

Discontinued

2016
19 Jul
Discontinued Application: 79145

Drug Name

ROSUVASTATIN CALCIUM

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2016-07-19

79145 / 2

Active Ingredient

ROSUVASTATIN CALCIUM

Application Number

79145

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2016-07-19

Regulatory Status

Discontinued

2016
19 Jul
Discontinued Application: 79145

Drug Name

ROSUVASTATIN CALCIUM

Product Number

3

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2016-07-19

79145 / 3

Active Ingredient

ROSUVASTATIN CALCIUM

Application Number

79145

Product Number

3

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2016-07-19

Regulatory Status

Discontinued

2016
19 Jul
Discontinued Application: 79145

Drug Name

ROSUVASTATIN CALCIUM

Product Number

4

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2016-07-19

79145 / 4

Active Ingredient

ROSUVASTATIN CALCIUM

Application Number

79145

Product Number

4

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2016-07-19

Regulatory Status

Discontinued

2012
06 Nov
Discontinued Application: 91379

Drug Name

SILDENAFIL CITRATE

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2012-11-06

91379 / 1

Active Ingredient

SILDENAFIL CITRATE

Application Number

91379

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2012-11-06

Regulatory Status

Discontinued

2025
27 Jan
Discontinued Application: 212228

Drug Name

SORAFENIB TOSYLATE

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2025-01-27

212228 / 1

Active Ingredient

SORAFENIB TOSYLATE

Application Number

212228

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2025-01-27

Regulatory Status

Discontinued

2011
23 Sep
Discontinued Application: 90878

Drug Name

TAMOXIFEN CITRATE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2011-09-23

90878 / 1

Active Ingredient

TAMOXIFEN CITRATE

Application Number

90878

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2011-09-23

Regulatory Status

Discontinued

2011
23 Sep
Discontinued Application: 90878

Drug Name

TAMOXIFEN CITRATE

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2011-09-23

90878 / 2

Active Ingredient

TAMOXIFEN CITRATE

Application Number

90878

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2011-09-23

Regulatory Status

Discontinued

2018
05 Jul
Discontinued Application: 204159

Drug Name

TEMOZOLOMIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2018-07-05

204159 / 1

Active Ingredient

TEMOZOLOMIDE

Application Number

204159

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2018-07-05

Regulatory Status

Discontinued

2018
05 Jul
Discontinued Application: 204159

Drug Name

TEMOZOLOMIDE

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2018-07-05

204159 / 2

Active Ingredient

TEMOZOLOMIDE

Application Number

204159

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2018-07-05

Regulatory Status

Discontinued

2018
05 Jul
Discontinued Application: 204159

Drug Name

TEMOZOLOMIDE

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2018-07-05

204159 / 3

Active Ingredient

TEMOZOLOMIDE

Application Number

204159

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2018-07-05

Regulatory Status

Discontinued

2018
05 Jul
Discontinued Application: 204159

Drug Name

TEMOZOLOMIDE

Product Number

4

Dosage Form

-

Strength

140MG

Approval Date

2018-07-05

204159 / 4

Active Ingredient

TEMOZOLOMIDE

Application Number

204159

Product Number

4

Dosage Form

-

Strength

140MG

Approval Date

2018-07-05

Regulatory Status

Discontinued

2018
05 Jul
Discontinued Application: 204159

Drug Name

TEMOZOLOMIDE

Product Number

5

Dosage Form

-

Strength

180MG

Approval Date

2018-07-05

204159 / 5

Active Ingredient

TEMOZOLOMIDE

Application Number

204159

Product Number

5

Dosage Form

-

Strength

180MG

Approval Date

2018-07-05

Regulatory Status

Discontinued

2018
05 Jul
Discontinued Application: 204159

Drug Name

TEMOZOLOMIDE

Product Number

6

Dosage Form

-

Strength

250MG

Approval Date

2018-07-05

204159 / 6

Active Ingredient

TEMOZOLOMIDE

Application Number

204159

Product Number

6

Dosage Form

-

Strength

250MG

Approval Date

2018-07-05

Regulatory Status

Discontinued

2024
21 Mar
Discontinued Application: 213867

Drug Name

TENOFOVIR ALAFENAMIDE FUMARATE

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2024-03-21

213867 / 1

Active Ingredient

TENOFOVIR ALAFENAMIDE FUMARATE

Application Number

213867

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2024-03-21

Regulatory Status

Discontinued

2018
02 Nov
Discontinued Application: 209601

Drug Name

TERIFLUNOMIDE

Product Number

1

Dosage Form

-

Strength

7MG

Approval Date

2018-11-02

209601 / 1

Active Ingredient

TERIFLUNOMIDE

Application Number

209601

Product Number

1

Dosage Form

-

Strength

7MG

Approval Date

2018-11-02

Regulatory Status

Discontinued

2018
02 Nov
Discontinued Application: 209601

Drug Name

TERIFLUNOMIDE

Product Number

2

Dosage Form

-

Strength

14MG

Approval Date

2018-11-02

209601 / 2

Active Ingredient

TERIFLUNOMIDE

Application Number

209601

Product Number

2

Dosage Form

-

Strength

14MG

Approval Date

2018-11-02

Regulatory Status

Discontinued

2020
25 Nov
Discontinued Application: 209181

Drug Name

TESTOSTERONE

Product Number

1

Dosage Form

-

Strength

30MG/1.5ML ACTUATION

Approval Date

2020-11-25

209181 / 1

Active Ingredient

TESTOSTERONE

Application Number

209181

Product Number

1

Dosage Form

-

Strength

30MG/1.5ML ACTUATION

Approval Date

2020-11-25

Regulatory Status

Discontinued

1999
01 Jul
Discontinued Application: 75089

Drug Name

TICLOPIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1999-07-01

75089 / 1

Active Ingredient

TICLOPIDINE HYDROCHLORIDE

Application Number

75089

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1999-07-01

Regulatory Status

Discontinued

2015
17 Apr
Discontinued Application: 204936

Drug Name

TIMOLOL MALEATE

Product Number

1

Dosage Form

-

Strength

EQ 0.5% BASE

Approval Date

2015-04-17

204936 / 1

Active Ingredient

TIMOLOL MALEATE

Application Number

204936

Product Number

1

Dosage Form

-

Strength

EQ 0.5% BASE

Approval Date

2015-04-17

Regulatory Status

Discontinued

2012
25 Sep
Discontinued Application: 200164

Drug Name

TOLTERODINE TARTRATE

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2012-09-25

200164 / 1

Active Ingredient

TOLTERODINE TARTRATE

Application Number

200164

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2012-09-25

Regulatory Status

Discontinued

2012
25 Sep
Discontinued Application: 200164

Drug Name

TOLTERODINE TARTRATE

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2012-09-25

200164 / 2

Active Ingredient

TOLTERODINE TARTRATE

Application Number

200164

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2012-09-25

Regulatory Status

Discontinued

2002
10 Jul
Discontinued Application: 75981

Drug Name

TRAMADOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2002-07-10

75981 / 1

Active Ingredient

TRAMADOL HYDROCHLORIDE

Application Number

75981

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2002-07-10

Regulatory Status

Discontinued

2014
27 Jan
Discontinued Application: 202286

Drug Name

TRANEXAMIC ACID

Product Number

1

Dosage Form

-

Strength

650MG

Approval Date

2014-01-27

202286 / 1

Active Ingredient

TRANEXAMIC ACID

Application Number

202286

Product Number

1

Dosage Form

-

Strength

650MG

Approval Date

2014-01-27

Regulatory Status

Discontinued

2014
04 Apr
Discontinued Application: 90500

Drug Name

VALACYCLOVIR HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2014-04-04

90500 / 1

Active Ingredient

VALACYCLOVIR HYDROCHLORIDE

Application Number

90500

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2014-04-04

Regulatory Status

Discontinued

2014
04 Apr
Discontinued Application: 90500

Drug Name

VALACYCLOVIR HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE

Approval Date

2014-04-04

90500 / 2

Active Ingredient

VALACYCLOVIR HYDROCHLORIDE

Application Number

90500

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE

Approval Date

2014-04-04

Regulatory Status

Discontinued

2005
29 Dec
Discontinued Application: 21697

Drug Name

VAPRISOL

Product Number

1

Dosage Form

-

Strength

20MG/4ML (5MG/ML)

Approval Date

2005-12-29

21697 / 1

Active Ingredient

CONIVAPTAN HYDROCHLORIDE

Application Number

21697

Product Number

1

Dosage Form

-

Strength

20MG/4ML (5MG/ML)

Approval Date

2005-12-29

Regulatory Status

Discontinued

2012
20 Apr
Discontinued Application: 200878

Drug Name

VERAPAMIL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

120MG

Approval Date

2012-04-20

200878 / 1

Active Ingredient

VERAPAMIL HYDROCHLORIDE

Application Number

200878

Product Number

1

Dosage Form

-

Strength

120MG

Approval Date

2012-04-20

Regulatory Status

Discontinued

2012
20 Apr
Discontinued Application: 200878

Drug Name

VERAPAMIL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

180MG

Approval Date

2012-04-20

200878 / 2

Active Ingredient

VERAPAMIL HYDROCHLORIDE

Application Number

200878

Product Number

2

Dosage Form

-

Strength

180MG

Approval Date

2012-04-20

Regulatory Status

Discontinued

2012
20 Apr
Discontinued Application: 200878

Drug Name

VERAPAMIL HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

240MG

Approval Date

2012-04-20

200878 / 3

Active Ingredient

VERAPAMIL HYDROCHLORIDE

Application Number

200878

Product Number

3

Dosage Form

-

Strength

240MG

Approval Date

2012-04-20

Regulatory Status

Discontinued

2009
11 Sep
Discontinued Application: 22110

Drug Name

VIBATIV

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE/VIAL

Approval Date

2009-09-11

22110 / 1

Active Ingredient

TELAVANCIN HYDROCHLORIDE

Application Number

22110

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE/VIAL

Approval Date

2009-09-11

Regulatory Status

Discontinued

2015
24 Dec
Discontinued Application: 204367

Drug Name

ZOLEDRONIC ACID

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/100ML

Approval Date

2015-12-24

204367 / 1

Active Ingredient

ZOLEDRONIC ACID

Application Number

204367

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/100ML

Approval Date

2015-12-24

Regulatory Status

Discontinued

2013
10 Sep
Discontinued Application: 200266

Drug Name

ZOLPIDEM TARTRATE

Product Number

1

Dosage Form

-

Strength

6.25MG

Approval Date

2013-09-10

200266 / 1

Active Ingredient

ZOLPIDEM TARTRATE

Application Number

200266

Product Number

1

Dosage Form

-

Strength

6.25MG

Approval Date

2013-09-10

Regulatory Status

Discontinued

2013
10 Sep
Discontinued Application: 200266

Drug Name

ZOLPIDEM TARTRATE

Product Number

2

Dosage Form

-

Strength

12.5MG

Approval Date

2013-09-10

200266 / 2

Active Ingredient

ZOLPIDEM TARTRATE

Application Number

200266

Product Number

2

Dosage Form

-

Strength

12.5MG

Approval Date

2013-09-10

Regulatory Status

Discontinued

2005
22 Dec
Discontinued Application: 77642

Drug Name

ZONISAMIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2005-12-22

77642 / 1

Active Ingredient

ZONISAMIDE

Application Number

77642

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2005-12-22

Regulatory Status

Discontinued

2005
22 Dec
Discontinued Application: 77642

Drug Name

ZONISAMIDE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2005-12-22

77642 / 2

Active Ingredient

ZONISAMIDE

Application Number

77642

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2005-12-22

Regulatory Status

Discontinued

2005
22 Dec
Discontinued Application: 77642

Drug Name

ZONISAMIDE

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2005-12-22

77642 / 3

Active Ingredient

ZONISAMIDE

Application Number

77642

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2005-12-22

Regulatory Status

Discontinued

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Drug Status Breakdown
263 total
  • Discontinued
Official Source

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

Visit FDA Orange Book
FDA Approved Drug Record Details Preview

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

Drug Name

ACYCLOVIR

Application Number

210774

Product Number

1

Active Ingredient

ACYCLOVIR

Dosage Form

-

Strength

5%

FDA Approved Drug Data

Approved drug product information

Regular Updates

Data maintained from official sources

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Searchable pharmaceutical data

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Organized FDA drug records

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