Torrent Pharmaceuticals Limited RX
FDA Approved Drugs

Torrent Pharmaceuticals Limited RX

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
  • Total Records 165
  • Latest Approval Date May 20, 2026
  • Data Source FDA
  • First Approval Date Nov 30, 2000
All
326
View
Unclassified
13
View
Discontinued
148
View
RX
165
View
Company Overview

Company

Torrent Pharmaceuticals Limited RX

Country

India

Website

Visit Website

Email

Social Profiles

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Company Snapshot

Torrent Pharmaceuticals Limited RX

Off. Ashram Road, Ahmedabad - 380 009, Gujarat

India

www.torrentpharma.com/ View on Map
FDA Approved Drug Records ( 165 records )
2019
11 Jan
RX Application: 209971

Drug Name

ACYCLOVIR

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

2019-01-11

209971 / 1

Active Ingredient

ACYCLOVIR

Application Number

209971

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

2019-01-11

Regulatory Status

RX

2017
30 Jun
RX Application: 209151

Drug Name

ANAGRELIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE

Approval Date

2017-06-30

209151 / 1

Active Ingredient

ANAGRELIDE HYDROCHLORIDE

Application Number

209151

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE

Approval Date

2017-06-30

Regulatory Status

RX

2017
30 Jun
RX Application: 209151

Drug Name

ANAGRELIDE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2017-06-30

209151 / 2

Active Ingredient

ANAGRELIDE HYDROCHLORIDE

Application Number

209151

Product Number

2

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2017-06-30

Regulatory Status

RX

2015
28 Apr
RX Application: 201519

Drug Name

ARIPIPRAZOLE

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2015-04-28

201519 / 1

Active Ingredient

ARIPIPRAZOLE

Application Number

201519

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2015-04-28

Regulatory Status

RX

2015
28 Apr
RX Application: 201519

Drug Name

ARIPIPRAZOLE

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2015-04-28

201519 / 2

Active Ingredient

ARIPIPRAZOLE

Application Number

201519

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2015-04-28

Regulatory Status

RX

2015
28 Apr
RX Application: 201519

Drug Name

ARIPIPRAZOLE

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2015-04-28

201519 / 3

Active Ingredient

ARIPIPRAZOLE

Application Number

201519

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2015-04-28

Regulatory Status

RX

2015
28 Apr
RX Application: 201519

Drug Name

ARIPIPRAZOLE

Product Number

4

Dosage Form

-

Strength

15MG

Approval Date

2015-04-28

201519 / 4

Active Ingredient

ARIPIPRAZOLE

Application Number

201519

Product Number

4

Dosage Form

-

Strength

15MG

Approval Date

2015-04-28

Regulatory Status

RX

2015
28 Apr
RX Application: 201519

Drug Name

ARIPIPRAZOLE

Product Number

5

Dosage Form

-

Strength

20MG

Approval Date

2015-04-28

201519 / 5

Active Ingredient

ARIPIPRAZOLE

Application Number

201519

Product Number

5

Dosage Form

-

Strength

20MG

Approval Date

2015-04-28

Regulatory Status

RX

2015
28 Apr
RX Application: 201519

Drug Name

ARIPIPRAZOLE

Product Number

6

Dosage Form

-

Strength

30MG

Approval Date

2015-04-28

201519 / 6

Active Ingredient

ARIPIPRAZOLE

Application Number

201519

Product Number

6

Dosage Form

-

Strength

30MG

Approval Date

2015-04-28

Regulatory Status

RX

2001
05 Jul
RX Application: 75712

Drug Name

CARBAMAZEPINE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2001-07-05

75712 / 1

Active Ingredient

CARBAMAZEPINE

Application Number

75712

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2001-07-05

Regulatory Status

RX

2005
07 Dec
RX Application: 77272

Drug Name

CARBAMAZEPINE

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2005-12-07

77272 / 2

Active Ingredient

CARBAMAZEPINE

Application Number

77272

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2005-12-07

Regulatory Status

RX

2025
13 Jan
RX Application: 212524

Drug Name

CARBAMAZEPINE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2025-01-13

212524 / 1

Active Ingredient

CARBAMAZEPINE

Application Number

212524

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2025-01-13

Regulatory Status

RX

2025
13 Jan
RX Application: 212524

Drug Name

CARBAMAZEPINE

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2025-01-13

212524 / 2

Active Ingredient

CARBAMAZEPINE

Application Number

212524

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2025-01-13

Regulatory Status

RX

2025
13 Jan
RX Application: 212524

Drug Name

CARBAMAZEPINE

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

2025-01-13

212524 / 3

Active Ingredient

CARBAMAZEPINE

Application Number

212524

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

2025-01-13

Regulatory Status

RX

2015
23 Dec
RX Application: 207677

Drug Name

CELECOXIB

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2015-12-23

207677 / 1

Active Ingredient

CELECOXIB

Application Number

207677

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2015-12-23

Regulatory Status

RX

2015
23 Dec
RX Application: 207677

Drug Name

CELECOXIB

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2015-12-23

207677 / 2

Active Ingredient

CELECOXIB

Application Number

207677

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2015-12-23

Regulatory Status

RX

2015
23 Dec
RX Application: 207677

Drug Name

CELECOXIB

Product Number

3

Dosage Form

-

Strength

200MG

Approval Date

2015-12-23

207677 / 3

Active Ingredient

CELECOXIB

Application Number

207677

Product Number

3

Dosage Form

-

Strength

200MG

Approval Date

2015-12-23

Regulatory Status

RX

2015
23 Dec
RX Application: 207677

Drug Name

CELECOXIB

Product Number

4

Dosage Form

-

Strength

400MG

Approval Date

2015-12-23

207677 / 4

Active Ingredient

CELECOXIB

Application Number

207677

Product Number

4

Dosage Form

-

Strength

400MG

Approval Date

2015-12-23

Regulatory Status

RX

2007
27 Mar
RX Application: 78216

Drug Name

CITALOPRAM HYDROBROMIDE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2007-03-27

78216 / 1

Active Ingredient

CITALOPRAM HYDROBROMIDE

Application Number

78216

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2007-03-27

Regulatory Status

RX

2007
27 Mar
RX Application: 78216

Drug Name

CITALOPRAM HYDROBROMIDE

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2007-03-27

78216 / 2

Active Ingredient

CITALOPRAM HYDROBROMIDE

Application Number

78216

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2007-03-27

Regulatory Status

RX

2007
27 Mar
RX Application: 78216

Drug Name

CITALOPRAM HYDROBROMIDE

Product Number

3

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2007-03-27

78216 / 3

Active Ingredient

CITALOPRAM HYDROBROMIDE

Application Number

78216

Product Number

3

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2007-03-27

Regulatory Status

RX

2019
30 Dec
RX Application: 211836

Drug Name

CLOBETASOL PROPIONATE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2019-12-30

211836 / 1

Active Ingredient

CLOBETASOL PROPIONATE

Application Number

211836

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2019-12-30

Regulatory Status

RX

2012
17 May
RX Application: 90844

Drug Name

CLOPIDOGREL BISULFATE

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2012-05-17

90844 / 1

Active Ingredient

CLOPIDOGREL BISULFATE

Application Number

90844

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2012-05-17

Regulatory Status

RX

2026
06 Apr
RX Application: 211537

Drug Name

DAPAGLIFLOZIN AND SAXAGLIPTIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG;EQ 5MG BASE

Approval Date

2026-04-06

211537 / 1

Active Ingredient

DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE

Application Number

211537

Product Number

1

Dosage Form

-

Strength

10MG;EQ 5MG BASE

Approval Date

2026-04-06

Regulatory Status

RX

2022
10 Feb
RX Application: 214722

Drug Name

DAPSONE

Product Number

1

Dosage Form

-

Strength

7.5%

Approval Date

2022-02-10

214722 / 1

Active Ingredient

DAPSONE

Application Number

214722

Product Number

1

Dosage Form

-

Strength

7.5%

Approval Date

2022-02-10

Regulatory Status

RX

2016
17 Nov
RX Application: 205209

Drug Name

DARIFENACIN HYDROBROMIDE

Product Number

1

Dosage Form

-

Strength

EQ 7.5MG BASE

Approval Date

2016-11-17

205209 / 1

Active Ingredient

DARIFENACIN HYDROBROMIDE

Application Number

205209

Product Number

1

Dosage Form

-

Strength

EQ 7.5MG BASE

Approval Date

2016-11-17

Regulatory Status

RX

2016
17 Nov
RX Application: 205209

Drug Name

DARIFENACIN HYDROBROMIDE

Product Number

2

Dosage Form

-

Strength

EQ 15MG BASE

Approval Date

2016-11-17

205209 / 2

Active Ingredient

DARIFENACIN HYDROBROMIDE

Application Number

205209

Product Number

2

Dosage Form

-

Strength

EQ 15MG BASE

Approval Date

2016-11-17

Regulatory Status

RX

2025
22 Jan
RX Application: 215891

Drug Name

DICLOFENAC POTASSIUM

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2025-01-22

215891 / 1

Active Ingredient

DICLOFENAC POTASSIUM

Application Number

215891

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2025-01-22

Regulatory Status

RX

2011
31 May
RX Application: 90686

Drug Name

DONEPEZIL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2011-05-31

90686 / 1

Active Ingredient

DONEPEZIL HYDROCHLORIDE

Application Number

90686

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2011-05-31

Regulatory Status

RX

2011
31 May
RX Application: 90686

Drug Name

DONEPEZIL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2011-05-31

90686 / 2

Active Ingredient

DONEPEZIL HYDROCHLORIDE

Application Number

90686

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2011-05-31

Regulatory Status

RX

2012
11 Sep
RX Application: 90939

Drug Name

ESCITALOPRAM OXALATE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2012-09-11

90939 / 1

Active Ingredient

ESCITALOPRAM OXALATE

Application Number

90939

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2012-09-11

Regulatory Status

RX

2012
11 Sep
RX Application: 90939

Drug Name

ESCITALOPRAM OXALATE

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2012-09-11

90939 / 2

Active Ingredient

ESCITALOPRAM OXALATE

Application Number

90939

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2012-09-11

Regulatory Status

RX

2012
11 Sep
RX Application: 90939

Drug Name

ESCITALOPRAM OXALATE

Product Number

3

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2012-09-11

90939 / 3

Active Ingredient

ESCITALOPRAM OXALATE

Application Number

90939

Product Number

3

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2012-09-11

Regulatory Status

RX

2024
27 Feb
RX Application: 211227

Drug Name

ESLICARBAZEPINE ACETATE

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2024-02-27

211227 / 1

Active Ingredient

ESLICARBAZEPINE ACETATE

Application Number

211227

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2024-02-27

Regulatory Status

RX

2024
27 Feb
RX Application: 211227

Drug Name

ESLICARBAZEPINE ACETATE

Product Number

2

Dosage Form

-

Strength

400MG

Approval Date

2024-02-27

211227 / 2

Active Ingredient

ESLICARBAZEPINE ACETATE

Application Number

211227

Product Number

2

Dosage Form

-

Strength

400MG

Approval Date

2024-02-27

Regulatory Status

RX

2024
27 Feb
RX Application: 211227

Drug Name

ESLICARBAZEPINE ACETATE

Product Number

3

Dosage Form

-

Strength

600MG

Approval Date

2024-02-27

211227 / 3

Active Ingredient

ESLICARBAZEPINE ACETATE

Application Number

211227

Product Number

3

Dosage Form

-

Strength

600MG

Approval Date

2024-02-27

Regulatory Status

RX

2024
27 Feb
RX Application: 211227

Drug Name

ESLICARBAZEPINE ACETATE

Product Number

4

Dosage Form

-

Strength

800MG

Approval Date

2024-02-27

211227 / 4

Active Ingredient

ESLICARBAZEPINE ACETATE

Application Number

211227

Product Number

4

Dosage Form

-

Strength

800MG

Approval Date

2024-02-27

Regulatory Status

RX

2025
05 Mar
RX Application: 212651

Drug Name

ESOMEPRAZOLE MAGNESIUM

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE/PACKET

Approval Date

2025-03-05

212651 / 1

Active Ingredient

ESOMEPRAZOLE MAGNESIUM

Application Number

212651

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE/PACKET

Approval Date

2025-03-05

Regulatory Status

RX

2025
05 Mar
RX Application: 212651

Drug Name

ESOMEPRAZOLE MAGNESIUM

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE/PACKET

Approval Date

2025-03-05

212651 / 2

Active Ingredient

ESOMEPRAZOLE MAGNESIUM

Application Number

212651

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE/PACKET

Approval Date

2025-03-05

Regulatory Status

RX

2025
05 Mar
RX Application: 212651

Drug Name

ESOMEPRAZOLE MAGNESIUM

Product Number

3

Dosage Form

-

Strength

EQ 20MG BASE/PACKET

Approval Date

2025-03-05

212651 / 3

Active Ingredient

ESOMEPRAZOLE MAGNESIUM

Application Number

212651

Product Number

3

Dosage Form

-

Strength

EQ 20MG BASE/PACKET

Approval Date

2025-03-05

Regulatory Status

RX

2025
05 Mar
RX Application: 212651

Drug Name

ESOMEPRAZOLE MAGNESIUM

Product Number

4

Dosage Form

-

Strength

EQ 40MG BASE/PACKET

Approval Date

2025-03-05

212651 / 4

Active Ingredient

ESOMEPRAZOLE MAGNESIUM

Application Number

212651

Product Number

4

Dosage Form

-

Strength

EQ 40MG BASE/PACKET

Approval Date

2025-03-05

Regulatory Status

RX

2025
05 Mar
RX Application: 212652

Drug Name

ESOMEPRAZOLE MAGNESIUM

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/PACKET

Approval Date

2025-03-05

212652 / 1

Active Ingredient

ESOMEPRAZOLE MAGNESIUM

Application Number

212652

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/PACKET

Approval Date

2025-03-05

Regulatory Status

RX

2011
28 Nov
RX Application: 202170

Drug Name

FELODIPINE

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2011-11-28

202170 / 1

Active Ingredient

FELODIPINE

Application Number

202170

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2011-11-28

Regulatory Status

RX

2011
28 Nov
RX Application: 202170

Drug Name

FELODIPINE

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2011-11-28

202170 / 2

Active Ingredient

FELODIPINE

Application Number

202170

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2011-11-28

Regulatory Status

RX

2011
28 Nov
RX Application: 202170

Drug Name

FELODIPINE

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2011-11-28

202170 / 3

Active Ingredient

FELODIPINE

Application Number

202170

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2011-11-28

Regulatory Status

RX

2018
26 Jun
RX Application: 210782

Drug Name

FENOFIBRATE (MICRONIZED)

Product Number

1

Dosage Form

-

Strength

67MG

Approval Date

2018-06-26

210782 / 1

Active Ingredient

FENOFIBRATE

Application Number

210782

Product Number

1

Dosage Form

-

Strength

67MG

Approval Date

2018-06-26

Regulatory Status

RX

2018
26 Jun
RX Application: 210782

Drug Name

FENOFIBRATE (MICRONIZED)

Product Number

2

Dosage Form

-

Strength

134MG

Approval Date

2018-06-26

210782 / 2

Active Ingredient

FENOFIBRATE

Application Number

210782

Product Number

2

Dosage Form

-

Strength

134MG

Approval Date

2018-06-26

Regulatory Status

RX

2018
26 Jun
RX Application: 210782

Drug Name

FENOFIBRATE (MICRONIZED)

Product Number

3

Dosage Form

-

Strength

200MG

Approval Date

2018-06-26

210782 / 3

Active Ingredient

FENOFIBRATE

Application Number

210782

Product Number

3

Dosage Form

-

Strength

200MG

Approval Date

2018-06-26

Regulatory Status

RX

2026
27 Jan
RX Application: 220374

Drug Name

FIDAXOMICIN

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2026-01-27

220374 / 1

Active Ingredient

FIDAXOMICIN

Application Number

220374

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2026-01-27

Regulatory Status

RX

2016
21 Oct
RX Application: 206937

Drug Name

FLUOXETINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2016-10-21

206937 / 1

Active Ingredient

FLUOXETINE HYDROCHLORIDE

Application Number

206937

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2016-10-21

Regulatory Status

RX

2016
21 Oct
RX Application: 206937

Drug Name

FLUOXETINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2016-10-21

206937 / 2

Active Ingredient

FLUOXETINE HYDROCHLORIDE

Application Number

206937

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2016-10-21

Regulatory Status

RX

2011
03 Jun
RX Application: 200270

Drug Name

ISOSORBIDE MONONITRATE

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

2011-06-03

200270 / 1

Active Ingredient

ISOSORBIDE MONONITRATE

Application Number

200270

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

2011-06-03

Regulatory Status

RX

2011
03 Jun
RX Application: 200495

Drug Name

ISOSORBIDE MONONITRATE

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

2011-06-03

200495 / 1

Active Ingredient

ISOSORBIDE MONONITRATE

Application Number

200495

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

2011-06-03

Regulatory Status

RX

2011
03 Jun
RX Application: 200495

Drug Name

ISOSORBIDE MONONITRATE

Product Number

2

Dosage Form

-

Strength

120MG

Approval Date

2011-06-03

200495 / 2

Active Ingredient

ISOSORBIDE MONONITRATE

Application Number

200495

Product Number

2

Dosage Form

-

Strength

120MG

Approval Date

2011-06-03

Regulatory Status

RX

2018
24 Aug
RX Application: 209460

Drug Name

ITRACONAZOLE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2018-08-24

209460 / 1

Active Ingredient

ITRACONAZOLE

Application Number

209460

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2018-08-24

Regulatory Status

RX

2009
27 Jan
RX Application: 78947

Drug Name

LAMOTRIGINE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2009-01-27

78947 / 1

Active Ingredient

LAMOTRIGINE

Application Number

78947

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2009-01-27

Regulatory Status

RX

2009
27 Jan
RX Application: 78947

Drug Name

LAMOTRIGINE

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2009-01-27

78947 / 2

Active Ingredient

LAMOTRIGINE

Application Number

78947

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2009-01-27

Regulatory Status

RX

2009
27 Jan
RX Application: 78947

Drug Name

LAMOTRIGINE

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2009-01-27

78947 / 3

Active Ingredient

LAMOTRIGINE

Application Number

78947

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2009-01-27

Regulatory Status

RX

2009
27 Jan
RX Application: 78947

Drug Name

LAMOTRIGINE

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2009-01-27

78947 / 4

Active Ingredient

LAMOTRIGINE

Application Number

78947

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2009-01-27

Regulatory Status

RX

2013
23 Dec
RX Application: 203370

Drug Name

LAMOTRIGINE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2013-12-23

203370 / 1

Active Ingredient

LAMOTRIGINE

Application Number

203370

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2013-12-23

Regulatory Status

RX

2013
23 Dec
RX Application: 203370

Drug Name

LAMOTRIGINE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2013-12-23

203370 / 2

Active Ingredient

LAMOTRIGINE

Application Number

203370

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2013-12-23

Regulatory Status

RX

2013
23 Dec
RX Application: 203370

Drug Name

LAMOTRIGINE

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2013-12-23

203370 / 3

Active Ingredient

LAMOTRIGINE

Application Number

203370

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2013-12-23

Regulatory Status

RX

2026
08 Jan
RX Application: 217100

Drug Name

LAMOTRIGINE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2026-01-08

217100 / 1

Active Ingredient

LAMOTRIGINE

Application Number

217100

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2026-01-08

Regulatory Status

RX

2026
08 Jan
RX Application: 217100

Drug Name

LAMOTRIGINE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2026-01-08

217100 / 2

Active Ingredient

LAMOTRIGINE

Application Number

217100

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2026-01-08

Regulatory Status

RX

2026
08 Jan
RX Application: 217100

Drug Name

LAMOTRIGINE

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2026-01-08

217100 / 3

Active Ingredient

LAMOTRIGINE

Application Number

217100

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2026-01-08

Regulatory Status

RX

2026
08 Jan
RX Application: 217100

Drug Name

LAMOTRIGINE

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2026-01-08

217100 / 4

Active Ingredient

LAMOTRIGINE

Application Number

217100

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2026-01-08

Regulatory Status

RX

2009
15 Jan
RX Application: 78858

Drug Name

LEVETIRACETAM

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2009-01-15

78858 / 1

Active Ingredient

LEVETIRACETAM

Application Number

78858

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2009-01-15

Regulatory Status

RX

2009
15 Jan
RX Application: 78858

Drug Name

LEVETIRACETAM

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2009-01-15

78858 / 2

Active Ingredient

LEVETIRACETAM

Application Number

78858

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2009-01-15

Regulatory Status

RX

2009
15 Jan
RX Application: 78858

Drug Name

LEVETIRACETAM

Product Number

3

Dosage Form

-

Strength

750MG

Approval Date

2009-01-15

78858 / 3

Active Ingredient

LEVETIRACETAM

Application Number

78858

Product Number

3

Dosage Form

-

Strength

750MG

Approval Date

2009-01-15

Regulatory Status

RX

2009
15 Jan
RX Application: 78858

Drug Name

LEVETIRACETAM

Product Number

4

Dosage Form

-

Strength

1GM

Approval Date

2009-01-15

78858 / 4

Active Ingredient

LEVETIRACETAM

Application Number

78858

Product Number

4

Dosage Form

-

Strength

1GM

Approval Date

2009-01-15

Regulatory Status

RX

2012
29 May
RX Application: 91338

Drug Name

LEVETIRACETAM

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2012-05-29

91338 / 1

Active Ingredient

LEVETIRACETAM

Application Number

91338

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2012-05-29

Regulatory Status

RX

2012
29 May
RX Application: 91338

Drug Name

LEVETIRACETAM

Product Number

2

Dosage Form

-

Strength

750MG

Approval Date

2012-05-29

91338 / 2

Active Ingredient

LEVETIRACETAM

Application Number

91338

Product Number

2

Dosage Form

-

Strength

750MG

Approval Date

2012-05-29

Regulatory Status

RX

2019
03 Jan
RX Application: 208055

Drug Name

LURASIDONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2019-01-03

208055 / 1

Active Ingredient

LURASIDONE HYDROCHLORIDE

Application Number

208055

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2019-01-03

Regulatory Status

RX

2019
03 Jan
RX Application: 208055

Drug Name

LURASIDONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

2019-01-03

208055 / 2

Active Ingredient

LURASIDONE HYDROCHLORIDE

Application Number

208055

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

2019-01-03

Regulatory Status

RX

2019
03 Jan
RX Application: 208055

Drug Name

LURASIDONE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

80MG

Approval Date

2019-01-03

208055 / 3

Active Ingredient

LURASIDONE HYDROCHLORIDE

Application Number

208055

Product Number

3

Dosage Form

-

Strength

80MG

Approval Date

2019-01-03

Regulatory Status

RX

2019
03 Jan
RX Application: 208055

Drug Name

LURASIDONE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

120MG

Approval Date

2019-01-03

208055 / 4

Active Ingredient

LURASIDONE HYDROCHLORIDE

Application Number

208055

Product Number

4

Dosage Form

-

Strength

120MG

Approval Date

2019-01-03

Regulatory Status

RX

2025
13 Jan
RX Application: 208055

Drug Name

LURASIDONE HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

60MG

Approval Date

2025-01-13

208055 / 5

Active Ingredient

LURASIDONE HYDROCHLORIDE

Application Number

208055

Product Number

5

Dosage Form

-

Strength

60MG

Approval Date

2025-01-13

Regulatory Status

RX

2024
05 Aug
RX Application: 211107

Drug Name

MACITENTAN

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2024-08-05

211107 / 1

Active Ingredient

MACITENTAN

Application Number

211107

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2024-08-05

Regulatory Status

RX

2000
30 Nov
RX Application: 65062

Drug Name

MINOCYCLINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2000-11-30

65062 / 1

Active Ingredient

MINOCYCLINE HYDROCHLORIDE

Application Number

65062

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2000-11-30

Regulatory Status

RX

2000
30 Nov
RX Application: 65062

Drug Name

MINOCYCLINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2000-11-30

65062 / 2

Active Ingredient

MINOCYCLINE HYDROCHLORIDE

Application Number

65062

Product Number

2

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2000-11-30

Regulatory Status

RX

2000
30 Nov
RX Application: 65062

Drug Name

MINOCYCLINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2000-11-30

65062 / 3

Active Ingredient

MINOCYCLINE HYDROCHLORIDE

Application Number

65062

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2000-11-30

Regulatory Status

RX

2004
06 Jan
RX Application: 65156

Drug Name

MINOCYCLINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2004-01-06

65156 / 1

Active Ingredient

MINOCYCLINE HYDROCHLORIDE

Application Number

65156

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2004-01-06

Regulatory Status

RX

2004
06 Jan
RX Application: 65156

Drug Name

MINOCYCLINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2004-01-06

65156 / 2

Active Ingredient

MINOCYCLINE HYDROCHLORIDE

Application Number

65156

Product Number

2

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2004-01-06

Regulatory Status

RX

2004
06 Jan
RX Application: 65156

Drug Name

MINOCYCLINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2004-01-06

65156 / 3

Active Ingredient

MINOCYCLINE HYDROCHLORIDE

Application Number

65156

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2004-01-06

Regulatory Status

RX

2018
13 Jul
RX Application: 207899

Drug Name

MOMETASONE FUROATE

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

2018-07-13

207899 / 1

Active Ingredient

MOMETASONE FUROATE

Application Number

207899

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

2018-07-13

Regulatory Status

RX

2012
03 Aug
RX Application: 90984

Drug Name

MONTELUKAST SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2012-08-03

90984 / 1

Active Ingredient

MONTELUKAST SODIUM

Application Number

90984

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2012-08-03

Regulatory Status

RX

2012
03 Aug
RX Application: 90984

Drug Name

MONTELUKAST SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2012-08-03

90984 / 2

Active Ingredient

MONTELUKAST SODIUM

Application Number

90984

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2012-08-03

Regulatory Status

RX

2012
03 Aug
RX Application: 201515

Drug Name

MONTELUKAST SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2012-08-03

201515 / 1

Active Ingredient

MONTELUKAST SODIUM

Application Number

201515

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2012-08-03

Regulatory Status

RX

2018
31 Jul
RX Application: 210431

Drug Name

MONTELUKAST SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE/PACKET

Approval Date

2018-07-31

210431 / 1

Active Ingredient

MONTELUKAST SODIUM

Application Number

210431

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE/PACKET

Approval Date

2018-07-31

Regulatory Status

RX

2025
15 Dec
RX Application: 218532

Drug Name

NILOTINIB HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2025-12-15

218532 / 1

Active Ingredient

NILOTINIB HYDROCHLORIDE

Application Number

218532

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2025-12-15

Regulatory Status

RX

2025
15 Dec
RX Application: 218532

Drug Name

NILOTINIB HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2025-12-15

218532 / 2

Active Ingredient

NILOTINIB HYDROCHLORIDE

Application Number

218532

Product Number

2

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2025-12-15

Regulatory Status

RX

2019
28 Jan
RX Application: 211838

Drug Name

NYSTATIN

Product Number

1

Dosage Form

-

Strength

100,000 UNITS/GM

Approval Date

2019-01-28

211838 / 1

Active Ingredient

NYSTATIN

Application Number

211838

Product Number

1

Dosage Form

-

Strength

100,000 UNITS/GM

Approval Date

2019-01-28

Regulatory Status

RX

2019
24 Jul
RX Application: 212557

Drug Name

NYSTATIN

Product Number

1

Dosage Form

-

Strength

100,000 UNITS/GM

Approval Date

2019-07-24

212557 / 1

Active Ingredient

NYSTATIN

Application Number

212557

Product Number

1

Dosage Form

-

Strength

100,000 UNITS/GM

Approval Date

2019-07-24

Regulatory Status

RX

2011
25 Oct
RX Application: 91415

Drug Name

OLANZAPINE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2011-10-25

91415 / 1

Active Ingredient

OLANZAPINE

Application Number

91415

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2011-10-25

Regulatory Status

RX

2011
25 Oct
RX Application: 91415

Drug Name

OLANZAPINE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2011-10-25

91415 / 2

Active Ingredient

OLANZAPINE

Application Number

91415

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2011-10-25

Regulatory Status

RX

2011
25 Oct
RX Application: 91415

Drug Name

OLANZAPINE

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

2011-10-25

91415 / 3

Active Ingredient

OLANZAPINE

Application Number

91415

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

2011-10-25

Regulatory Status

RX

2011
25 Oct
RX Application: 91415

Drug Name

OLANZAPINE

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2011-10-25

91415 / 4

Active Ingredient

OLANZAPINE

Application Number

91415

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2011-10-25

Regulatory Status

RX

2012
23 Apr
RX Application: 91434

Drug Name

OLANZAPINE

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2012-04-23

91434 / 1

Active Ingredient

OLANZAPINE

Application Number

91434

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2012-04-23

Regulatory Status

RX

2012
23 Apr
RX Application: 91434

Drug Name

OLANZAPINE

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2012-04-23

91434 / 2

Active Ingredient

OLANZAPINE

Application Number

91434

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2012-04-23

Regulatory Status

RX

2012
23 Apr
RX Application: 91434

Drug Name

OLANZAPINE

Product Number

3

Dosage Form

-

Strength

7.5MG

Approval Date

2012-04-23

91434 / 3

Active Ingredient

OLANZAPINE

Application Number

91434

Product Number

3

Dosage Form

-

Strength

7.5MG

Approval Date

2012-04-23

Regulatory Status

RX

2012
23 Apr
RX Application: 91434

Drug Name

OLANZAPINE

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2012-04-23

91434 / 4

Active Ingredient

OLANZAPINE

Application Number

91434

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2012-04-23

Regulatory Status

RX

2012
23 Apr
RX Application: 91434

Drug Name

OLANZAPINE

Product Number

5

Dosage Form

-

Strength

15MG

Approval Date

2012-04-23

91434 / 5

Active Ingredient

OLANZAPINE

Application Number

91434

Product Number

5

Dosage Form

-

Strength

15MG

Approval Date

2012-04-23

Regulatory Status

RX

2012
23 Apr
RX Application: 91434

Drug Name

OLANZAPINE

Product Number

6

Dosage Form

-

Strength

20MG

Approval Date

2012-04-23

91434 / 6

Active Ingredient

OLANZAPINE

Application Number

91434

Product Number

6

Dosage Form

-

Strength

20MG

Approval Date

2012-04-23

Regulatory Status

RX

2016
26 Oct
RX Application: 203580

Drug Name

OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE;12.5MG;40MG

Approval Date

2016-10-26

203580 / 2

Active Ingredient

AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL

Application Number

203580

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE;12.5MG;40MG

Approval Date

2016-10-26

Regulatory Status

RX

2016
26 Oct
RX Application: 203580

Drug Name

OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE

Product Number

3

Dosage Form

-

Strength

EQ 5MG BASE;25MG;40MG

Approval Date

2016-10-26

203580 / 3

Active Ingredient

AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL

Application Number

203580

Product Number

3

Dosage Form

-

Strength

EQ 5MG BASE;25MG;40MG

Approval Date

2016-10-26

Regulatory Status

RX

2011
19 Jan
RX Application: 90074

Drug Name

PANTOPRAZOLE SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2011-01-19

90074 / 1

Active Ingredient

PANTOPRAZOLE SODIUM

Application Number

90074

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2011-01-19

Regulatory Status

RX

2011
19 Jan
RX Application: 90074

Drug Name

PANTOPRAZOLE SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2011-01-19

90074 / 2

Active Ingredient

PANTOPRAZOLE SODIUM

Application Number

90074

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2011-01-19

Regulatory Status

RX

2025
04 Sep
RX Application: 219922

Drug Name

PAZOPANIB HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 400MG BASE

Approval Date

2025-09-04

219922 / 1

Active Ingredient

PAZOPANIB HYDROCHLORIDE

Application Number

219922

Product Number

1

Dosage Form

-

Strength

EQ 400MG BASE

Approval Date

2025-09-04

Regulatory Status

RX

2023
07 Aug
RX Application: 216981

Drug Name

PENCICLOVIR

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

2023-08-07

216981 / 1

Active Ingredient

PENCICLOVIR

Application Number

216981

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

2023-08-07

Regulatory Status

RX

2013
13 Feb
RX Application: 202001

Drug Name

PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

500MG;EQ 15MG BASE

Approval Date

2013-02-13

202001 / 1

Active Ingredient

METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE

Application Number

202001

Product Number

1

Dosage Form

-

Strength

500MG;EQ 15MG BASE

Approval Date

2013-02-13

Regulatory Status

RX

2013
13 Feb
RX Application: 202001

Drug Name

PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

850MG;EQ 15MG BASE

Approval Date

2013-02-13

202001 / 2

Active Ingredient

METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE

Application Number

202001

Product Number

2

Dosage Form

-

Strength

850MG;EQ 15MG BASE

Approval Date

2013-02-13

Regulatory Status

RX

2010
08 Oct
RX Application: 90865

Drug Name

PRAMIPEXOLE DIHYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.125MG

Approval Date

2010-10-08

90865 / 1

Active Ingredient

PRAMIPEXOLE DIHYDROCHLORIDE

Application Number

90865

Product Number

1

Dosage Form

-

Strength

0.125MG

Approval Date

2010-10-08

Regulatory Status

RX

2010
08 Oct
RX Application: 90865

Drug Name

PRAMIPEXOLE DIHYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

0.25MG

Approval Date

2010-10-08

90865 / 2

Active Ingredient

PRAMIPEXOLE DIHYDROCHLORIDE

Application Number

90865

Product Number

2

Dosage Form

-

Strength

0.25MG

Approval Date

2010-10-08

Regulatory Status

RX

2010
08 Oct
RX Application: 90865

Drug Name

PRAMIPEXOLE DIHYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

0.5MG

Approval Date

2010-10-08

90865 / 3

Active Ingredient

PRAMIPEXOLE DIHYDROCHLORIDE

Application Number

90865

Product Number

3

Dosage Form

-

Strength

0.5MG

Approval Date

2010-10-08

Regulatory Status

RX

2010
08 Oct
RX Application: 90865

Drug Name

PRAMIPEXOLE DIHYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

0.75MG

Approval Date

2010-10-08

90865 / 4

Active Ingredient

PRAMIPEXOLE DIHYDROCHLORIDE

Application Number

90865

Product Number

4

Dosage Form

-

Strength

0.75MG

Approval Date

2010-10-08

Regulatory Status

RX

2010
08 Oct
RX Application: 90865

Drug Name

PRAMIPEXOLE DIHYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

1MG

Approval Date

2010-10-08

90865 / 5

Active Ingredient

PRAMIPEXOLE DIHYDROCHLORIDE

Application Number

90865

Product Number

5

Dosage Form

-

Strength

1MG

Approval Date

2010-10-08

Regulatory Status

RX

2010
08 Oct
RX Application: 90865

Drug Name

PRAMIPEXOLE DIHYDROCHLORIDE

Product Number

6

Dosage Form

-

Strength

1.5MG

Approval Date

2010-10-08

90865 / 6

Active Ingredient

PRAMIPEXOLE DIHYDROCHLORIDE

Application Number

90865

Product Number

6

Dosage Form

-

Strength

1.5MG

Approval Date

2010-10-08

Regulatory Status

RX

2025
21 Feb
RX Application: 206942

Drug Name

PREGABALIN

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2025-02-21

206942 / 1

Active Ingredient

PREGABALIN

Application Number

206942

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2025-02-21

Regulatory Status

RX

2025
21 Feb
RX Application: 206942

Drug Name

PREGABALIN

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2025-02-21

206942 / 2

Active Ingredient

PREGABALIN

Application Number

206942

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2025-02-21

Regulatory Status

RX

2025
21 Feb
RX Application: 206942

Drug Name

PREGABALIN

Product Number

3

Dosage Form

-

Strength

75MG

Approval Date

2025-02-21

206942 / 3

Active Ingredient

PREGABALIN

Application Number

206942

Product Number

3

Dosage Form

-

Strength

75MG

Approval Date

2025-02-21

Regulatory Status

RX

2025
21 Feb
RX Application: 206942

Drug Name

PREGABALIN

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

2025-02-21

206942 / 4

Active Ingredient

PREGABALIN

Application Number

206942

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

2025-02-21

Regulatory Status

RX

2025
21 Feb
RX Application: 206942

Drug Name

PREGABALIN

Product Number

5

Dosage Form

-

Strength

150MG

Approval Date

2025-02-21

206942 / 5

Active Ingredient

PREGABALIN

Application Number

206942

Product Number

5

Dosage Form

-

Strength

150MG

Approval Date

2025-02-21

Regulatory Status

RX

2025
21 Feb
RX Application: 206942

Drug Name

PREGABALIN

Product Number

6

Dosage Form

-

Strength

200MG

Approval Date

2025-02-21

206942 / 6

Active Ingredient

PREGABALIN

Application Number

206942

Product Number

6

Dosage Form

-

Strength

200MG

Approval Date

2025-02-21

Regulatory Status

RX

2025
21 Feb
RX Application: 206942

Drug Name

PREGABALIN

Product Number

7

Dosage Form

-

Strength

225MG

Approval Date

2025-02-21

206942 / 7

Active Ingredient

PREGABALIN

Application Number

206942

Product Number

7

Dosage Form

-

Strength

225MG

Approval Date

2025-02-21

Regulatory Status

RX

2025
21 Feb
RX Application: 206942

Drug Name

PREGABALIN

Product Number

8

Dosage Form

-

Strength

300MG

Approval Date

2025-02-21

206942 / 8

Active Ingredient

PREGABALIN

Application Number

206942

Product Number

8

Dosage Form

-

Strength

300MG

Approval Date

2025-02-21

Regulatory Status

RX

2013
08 Nov
RX Application: 202376

Drug Name

RABEPRAZOLE SODIUM

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2013-11-08

202376 / 1

Active Ingredient

RABEPRAZOLE SODIUM

Application Number

202376

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2013-11-08

Regulatory Status

RX

2025
05 May
RX Application: 210150

Drug Name

RASAGILINE MESYLATE

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE

Approval Date

2025-05-05

210150 / 1

Active Ingredient

RASAGILINE MESYLATE

Application Number

210150

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE

Approval Date

2025-05-05

Regulatory Status

RX

2025
05 May
RX Application: 210150

Drug Name

RASAGILINE MESYLATE

Product Number

2

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2025-05-05

210150 / 2

Active Ingredient

RASAGILINE MESYLATE

Application Number

210150

Product Number

2

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2025-05-05

Regulatory Status

RX

2008
30 Oct
RX Application: 79088

Drug Name

RISPERIDONE

Product Number

1

Dosage Form

-

Strength

0.25MG

Approval Date

2008-10-30

79088 / 1

Active Ingredient

RISPERIDONE

Application Number

79088

Product Number

1

Dosage Form

-

Strength

0.25MG

Approval Date

2008-10-30

Regulatory Status

RX

2008
30 Oct
RX Application: 79088

Drug Name

RISPERIDONE

Product Number

2

Dosage Form

-

Strength

0.5MG

Approval Date

2008-10-30

79088 / 2

Active Ingredient

RISPERIDONE

Application Number

79088

Product Number

2

Dosage Form

-

Strength

0.5MG

Approval Date

2008-10-30

Regulatory Status

RX

2008
30 Oct
RX Application: 79088

Drug Name

RISPERIDONE

Product Number

3

Dosage Form

-

Strength

1MG

Approval Date

2008-10-30

79088 / 3

Active Ingredient

RISPERIDONE

Application Number

79088

Product Number

3

Dosage Form

-

Strength

1MG

Approval Date

2008-10-30

Regulatory Status

RX

2008
30 Oct
RX Application: 79088

Drug Name

RISPERIDONE

Product Number

4

Dosage Form

-

Strength

2MG

Approval Date

2008-10-30

79088 / 4

Active Ingredient

RISPERIDONE

Application Number

79088

Product Number

4

Dosage Form

-

Strength

2MG

Approval Date

2008-10-30

Regulatory Status

RX

2008
30 Oct
RX Application: 79088

Drug Name

RISPERIDONE

Product Number

5

Dosage Form

-

Strength

3MG

Approval Date

2008-10-30

79088 / 5

Active Ingredient

RISPERIDONE

Application Number

79088

Product Number

5

Dosage Form

-

Strength

3MG

Approval Date

2008-10-30

Regulatory Status

RX

2008
30 Oct
RX Application: 79088

Drug Name

RISPERIDONE

Product Number

6

Dosage Form

-

Strength

4MG

Approval Date

2008-10-30

79088 / 6

Active Ingredient

RISPERIDONE

Application Number

79088

Product Number

6

Dosage Form

-

Strength

4MG

Approval Date

2008-10-30

Regulatory Status

RX

2016
31 Oct
RX Application: 201619

Drug Name

ROSUVASTATIN CALCIUM

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2016-10-31

201619 / 1

Active Ingredient

ROSUVASTATIN CALCIUM

Application Number

201619

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2016-10-31

Regulatory Status

RX

2016
31 Oct
RX Application: 201619

Drug Name

ROSUVASTATIN CALCIUM

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2016-10-31

201619 / 2

Active Ingredient

ROSUVASTATIN CALCIUM

Application Number

201619

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2016-10-31

Regulatory Status

RX

2016
31 Oct
RX Application: 201619

Drug Name

ROSUVASTATIN CALCIUM

Product Number

3

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2016-10-31

201619 / 3

Active Ingredient

ROSUVASTATIN CALCIUM

Application Number

201619

Product Number

3

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2016-10-31

Regulatory Status

RX

2016
31 Oct
RX Application: 201619

Drug Name

ROSUVASTATIN CALCIUM

Product Number

4

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2016-10-31

201619 / 4

Active Ingredient

ROSUVASTATIN CALCIUM

Application Number

201619

Product Number

4

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2016-10-31

Regulatory Status

RX

2024
22 Aug
RX Application: 213604

Drug Name

SACUBITRIL AND VALSARTAN

Product Number

1

Dosage Form

-

Strength

24MG;26MG

Approval Date

2024-08-22

213604 / 1

Active Ingredient

SACUBITRIL; VALSARTAN

Application Number

213604

Product Number

1

Dosage Form

-

Strength

24MG;26MG

Approval Date

2024-08-22

Regulatory Status

RX

2024
22 Aug
RX Application: 213604

Drug Name

SACUBITRIL AND VALSARTAN

Product Number

2

Dosage Form

-

Strength

49MG;51MG

Approval Date

2024-08-22

213604 / 2

Active Ingredient

SACUBITRIL; VALSARTAN

Application Number

213604

Product Number

2

Dosage Form

-

Strength

49MG;51MG

Approval Date

2024-08-22

Regulatory Status

RX

2024
22 Aug
RX Application: 213604

Drug Name

SACUBITRIL AND VALSARTAN

Product Number

3

Dosage Form

-

Strength

97MG;103MG

Approval Date

2024-08-22

213604 / 3

Active Ingredient

SACUBITRIL; VALSARTAN

Application Number

213604

Product Number

3

Dosage Form

-

Strength

97MG;103MG

Approval Date

2024-08-22

Regulatory Status

RX

2018
11 Jun
RX Application: 91448

Drug Name

SILDENAFIL CITRATE

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2018-06-11

91448 / 1

Active Ingredient

SILDENAFIL CITRATE

Application Number

91448

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2018-06-11

Regulatory Status

RX

2018
11 Jun
RX Application: 91448

Drug Name

SILDENAFIL CITRATE

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2018-06-11

91448 / 2

Active Ingredient

SILDENAFIL CITRATE

Application Number

91448

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2018-06-11

Regulatory Status

RX

2018
11 Jun
RX Application: 91448

Drug Name

SILDENAFIL CITRATE

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2018-06-11

91448 / 3

Active Ingredient

SILDENAFIL CITRATE

Application Number

91448

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2018-06-11

Regulatory Status

RX

2012
06 Nov
RX Application: 91479

Drug Name

SILDENAFIL CITRATE

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2012-11-06

91479 / 1

Active Ingredient

SILDENAFIL CITRATE

Application Number

91479

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2012-11-06

Regulatory Status

RX

2023
12 Apr
RX Application: 217095

Drug Name

SORAFENIB TOSYLATE

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2023-04-12

217095 / 1

Active Ingredient

SORAFENIB TOSYLATE

Application Number

217095

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2023-04-12

Regulatory Status

RX

2019
26 Mar
RX Application: 211839

Drug Name

TADALAFIL

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2019-03-26

211839 / 1

Active Ingredient

TADALAFIL

Application Number

211839

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2019-03-26

Regulatory Status

RX

2019
26 Mar
RX Application: 211839

Drug Name

TADALAFIL

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2019-03-26

211839 / 2

Active Ingredient

TADALAFIL

Application Number

211839

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2019-03-26

Regulatory Status

RX

2019
26 Mar
RX Application: 211839

Drug Name

TADALAFIL

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2019-03-26

211839 / 3

Active Ingredient

TADALAFIL

Application Number

211839

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2019-03-26

Regulatory Status

RX

2019
26 Mar
RX Application: 211839

Drug Name

TADALAFIL

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2019-03-26

211839 / 4

Active Ingredient

TADALAFIL

Application Number

211839

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2019-03-26

Regulatory Status

RX

2019
26 Mar
RX Application: 212062

Drug Name

TADALAFIL

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2019-03-26

212062 / 1

Active Ingredient

TADALAFIL

Application Number

212062

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2019-03-26

Regulatory Status

RX

2026
20 May
RX Application: 212062

Drug Name

TADALAFIL

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

2026-05-20

212062 / 2

Active Ingredient

TADALAFIL

Application Number

212062

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

2026-05-20

Regulatory Status

RX

2014
07 Jul
RX Application: 203171

Drug Name

TELMISARTAN

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2014-07-07

203171 / 1

Active Ingredient

TELMISARTAN

Application Number

203171

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2014-07-07

Regulatory Status

RX

2014
07 Jul
RX Application: 203171

Drug Name

TELMISARTAN

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

2014-07-07

203171 / 2

Active Ingredient

TELMISARTAN

Application Number

203171

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

2014-07-07

Regulatory Status

RX

2014
07 Jul
RX Application: 203171

Drug Name

TELMISARTAN

Product Number

3

Dosage Form

-

Strength

80MG

Approval Date

2014-07-07

203171 / 3

Active Ingredient

TELMISARTAN

Application Number

203171

Product Number

3

Dosage Form

-

Strength

80MG

Approval Date

2014-07-07

Regulatory Status

RX

2015
11 Aug
RX Application: 203016

Drug Name

TOLTERODINE TARTRATE

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2015-08-11

203016 / 1

Active Ingredient

TOLTERODINE TARTRATE

Application Number

203016

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2015-08-11

Regulatory Status

RX

2015
11 Aug
RX Application: 203016

Drug Name

TOLTERODINE TARTRATE

Product Number

2

Dosage Form

-

Strength

4MG

Approval Date

2015-08-11

203016 / 2

Active Ingredient

TOLTERODINE TARTRATE

Application Number

203016

Product Number

2

Dosage Form

-

Strength

4MG

Approval Date

2015-08-11

Regulatory Status

RX

2013
27 Nov
RX Application: 202180

Drug Name

TRAZODONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2013-11-27

202180 / 1

Active Ingredient

TRAZODONE HYDROCHLORIDE

Application Number

202180

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2013-11-27

Regulatory Status

RX

2013
27 Nov
RX Application: 202180

Drug Name

TRAZODONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2013-11-27

202180 / 2

Active Ingredient

TRAZODONE HYDROCHLORIDE

Application Number

202180

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2013-11-27

Regulatory Status

RX

2013
27 Nov
RX Application: 202180

Drug Name

TRAZODONE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2013-11-27

202180 / 3

Active Ingredient

TRAZODONE HYDROCHLORIDE

Application Number

202180

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2013-11-27

Regulatory Status

RX

2013
27 Nov
RX Application: 202180

Drug Name

TRAZODONE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

300MG

Approval Date

2013-11-27

202180 / 4

Active Ingredient

TRAZODONE HYDROCHLORIDE

Application Number

202180

Product Number

4

Dosage Form

-

Strength

300MG

Approval Date

2013-11-27

Regulatory Status

RX

2024
30 Jan
RX Application: 216990

Drug Name

VENXXIVA

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2024-01-30

216990 / 1

Active Ingredient

TIOPRONIN

Application Number

216990

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2024-01-30

Regulatory Status

RX

2024
30 Jan
RX Application: 216990

Drug Name

VENXXIVA

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2024-01-30

216990 / 2

Active Ingredient

TIOPRONIN

Application Number

216990

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2024-01-30

Regulatory Status

RX

2007
17 Aug
RX Application: 77903

Drug Name

ZOLPIDEM TARTRATE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2007-08-17

77903 / 1

Active Ingredient

ZOLPIDEM TARTRATE

Application Number

77903

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2007-08-17

Regulatory Status

RX

2007
17 Aug
RX Application: 77903

Drug Name

ZOLPIDEM TARTRATE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2007-08-17

77903 / 2

Active Ingredient

ZOLPIDEM TARTRATE

Application Number

77903

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2007-08-17

Regulatory Status

RX

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Drug Status Breakdown
165 total
  • RX
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

209971

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

Structured Database

Searchable pharmaceutical data

Reliable Data

Organized FDA drug records

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