Glenmark Pharmaceuticals
FDA Approved Drugs

Glenmark Pharmaceuticals

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.

RX OTC Unclassified Discontinued
  • Total Records 84
  • Latest Approval Date Apr 08, 2026
  • Data Source FDA
  • First Approval Date Feb 05, 1991
All
84
View
Unclassified
5
View
Discontinued
22
View
OTC
10
View
RX
47
View
Company Overview

Company

Glenmark Pharmaceuticals

Country

India

Website

Visit Website

Email

india_marketing@glenmarkpharma.com

Social Profiles

Company Snapshot

Glenmark Pharmaceuticals

Glenmark House, B. D. Sawant Marg, Chakala, Off Western Express Highway, Andheri (E), Mumbai - 400 099

India

www.glenmarkpharma.com/ india_marketing@glenmarkpharma.com View on Map
FDA Approved Drug Records ( 84 records )
2019
16 Oct
RX Application: 209227

Drug Name

ABIRATERONE ACETATE

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2019-10-16

209227 / 1

Active Ingredient

ABIRATERONE ACETATE

Application Number

209227

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2019-10-16

Regulatory Status

RX

2022
19 May
RX Application: 209227

Drug Name

ABIRATERONE ACETATE

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2022-05-19

209227 / 2

Active Ingredient

ABIRATERONE ACETATE

Application Number

209227

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2022-05-19

Regulatory Status

RX

2022
03 Feb
RX Application: 213693

Drug Name

ACETYLCYSTEINE

Product Number

1

Dosage Form

-

Strength

6GM/30ML (200MG/ML)

Approval Date

2022-02-03

213693 / 1

Active Ingredient

ACETYLCYSTEINE

Application Number

213693

Product Number

1

Dosage Form

-

Strength

6GM/30ML (200MG/ML)

Approval Date

2022-02-03

Regulatory Status

RX

2017
31 Jul
RX Application: 205510

Drug Name

ACYCLOVIR

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

2017-07-31

205510 / 1

Active Ingredient

ACYCLOVIR

Application Number

205510

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

2017-07-31

Regulatory Status

RX

2010
01 Jul
OTC Application: 91314

Drug Name

ADAPALENE

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

2010-07-01

91314 / 1

Active Ingredient

ADAPALENE

Application Number

91314

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

2010-07-01

Regulatory Status

OTC

-
Unclassified Application: 91314

Drug Name

ADAPALENE

Product Number

2

Dosage Form

-

Strength

0.1%

Approval Date

-

91314 / 2

Active Ingredient

ADAPALENE

Application Number

91314

Product Number

2

Dosage Form

-

Strength

0.1%

Approval Date

-

Regulatory Status

Unclassified

2017
12 Oct
RX Application: 207777

Drug Name

APREPITANT

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2017-10-12

207777 / 1

Active Ingredient

APREPITANT

Application Number

207777

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2017-10-12

Regulatory Status

RX

2017
12 Oct
RX Application: 207777

Drug Name

APREPITANT

Product Number

2

Dosage Form

-

Strength

80MG

Approval Date

2017-10-12

207777 / 2

Active Ingredient

APREPITANT

Application Number

207777

Product Number

2

Dosage Form

-

Strength

80MG

Approval Date

2017-10-12

Regulatory Status

RX

2017
12 Oct
RX Application: 207777

Drug Name

APREPITANT

Product Number

3

Dosage Form

-

Strength

125MG

Approval Date

2017-10-12

207777 / 3

Active Ingredient

APREPITANT

Application Number

207777

Product Number

3

Dosage Form

-

Strength

125MG

Approval Date

2017-10-12

Regulatory Status

RX

2019
24 May
RX Application: 210318

Drug Name

ASPIRIN AND DIPYRIDAMOLE

Product Number

1

Dosage Form

-

Strength

25MG;200MG

Approval Date

2019-05-24

210318 / 1

Active Ingredient

ASPIRIN; DIPYRIDAMOLE

Application Number

210318

Product Number

1

Dosage Form

-

Strength

25MG;200MG

Approval Date

2019-05-24

Regulatory Status

RX

2018
21 Nov
RX Application: 209685

Drug Name

ATOVAQUONE

Product Number

1

Dosage Form

-

Strength

750MG/5ML

Approval Date

2018-11-21

209685 / 1

Active Ingredient

ATOVAQUONE

Application Number

209685

Product Number

1

Dosage Form

-

Strength

750MG/5ML

Approval Date

2018-11-21

Regulatory Status

RX

2018
19 Nov
RX Application: 204637

Drug Name

AZELAIC ACID

Product Number

1

Dosage Form

-

Strength

15%

Approval Date

2018-11-19

204637 / 1

Active Ingredient

AZELAIC ACID

Application Number

204637

Product Number

1

Dosage Form

-

Strength

15%

Approval Date

2018-11-19

Regulatory Status

RX

2008
23 Sep
Discontinued Application: 78930

Drug Name

BETAMETHASONE DIPROPIONATE

Product Number

1

Dosage Form

-

Strength

EQ 0.05% BASE

Approval Date

2008-09-23

78930 / 1

Active Ingredient

BETAMETHASONE DIPROPIONATE

Application Number

78930

Product Number

1

Dosage Form

-

Strength

EQ 0.05% BASE

Approval Date

2008-09-23

Regulatory Status

Discontinued

2010
24 Mar
RX Application: 90633

Drug Name

CALCIPOTRIENE

Product Number

1

Dosage Form

-

Strength

0.005%

Approval Date

2010-03-24

90633 / 1

Active Ingredient

CALCIPOTRIENE

Application Number

90633

Product Number

1

Dosage Form

-

Strength

0.005%

Approval Date

2010-03-24

Regulatory Status

RX

2015
09 Jun
RX Application: 205772

Drug Name

CALCIPOTRIENE

Product Number

1

Dosage Form

-

Strength

0.005%

Approval Date

2015-06-09

205772 / 1

Active Ingredient

CALCIPOTRIENE

Application Number

205772

Product Number

1

Dosage Form

-

Strength

0.005%

Approval Date

2015-06-09

Regulatory Status

RX

2007
28 Dec
OTC Application: 78427

Drug Name

CETIRIZINE HYDROCHLORIDE ALLERGY

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

2007-12-28

78427 / 3

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

78427

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

2007-12-28

Regulatory Status

OTC

2007
28 Dec
OTC Application: 78427

Drug Name

CETIRIZINE HYDROCHLORIDE ALLERGY

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2007-12-28

78427 / 4

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

78427

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2007-12-28

Regulatory Status

OTC

2009
10 Nov
RX Application: 90273

Drug Name

CICLOPIROX

Product Number

1

Dosage Form

-

Strength

0.77%

Approval Date

2009-11-10

90273 / 1

Active Ingredient

CICLOPIROX

Application Number

90273

Product Number

1

Dosage Form

-

Strength

0.77%

Approval Date

2009-11-10

Regulatory Status

RX

2012
29 Feb
RX Application: 91595

Drug Name

CICLOPIROX

Product Number

1

Dosage Form

-

Strength

0.77%

Approval Date

2012-02-29

91595 / 1

Active Ingredient

CICLOPIROX

Application Number

91595

Product Number

1

Dosage Form

-

Strength

0.77%

Approval Date

2012-02-29

Regulatory Status

RX

2019
14 Mar
RX Application: 209252

Drug Name

CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE

Product Number

1

Dosage Form

-

Strength

5%;EQ 1% BASE

Approval Date

2019-03-14

209252 / 1

Active Ingredient

BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE

Application Number

209252

Product Number

1

Dosage Form

-

Strength

5%;EQ 1% BASE

Approval Date

2019-03-14

Regulatory Status

RX

2017
20 Mar
Discontinued Application: 208933

Drug Name

CLOBETASOL PROPIONATE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2017-03-20

208933 / 1

Active Ingredient

CLOBETASOL PROPIONATE

Application Number

208933

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2017-03-20

Regulatory Status

Discontinued

2018
26 Mar
Discontinued Application: 209004

Drug Name

CLOBETASOL PROPIONATE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2018-03-26

209004 / 1

Active Ingredient

CLOBETASOL PROPIONATE

Application Number

209004

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2018-03-26

Regulatory Status

Discontinued

2018
10 May
Discontinued Application: 209095

Drug Name

CLOBETASOL PROPIONATE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2018-05-10

209095 / 1

Active Ingredient

CLOBETASOL PROPIONATE

Application Number

209095

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2018-05-10

Regulatory Status

Discontinued

2010
03 Aug
RX Application: 90219

Drug Name

CLOTRIMAZOLE

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

2010-08-03

90219 / 1

Active Ingredient

CLOTRIMAZOLE

Application Number

90219

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

2010-08-03

Regulatory Status

RX

2015
30 Oct
Discontinued Application: 202894

Drug Name

CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE

Product Number

1

Dosage Form

-

Strength

EQ 0.05% BASE;1%

Approval Date

2015-10-30

202894 / 1

Active Ingredient

BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE

Application Number

202894

Product Number

1

Dosage Form

-

Strength

EQ 0.05% BASE;1%

Approval Date

2015-10-30

Regulatory Status

Discontinued

-
Unclassified Application: 211564

Drug Name

DAPAGLIFLOZIN

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

-

211564 / 1

Active Ingredient

DAPAGLIFLOZIN

Application Number

211564

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 211564

Drug Name

DAPAGLIFLOZIN

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

-

211564 / 2

Active Ingredient

DAPAGLIFLOZIN

Application Number

211564

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

-

Regulatory Status

Unclassified

2020
06 Jan
RX Application: 209433

Drug Name

DEFERASIROX

Product Number

1

Dosage Form

-

Strength

125MG

Approval Date

2020-01-06

209433 / 1

Active Ingredient

DEFERASIROX

Application Number

209433

Product Number

1

Dosage Form

-

Strength

125MG

Approval Date

2020-01-06

Regulatory Status

RX

2020
06 Jan
RX Application: 209433

Drug Name

DEFERASIROX

Product Number

2

Dosage Form

-

Strength

250MG

Approval Date

2020-01-06

209433 / 2

Active Ingredient

DEFERASIROX

Application Number

209433

Product Number

2

Dosage Form

-

Strength

250MG

Approval Date

2020-01-06

Regulatory Status

RX

2020
06 Jan
RX Application: 209433

Drug Name

DEFERASIROX

Product Number

3

Dosage Form

-

Strength

500MG

Approval Date

2020-01-06

209433 / 3

Active Ingredient

DEFERASIROX

Application Number

209433

Product Number

3

Dosage Form

-

Strength

500MG

Approval Date

2020-01-06

Regulatory Status

RX

-
Unclassified Application: 78362

Drug Name

DESLORATADINE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

-

78362 / 1

Active Ingredient

DESLORATADINE

Application Number

78362

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

-

Regulatory Status

Unclassified

2017
26 Sep
Discontinued Application: 209494

Drug Name

DESONIDE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2017-09-26

209494 / 1

Active Ingredient

DESONIDE

Application Number

209494

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2017-09-26

Regulatory Status

Discontinued

2017
24 Jul
Discontinued Application: 209729

Drug Name

DESONIDE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2017-07-24

209729 / 1

Active Ingredient

DESONIDE

Application Number

209729

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2017-07-24

Regulatory Status

Discontinued

1991
05 Feb
Discontinued Application: 88999

Drug Name

DIPYRIDAMOLE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1991-02-05

88999 / 1

Active Ingredient

DIPYRIDAMOLE

Application Number

88999

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1991-02-05

Regulatory Status

Discontinued

1991
05 Feb
Discontinued Application: 89000

Drug Name

DIPYRIDAMOLE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1991-02-05

89000 / 1

Active Ingredient

DIPYRIDAMOLE

Application Number

89000

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1991-02-05

Regulatory Status

Discontinued

1991
05 Feb
Discontinued Application: 89001

Drug Name

DIPYRIDAMOLE

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

1991-02-05

89001 / 1

Active Ingredient

DIPYRIDAMOLE

Application Number

89001

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

1991-02-05

Regulatory Status

Discontinued

-
Unclassified Application: 205903

Drug Name

DRONEDARONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

-

205903 / 1

Active Ingredient

DRONEDARONE HYDROCHLORIDE

Application Number

205903

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

-

Regulatory Status

Unclassified

2025
05 Aug
RX Application: 218142

Drug Name

ERIBULIN MESYLATE

Product Number

1

Dosage Form

-

Strength

1MG/2ML (0.5MG/ML)

Approval Date

2025-08-05

218142 / 1

Active Ingredient

ERIBULIN MESYLATE

Application Number

218142

Product Number

1

Dosage Form

-

Strength

1MG/2ML (0.5MG/ML)

Approval Date

2025-08-05

Regulatory Status

RX

2019
10 May
Discontinued Application: 209495

Drug Name

ESOMEPRAZOLE MAGNESIUM

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2019-05-10

209495 / 1

Active Ingredient

ESOMEPRAZOLE MAGNESIUM

Application Number

209495

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2019-05-10

Regulatory Status

Discontinued

2019
10 May
Discontinued Application: 209495

Drug Name

ESOMEPRAZOLE MAGNESIUM

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2019-05-10

209495 / 2

Active Ingredient

ESOMEPRAZOLE MAGNESIUM

Application Number

209495

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2019-05-10

Regulatory Status

Discontinued

2024
11 Jun
OTC Application: 218092

Drug Name

ESOMEPRAZOLE MAGNESIUM

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2024-06-11

218092 / 1

Active Ingredient

ESOMEPRAZOLE MAGNESIUM

Application Number

218092

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2024-06-11

Regulatory Status

OTC

2005
07 Mar
OTC Application: 77146

Drug Name

FAMOTIDINE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2005-03-07

77146 / 1

Active Ingredient

FAMOTIDINE

Application Number

77146

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2005-03-07

Regulatory Status

OTC

2010
04 Aug
OTC Application: 90837

Drug Name

FAMOTIDINE

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2010-08-04

90837 / 1

Active Ingredient

FAMOTIDINE

Application Number

90837

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2010-08-04

Regulatory Status

OTC

2026
16 Mar
OTC Application: 218742

Drug Name

FLUTICASONE PROPIONATE

Product Number

1

Dosage Form

-

Strength

0.05MG/SPRAY

Approval Date

2026-03-16

218742 / 1

Active Ingredient

FLUTICASONE PROPIONATE

Application Number

218742

Product Number

1

Dosage Form

-

Strength

0.05MG/SPRAY

Approval Date

2026-03-16

Regulatory Status

OTC

2026
03 Mar
RX Application: 219602

Drug Name

FLUTICASONE PROPIONATE

Product Number

1

Dosage Form

-

Strength

0.044MG/INH

Approval Date

2026-03-03

219602 / 1

Active Ingredient

FLUTICASONE PROPIONATE

Application Number

219602

Product Number

1

Dosage Form

-

Strength

0.044MG/INH

Approval Date

2026-03-03

Regulatory Status

RX

2019
22 Aug
RX Application: 207754

Drug Name

FULVESTRANT

Product Number

1

Dosage Form

-

Strength

250MG/5ML (50MG/ML)

Approval Date

2019-08-22

207754 / 1

Active Ingredient

FULVESTRANT

Application Number

207754

Product Number

1

Dosage Form

-

Strength

250MG/5ML (50MG/ML)

Approval Date

2019-08-22

Regulatory Status

RX

2018
05 Jun
RX Application: 209297

Drug Name

HAILEY 1.5/30

Product Number

1

Dosage Form

-

Strength

0.03MG;1.5MG

Approval Date

2018-06-05

209297 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Application Number

209297

Product Number

1

Dosage Form

-

Strength

0.03MG;1.5MG

Approval Date

2018-06-05

Regulatory Status

RX

2018
05 Jun
RX Application: 209031

Drug Name

HAILEY FE 1.5/30

Product Number

1

Dosage Form

-

Strength

0.03MG;1.5MG

Approval Date

2018-06-05

209031 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Application Number

209031

Product Number

1

Dosage Form

-

Strength

0.03MG;1.5MG

Approval Date

2018-06-05

Regulatory Status

RX

2012
06 Mar
RX Application: 201994

Drug Name

IMIQUIMOD

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

2012-03-06

201994 / 1

Active Ingredient

IMIQUIMOD

Application Number

201994

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

2012-03-06

Regulatory Status

RX

2026
21 Jan
RX Application: 220268

Drug Name

LACOSAMIDE

Product Number

1

Dosage Form

-

Strength

200MG/20ML (10MG/ML)

Approval Date

2026-01-21

220268 / 1

Active Ingredient

LACOSAMIDE

Application Number

220268

Product Number

1

Dosage Form

-

Strength

200MG/20ML (10MG/ML)

Approval Date

2026-01-21

Regulatory Status

RX

2012
18 May
OTC Application: 202727

Drug Name

LANSOPRAZOLE

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2012-05-18

202727 / 1

Active Ingredient

LANSOPRAZOLE

Application Number

202727

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2012-05-18

Regulatory Status

OTC

2015
21 Dec
RX Application: 78987

Drug Name

LINEZOLID

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2015-12-21

78987 / 1

Active Ingredient

LINEZOLID

Application Number

78987

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2015-12-21

Regulatory Status

RX

2010
27 Dec
RX Application: 91544

Drug Name

LITHIUM CARBONATE

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

2010-12-27

91544 / 1

Active Ingredient

LITHIUM CARBONATE

Application Number

91544

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

2010-12-27

Regulatory Status

RX

2010
17 Mar
Discontinued Application: 90718

Drug Name

MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

12.5MG;7.5MG

Approval Date

2010-03-17

90718 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE

Application Number

90718

Product Number

1

Dosage Form

-

Strength

12.5MG;7.5MG

Approval Date

2010-03-17

Regulatory Status

Discontinued

2010
17 Mar
Discontinued Application: 90718

Drug Name

MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

12.5MG;15MG

Approval Date

2010-03-17

90718 / 2

Active Ingredient

HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE

Application Number

90718

Product Number

2

Dosage Form

-

Strength

12.5MG;15MG

Approval Date

2010-03-17

Regulatory Status

Discontinued

2010
17 Mar
Discontinued Application: 90718

Drug Name

MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

Product Number

3

Dosage Form

-

Strength

25MG;15MG

Approval Date

2010-03-17

90718 / 3

Active Ingredient

HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE

Application Number

90718

Product Number

3

Dosage Form

-

Strength

25MG;15MG

Approval Date

2010-03-17

Regulatory Status

Discontinued

2008
28 May
Discontinued Application: 78541

Drug Name

MOMETASONE FUROATE

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

2008-05-28

78541 / 1

Active Ingredient

MOMETASONE FUROATE

Application Number

78541

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

2008-05-28

Regulatory Status

Discontinued

2008
28 May
Discontinued Application: 78571

Drug Name

MOMETASONE FUROATE

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

2008-05-28

78571 / 1

Active Ingredient

MOMETASONE FUROATE

Application Number

78571

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

2008-05-28

Regulatory Status

Discontinued

2011
08 Jun
RX Application: 90480

Drug Name

MUPIROCIN

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

2011-06-08

90480 / 1

Active Ingredient

MUPIROCIN

Application Number

90480

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

2011-06-08

Regulatory Status

RX

2013
24 Jan
RX Application: 201587

Drug Name

MUPIROCIN

Product Number

1

Dosage Form

-

Strength

EQ 2% BASE

Approval Date

2013-01-24

201587 / 1

Active Ingredient

MUPIROCIN CALCIUM

Application Number

201587

Product Number

1

Dosage Form

-

Strength

EQ 2% BASE

Approval Date

2013-01-24

Regulatory Status

RX

2017
19 Sep
RX Application: 206391

Drug Name

NITROGLYCERIN

Product Number

1

Dosage Form

-

Strength

0.3MG

Approval Date

2017-09-19

206391 / 1

Active Ingredient

NITROGLYCERIN

Application Number

206391

Product Number

1

Dosage Form

-

Strength

0.3MG

Approval Date

2017-09-19

Regulatory Status

RX

2017
19 Sep
RX Application: 206391

Drug Name

NITROGLYCERIN

Product Number

2

Dosage Form

-

Strength

0.4MG

Approval Date

2017-09-19

206391 / 2

Active Ingredient

NITROGLYCERIN

Application Number

206391

Product Number

2

Dosage Form

-

Strength

0.4MG

Approval Date

2017-09-19

Regulatory Status

RX

2017
19 Sep
RX Application: 206391

Drug Name

NITROGLYCERIN

Product Number

3

Dosage Form

-

Strength

0.6MG

Approval Date

2017-09-19

206391 / 3

Active Ingredient

NITROGLYCERIN

Application Number

206391

Product Number

3

Dosage Form

-

Strength

0.6MG

Approval Date

2017-09-19

Regulatory Status

RX

2011
15 Jul
Discontinued Application: 90618

Drug Name

NIZATIDINE

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2011-07-15

90618 / 1

Active Ingredient

NIZATIDINE

Application Number

90618

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2011-07-15

Regulatory Status

Discontinued

2011
15 Jul
Discontinued Application: 90618

Drug Name

NIZATIDINE

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2011-07-15

90618 / 2

Active Ingredient

NIZATIDINE

Application Number

90618

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2011-07-15

Regulatory Status

Discontinued

2016
23 Feb
RX Application: 204057

Drug Name

NORGESTIMATE AND ETHINYL ESTRADIOL

Product Number

1

Dosage Form

-

Strength

0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG

Approval Date

2016-02-23

204057 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORGESTIMATE

Application Number

204057

Product Number

1

Dosage Form

-

Strength

0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG

Approval Date

2016-02-23

Regulatory Status

RX

2017
28 Jun
OTC Application: 200810

Drug Name

OLOPATADINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 0.1% BASE

Approval Date

2017-06-28

200810 / 1

Active Ingredient

OLOPATADINE HYDROCHLORIDE

Application Number

200810

Product Number

1

Dosage Form

-

Strength

EQ 0.1% BASE

Approval Date

2017-06-28

Regulatory Status

OTC

2025
28 Feb
OTC Application: 219557

Drug Name

OLOPATADINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 0.2% BASE

Approval Date

2025-02-28

219557 / 1

Active Ingredient

OLOPATADINE HYDROCHLORIDE

Application Number

219557

Product Number

1

Dosage Form

-

Strength

EQ 0.2% BASE

Approval Date

2025-02-28

Regulatory Status

OTC

2026
08 Apr
RX Application: 216363

Drug Name

PROGESTERONE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2026-04-08

216363 / 1

Active Ingredient

PROGESTERONE

Application Number

216363

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2026-04-08

Regulatory Status

RX

2008
19 Nov
Discontinued Application: 78542

Drug Name

RANITIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2008-11-19

78542 / 1

Active Ingredient

RANITIDINE HYDROCHLORIDE

Application Number

78542

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2008-11-19

Regulatory Status

Discontinued

2008
19 Nov
Discontinued Application: 78542

Drug Name

RANITIDINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

2008-11-19

78542 / 2

Active Ingredient

RANITIDINE HYDROCHLORIDE

Application Number

78542

Product Number

2

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

2008-11-19

Regulatory Status

Discontinued

2016
19 Jul
RX Application: 79172

Drug Name

ROSUVASTATIN CALCIUM

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2016-07-19

79172 / 1

Active Ingredient

ROSUVASTATIN CALCIUM

Application Number

79172

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2016-07-19

Regulatory Status

RX

2016
19 Jul
RX Application: 79172

Drug Name

ROSUVASTATIN CALCIUM

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2016-07-19

79172 / 2

Active Ingredient

ROSUVASTATIN CALCIUM

Application Number

79172

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2016-07-19

Regulatory Status

RX

2016
19 Jul
RX Application: 79172

Drug Name

ROSUVASTATIN CALCIUM

Product Number

3

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2016-07-19

79172 / 3

Active Ingredient

ROSUVASTATIN CALCIUM

Application Number

79172

Product Number

3

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2016-07-19

Regulatory Status

RX

2016
19 Jul
RX Application: 79172

Drug Name

ROSUVASTATIN CALCIUM

Product Number

4

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2016-07-19

79172 / 4

Active Ingredient

ROSUVASTATIN CALCIUM

Application Number

79172

Product Number

4

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2016-07-19

Regulatory Status

RX

2022
13 Jan
RX Application: 211746

Drug Name

RYALTRIS

Product Number

1

Dosage Form

-

Strength

0.025MG/SPRAY;0.665MG/SPRAY

Approval Date

2022-01-13

211746 / 1

Active Ingredient

MOMETASONE FUROATE; OLOPATADINE HYDROCHLORIDE

Application Number

211746

Product Number

1

Dosage Form

-

Strength

0.025MG/SPRAY;0.665MG/SPRAY

Approval Date

2022-01-13

Regulatory Status

RX

2019
20 May
RX Application: 209239

Drug Name

SOLIFENACIN SUCCINATE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2019-05-20

209239 / 1

Active Ingredient

SOLIFENACIN SUCCINATE

Application Number

209239

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2019-05-20

Regulatory Status

RX

2019
20 May
RX Application: 209239

Drug Name

SOLIFENACIN SUCCINATE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2019-05-20

209239 / 2

Active Ingredient

SOLIFENACIN SUCCINATE

Application Number

209239

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2019-05-20

Regulatory Status

RX

2018
15 Nov
RX Application: 209663

Drug Name

TERIFLUNOMIDE

Product Number

1

Dosage Form

-

Strength

7MG

Approval Date

2018-11-15

209663 / 1

Active Ingredient

TERIFLUNOMIDE

Application Number

209663

Product Number

1

Dosage Form

-

Strength

7MG

Approval Date

2018-11-15

Regulatory Status

RX

2018
15 Nov
RX Application: 209663

Drug Name

TERIFLUNOMIDE

Product Number

2

Dosage Form

-

Strength

14MG

Approval Date

2018-11-15

209663 / 2

Active Ingredient

TERIFLUNOMIDE

Application Number

209663

Product Number

2

Dosage Form

-

Strength

14MG

Approval Date

2018-11-15

Regulatory Status

RX

2017
22 Aug
Discontinued Application: 208320

Drug Name

TRIAMCINOLONE ACETONIDE

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

2017-08-22

208320 / 1

Active Ingredient

TRIAMCINOLONE ACETONIDE

Application Number

208320

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

2017-08-22

Regulatory Status

Discontinued

2006
30 Jan
RX Application: 77651

Drug Name

ZONISAMIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2006-01-30

77651 / 1

Active Ingredient

ZONISAMIDE

Application Number

77651

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2006-01-30

Regulatory Status

RX

2006
30 Jan
RX Application: 77651

Drug Name

ZONISAMIDE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2006-01-30

77651 / 2

Active Ingredient

ZONISAMIDE

Application Number

77651

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2006-01-30

Regulatory Status

RX

2006
30 Jan
RX Application: 77651

Drug Name

ZONISAMIDE

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2006-01-30

77651 / 3

Active Ingredient

ZONISAMIDE

Application Number

77651

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2006-01-30

Regulatory Status

RX

Related Databases
  • FDA Inspections
    25 View
  • EDQM CEP
    2 View
  • KDMF
    0 View
  • Japan DMF
    0 View
  • Eudra GMP
    0 View
  • NDC Database
    0 View
  • FDA Approved Drugs Database
    84 View
  • Drug Prices in Switzerland
    0 View
Drug Status Breakdown
84 total
  • RX
  • OTC
  • Unclassified
  • 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

ABIRATERONE ACETATE

Application Number

209227

Product Number

1

Active Ingredient

ABIRATERONE ACETATE

Dosage Form

-

Strength

250MG

FDA Approved Drug Data

Approved drug product information

Regular Updates

Data maintained from official sources

Structured Database

Searchable pharmaceutical data

Reliable Data

Organized FDA drug records

Create a New Buying Request

Fields marked with * are mandatory.

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