Ajanta Pharma Limited RX
FDA Approved Drugs

Ajanta Pharma 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 137
  • Latest Approval Date Apr 07, 2026
  • Data Source FDA
  • First Approval Date Aug 24, 2011
All
191
View
Unclassified
12
View
Discontinued
42
View
RX
137
View
Company Overview

Company

Ajanta Pharma Limited RX

Country

India

Website

Visit Website

Email

info@ajantapharma.com

Social Profiles

Company Snapshot

Ajanta Pharma Limited RX

98, Ajanta House, Charkop, Kandivili (West) Mumbai, 400 067, India

India

www.ajantapharma.com/ info@ajantapharma.com View on Map
FDA Approved Drug Records ( 137 records )
2016
03 Mar
RX Application: 205523

Drug Name

ALMOTRIPTAN MALATE

Product Number

1

Dosage Form

-

Strength

EQ 6.25MG BASE

Approval Date

2016-03-03

205523 / 1

Active Ingredient

ALMOTRIPTAN MALATE

Application Number

205523

Product Number

1

Dosage Form

-

Strength

EQ 6.25MG BASE

Approval Date

2016-03-03

Regulatory Status

RX

2016
03 Mar
RX Application: 205523

Drug Name

ALMOTRIPTAN MALATE

Product Number

2

Dosage Form

-

Strength

EQ 12.5MG BASE

Approval Date

2016-03-03

205523 / 2

Active Ingredient

ALMOTRIPTAN MALATE

Application Number

205523

Product Number

2

Dosage Form

-

Strength

EQ 12.5MG BASE

Approval Date

2016-03-03

Regulatory Status

RX

2016
28 Oct
RX Application: 207216

Drug Name

AMLODIPINE AND OLMESARTAN MEDOXOMIL

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE;20MG

Approval Date

2016-10-28

207216 / 1

Active Ingredient

AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL

Application Number

207216

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE;20MG

Approval Date

2016-10-28

Regulatory Status

RX

2016
28 Oct
RX Application: 207216

Drug Name

AMLODIPINE AND OLMESARTAN MEDOXOMIL

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE;40MG

Approval Date

2016-10-28

207216 / 2

Active Ingredient

AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL

Application Number

207216

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE;40MG

Approval Date

2016-10-28

Regulatory Status

RX

2016
28 Oct
RX Application: 207216

Drug Name

AMLODIPINE AND OLMESARTAN MEDOXOMIL

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE;20MG

Approval Date

2016-10-28

207216 / 3

Active Ingredient

AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL

Application Number

207216

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE;20MG

Approval Date

2016-10-28

Regulatory Status

RX

2016
28 Oct
RX Application: 207216

Drug Name

AMLODIPINE AND OLMESARTAN MEDOXOMIL

Product Number

4

Dosage Form

-

Strength

EQ 10MG BASE;40MG

Approval Date

2016-10-28

207216 / 4

Active Ingredient

AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL

Application Number

207216

Product Number

4

Dosage Form

-

Strength

EQ 10MG BASE;40MG

Approval Date

2016-10-28

Regulatory Status

RX

2016
12 Sep
RX Application: 206174

Drug Name

ARIPIPRAZOLE

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2016-09-12

206174 / 1

Active Ingredient

ARIPIPRAZOLE

Application Number

206174

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2016-09-12

Regulatory Status

RX

2016
12 Sep
RX Application: 206174

Drug Name

ARIPIPRAZOLE

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2016-09-12

206174 / 2

Active Ingredient

ARIPIPRAZOLE

Application Number

206174

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2016-09-12

Regulatory Status

RX

2016
12 Sep
RX Application: 206174

Drug Name

ARIPIPRAZOLE

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2016-09-12

206174 / 3

Active Ingredient

ARIPIPRAZOLE

Application Number

206174

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2016-09-12

Regulatory Status

RX

2016
12 Sep
RX Application: 206174

Drug Name

ARIPIPRAZOLE

Product Number

4

Dosage Form

-

Strength

15MG

Approval Date

2016-09-12

206174 / 4

Active Ingredient

ARIPIPRAZOLE

Application Number

206174

Product Number

4

Dosage Form

-

Strength

15MG

Approval Date

2016-09-12

Regulatory Status

RX

2016
12 Sep
RX Application: 206174

Drug Name

ARIPIPRAZOLE

Product Number

5

Dosage Form

-

Strength

20MG

Approval Date

2016-09-12

206174 / 5

Active Ingredient

ARIPIPRAZOLE

Application Number

206174

Product Number

5

Dosage Form

-

Strength

20MG

Approval Date

2016-09-12

Regulatory Status

RX

2016
12 Sep
RX Application: 206174

Drug Name

ARIPIPRAZOLE

Product Number

6

Dosage Form

-

Strength

30MG

Approval Date

2016-09-12

206174 / 6

Active Ingredient

ARIPIPRAZOLE

Application Number

206174

Product Number

6

Dosage Form

-

Strength

30MG

Approval Date

2016-09-12

Regulatory Status

RX

2019
13 Dec
RX Application: 212809

Drug Name

CAPTOPRIL

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

2019-12-13

212809 / 1

Active Ingredient

CAPTOPRIL

Application Number

212809

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

2019-12-13

Regulatory Status

RX

2019
13 Dec
RX Application: 212809

Drug Name

CAPTOPRIL

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2019-12-13

212809 / 2

Active Ingredient

CAPTOPRIL

Application Number

212809

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2019-12-13

Regulatory Status

RX

2019
13 Dec
RX Application: 212809

Drug Name

CAPTOPRIL

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

2019-12-13

212809 / 3

Active Ingredient

CAPTOPRIL

Application Number

212809

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

2019-12-13

Regulatory Status

RX

2019
13 Dec
RX Application: 212809

Drug Name

CAPTOPRIL

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

2019-12-13

212809 / 4

Active Ingredient

CAPTOPRIL

Application Number

212809

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

2019-12-13

Regulatory Status

RX

2020
27 Nov
RX Application: 214129

Drug Name

CHLORTHALIDONE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2020-11-27

214129 / 1

Active Ingredient

CHLORTHALIDONE

Application Number

214129

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2020-11-27

Regulatory Status

RX

2020
27 Nov
RX Application: 214129

Drug Name

CHLORTHALIDONE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2020-11-27

214129 / 2

Active Ingredient

CHLORTHALIDONE

Application Number

214129

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2020-11-27

Regulatory Status

RX

2020
06 Apr
RX Application: 211119

Drug Name

CHOLESTYRAMINE

Product Number

1

Dosage Form

-

Strength

EQ 4GM RESIN/PACKET

Approval Date

2020-04-06

211119 / 1

Active Ingredient

CHOLESTYRAMINE

Application Number

211119

Product Number

1

Dosage Form

-

Strength

EQ 4GM RESIN/PACKET

Approval Date

2020-04-06

Regulatory Status

RX

2020
06 Apr
RX Application: 211119

Drug Name

CHOLESTYRAMINE

Product Number

2

Dosage Form

-

Strength

EQ 4GM RESIN/SCOOPFUL

Approval Date

2020-04-06

211119 / 2

Active Ingredient

CHOLESTYRAMINE

Application Number

211119

Product Number

2

Dosage Form

-

Strength

EQ 4GM RESIN/SCOOPFUL

Approval Date

2020-04-06

Regulatory Status

RX

2017
20 Nov
RX Application: 209686

Drug Name

CLONIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.1MG

Approval Date

2017-11-20

209686 / 1

Active Ingredient

CLONIDINE HYDROCHLORIDE

Application Number

209686

Product Number

1

Dosage Form

-

Strength

0.1MG

Approval Date

2017-11-20

Regulatory Status

RX

2026
06 Apr
RX Application: 211482

Drug Name

DAPAGLIFLOZIN

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2026-04-06

211482 / 1

Active Ingredient

DAPAGLIFLOZIN

Application Number

211482

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2026-04-06

Regulatory Status

RX

2026
06 Apr
RX Application: 211482

Drug Name

DAPAGLIFLOZIN

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2026-04-06

211482 / 2

Active Ingredient

DAPAGLIFLOZIN

Application Number

211482

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2026-04-06

Regulatory Status

RX

2020
02 Mar
RX Application: 213181

Drug Name

DIVALPROEX SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 125MG VALPROIC ACID

Approval Date

2020-03-02

213181 / 1

Active Ingredient

DIVALPROEX SODIUM

Application Number

213181

Product Number

1

Dosage Form

-

Strength

EQ 125MG VALPROIC ACID

Approval Date

2020-03-02

Regulatory Status

RX

2019
13 Sep
RX Application: 212624

Drug Name

DOXEPIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2019-09-13

212624 / 1

Active Ingredient

DOXEPIN HYDROCHLORIDE

Application Number

212624

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2019-09-13

Regulatory Status

RX

2019
13 Sep
RX Application: 212624

Drug Name

DOXEPIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2019-09-13

212624 / 2

Active Ingredient

DOXEPIN HYDROCHLORIDE

Application Number

212624

Product Number

2

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2019-09-13

Regulatory Status

RX

2019
13 Sep
RX Application: 212624

Drug Name

DOXEPIN HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2019-09-13

212624 / 3

Active Ingredient

DOXEPIN HYDROCHLORIDE

Application Number

212624

Product Number

3

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2019-09-13

Regulatory Status

RX

2019
13 Sep
RX Application: 212624

Drug Name

DOXEPIN HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2019-09-13

212624 / 4

Active Ingredient

DOXEPIN HYDROCHLORIDE

Application Number

212624

Product Number

4

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2019-09-13

Regulatory Status

RX

2019
13 Sep
RX Application: 212624

Drug Name

DOXEPIN HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2019-09-13

212624 / 5

Active Ingredient

DOXEPIN HYDROCHLORIDE

Application Number

212624

Product Number

5

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2019-09-13

Regulatory Status

RX

2024
01 Jul
RX Application: 218564

Drug Name

DOXEPIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 3MG BASE

Approval Date

2024-07-01

218564 / 1

Active Ingredient

DOXEPIN HYDROCHLORIDE

Application Number

218564

Product Number

1

Dosage Form

-

Strength

EQ 3MG BASE

Approval Date

2024-07-01

Regulatory Status

RX

2024
01 Jul
RX Application: 218564

Drug Name

DOXEPIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 6MG BASE

Approval Date

2024-07-01

218564 / 2

Active Ingredient

DOXEPIN HYDROCHLORIDE

Application Number

218564

Product Number

2

Dosage Form

-

Strength

EQ 6MG BASE

Approval Date

2024-07-01

Regulatory Status

RX

2020
01 Jun
RX Application: 211584

Drug Name

DOXYCYCLINE HYCLATE

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2020-06-01

211584 / 1

Active Ingredient

DOXYCYCLINE HYCLATE

Application Number

211584

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2020-06-01

Regulatory Status

RX

2020
01 Jun
RX Application: 211584

Drug Name

DOXYCYCLINE HYCLATE

Product Number

2

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2020-06-01

211584 / 2

Active Ingredient

DOXYCYCLINE HYCLATE

Application Number

211584

Product Number

2

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2020-06-01

Regulatory Status

RX

2017
06 Jan
RX Application: 208706

Drug Name

DULOXETINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2017-01-06

208706 / 1

Active Ingredient

DULOXETINE HYDROCHLORIDE

Application Number

208706

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2017-01-06

Regulatory Status

RX

2017
06 Jan
RX Application: 208706

Drug Name

DULOXETINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

2017-01-06

208706 / 2

Active Ingredient

DULOXETINE HYDROCHLORIDE

Application Number

208706

Product Number

2

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

2017-01-06

Regulatory Status

RX

2017
06 Jan
RX Application: 208706

Drug Name

DULOXETINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 60MG BASE

Approval Date

2017-01-06

208706 / 3

Active Ingredient

DULOXETINE HYDROCHLORIDE

Application Number

208706

Product Number

3

Dosage Form

-

Strength

EQ 60MG BASE

Approval Date

2017-01-06

Regulatory Status

RX

2019
11 Mar
RX Application: 208706

Drug Name

DULOXETINE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2019-03-11

208706 / 4

Active Ingredient

DULOXETINE HYDROCHLORIDE

Application Number

208706

Product Number

4

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2019-03-11

Regulatory Status

RX

2017
31 Aug
RX Application: 205792

Drug Name

ENTACAPONE

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2017-08-31

205792 / 1

Active Ingredient

ENTACAPONE

Application Number

205792

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2017-08-31

Regulatory Status

RX

2023
18 Sep
RX Application: 217529

Drug Name

FAMOTIDINE

Product Number

1

Dosage Form

-

Strength

40MG/5ML

Approval Date

2023-09-18

217529 / 1

Active Ingredient

FAMOTIDINE

Application Number

217529

Product Number

1

Dosage Form

-

Strength

40MG/5ML

Approval Date

2023-09-18

Regulatory Status

RX

2018
23 Jul
RX Application: 210138

Drug Name

FENOFIBRATE

Product Number

1

Dosage Form

-

Strength

54MG

Approval Date

2018-07-23

210138 / 1

Active Ingredient

FENOFIBRATE

Application Number

210138

Product Number

1

Dosage Form

-

Strength

54MG

Approval Date

2018-07-23

Regulatory Status

RX

2018
23 Jul
RX Application: 210138

Drug Name

FENOFIBRATE

Product Number

2

Dosage Form

-

Strength

160MG

Approval Date

2018-07-23

210138 / 2

Active Ingredient

FENOFIBRATE

Application Number

210138

Product Number

2

Dosage Form

-

Strength

160MG

Approval Date

2018-07-23

Regulatory Status

RX

2018
10 Sep
RX Application: 210705

Drug Name

FENOFIBRATE (MICRONIZED)

Product Number

1

Dosage Form

-

Strength

67MG

Approval Date

2018-09-10

210705 / 1

Active Ingredient

FENOFIBRATE

Application Number

210705

Product Number

1

Dosage Form

-

Strength

67MG

Approval Date

2018-09-10

Regulatory Status

RX

2018
10 Sep
RX Application: 210705

Drug Name

FENOFIBRATE (MICRONIZED)

Product Number

2

Dosage Form

-

Strength

134MG

Approval Date

2018-09-10

210705 / 2

Active Ingredient

FENOFIBRATE

Application Number

210705

Product Number

2

Dosage Form

-

Strength

134MG

Approval Date

2018-09-10

Regulatory Status

RX

2018
10 Sep
RX Application: 210705

Drug Name

FENOFIBRATE (MICRONIZED)

Product Number

3

Dosage Form

-

Strength

200MG

Approval Date

2018-09-10

210705 / 3

Active Ingredient

FENOFIBRATE

Application Number

210705

Product Number

3

Dosage Form

-

Strength

200MG

Approval Date

2018-09-10

Regulatory Status

RX

2023
05 Jan
RX Application: 217410

Drug Name

FLUPHENAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2023-01-05

217410 / 1

Active Ingredient

FLUPHENAZINE HYDROCHLORIDE

Application Number

217410

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2023-01-05

Regulatory Status

RX

2023
05 Jan
RX Application: 217410

Drug Name

FLUPHENAZINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

2.5MG

Approval Date

2023-01-05

217410 / 2

Active Ingredient

FLUPHENAZINE HYDROCHLORIDE

Application Number

217410

Product Number

2

Dosage Form

-

Strength

2.5MG

Approval Date

2023-01-05

Regulatory Status

RX

2023
05 Jan
RX Application: 217410

Drug Name

FLUPHENAZINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

2023-01-05

217410 / 3

Active Ingredient

FLUPHENAZINE HYDROCHLORIDE

Application Number

217410

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

2023-01-05

Regulatory Status

RX

2023
05 Jan
RX Application: 217410

Drug Name

FLUPHENAZINE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2023-01-05

217410 / 4

Active Ingredient

FLUPHENAZINE HYDROCHLORIDE

Application Number

217410

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2023-01-05

Regulatory Status

RX

2024
17 Oct
RX Application: 219055

Drug Name

FLUVOXAMINE MALEATE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2024-10-17

219055 / 1

Active Ingredient

FLUVOXAMINE MALEATE

Application Number

219055

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2024-10-17

Regulatory Status

RX

2024
17 Oct
RX Application: 219055

Drug Name

FLUVOXAMINE MALEATE

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

2024-10-17

219055 / 2

Active Ingredient

FLUVOXAMINE MALEATE

Application Number

219055

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

2024-10-17

Regulatory Status

RX

2023
27 Apr
RX Application: 217293

Drug Name

GUANFACINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2023-04-27

217293 / 1

Active Ingredient

GUANFACINE HYDROCHLORIDE

Application Number

217293

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2023-04-27

Regulatory Status

RX

2023
27 Apr
RX Application: 217293

Drug Name

GUANFACINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2023-04-27

217293 / 2

Active Ingredient

GUANFACINE HYDROCHLORIDE

Application Number

217293

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2023-04-27

Regulatory Status

RX

2026
07 Apr
RX Application: 218509

Drug Name

IVERMECTIN

Product Number

1

Dosage Form

-

Strength

3MG

Approval Date

2026-04-07

218509 / 1

Active Ingredient

IVERMECTIN

Application Number

218509

Product Number

1

Dosage Form

-

Strength

3MG

Approval Date

2026-04-07

Regulatory Status

RX

2021
19 Jan
RX Application: 213271

Drug Name

LAMOTRIGINE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2021-01-19

213271 / 1

Active Ingredient

LAMOTRIGINE

Application Number

213271

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2021-01-19

Regulatory Status

RX

2021
19 Jan
RX Application: 213271

Drug Name

LAMOTRIGINE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2021-01-19

213271 / 2

Active Ingredient

LAMOTRIGINE

Application Number

213271

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2021-01-19

Regulatory Status

RX

2021
19 Jan
RX Application: 213271

Drug Name

LAMOTRIGINE

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2021-01-19

213271 / 3

Active Ingredient

LAMOTRIGINE

Application Number

213271

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2021-01-19

Regulatory Status

RX

2021
19 Jan
RX Application: 213271

Drug Name

LAMOTRIGINE

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2021-01-19

213271 / 4

Active Ingredient

LAMOTRIGINE

Application Number

213271

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2021-01-19

Regulatory Status

RX

2015
30 Nov
RX Application: 206528

Drug Name

MEMANTINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2015-11-30

206528 / 1

Active Ingredient

MEMANTINE HYDROCHLORIDE

Application Number

206528

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2015-11-30

Regulatory Status

RX

2015
30 Nov
RX Application: 206528

Drug Name

MEMANTINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2015-11-30

206528 / 2

Active Ingredient

MEMANTINE HYDROCHLORIDE

Application Number

206528

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2015-11-30

Regulatory Status

RX

2020
09 Apr
RX Application: 213651

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2020-04-09

213651 / 1

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

213651

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2020-04-09

Regulatory Status

RX

2020
09 Apr
RX Application: 213651

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

1GM

Approval Date

2020-04-09

213651 / 2

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

213651

Product Number

2

Dosage Form

-

Strength

1GM

Approval Date

2020-04-09

Regulatory Status

RX

2021
09 Mar
RX Application: 213962

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2021-03-09

213962 / 1

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

213962

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2021-03-09

Regulatory Status

RX

2021
09 Mar
RX Application: 213962

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

1GM

Approval Date

2021-03-09

213962 / 2

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

213962

Product Number

2

Dosage Form

-

Strength

1GM

Approval Date

2021-03-09

Regulatory Status

RX

2026
09 Feb
RX Application: 217408

Drug Name

METHAZOLAMIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2026-02-09

217408 / 1

Active Ingredient

METHAZOLAMIDE

Application Number

217408

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2026-02-09

Regulatory Status

RX

2026
09 Feb
RX Application: 217408

Drug Name

METHAZOLAMIDE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2026-02-09

217408 / 2

Active Ingredient

METHAZOLAMIDE

Application Number

217408

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2026-02-09

Regulatory Status

RX

2015
31 Jul
RX Application: 203438

Drug Name

MONTELUKAST SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE/PACKET

Approval Date

2015-07-31

203438 / 1

Active Ingredient

MONTELUKAST SODIUM

Application Number

203438

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE/PACKET

Approval Date

2015-07-31

Regulatory Status

RX

2022
06 Oct
RX Application: 213699

Drug Name

NAPROXEN AND ESOMEPRAZOLE MAGNESIUM

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE;375MG

Approval Date

2022-10-06

213699 / 1

Active Ingredient

ESOMEPRAZOLE MAGNESIUM; NAPROXEN

Application Number

213699

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE;375MG

Approval Date

2022-10-06

Regulatory Status

RX

2022
06 Oct
RX Application: 213699

Drug Name

NAPROXEN AND ESOMEPRAZOLE MAGNESIUM

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE;500MG

Approval Date

2022-10-06

213699 / 2

Active Ingredient

ESOMEPRAZOLE MAGNESIUM; NAPROXEN

Application Number

213699

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE;500MG

Approval Date

2022-10-06

Regulatory Status

RX

2016
15 Jul
RX Application: 204228

Drug Name

OMEPRAZOLE AND SODIUM BICARBONATE

Product Number

1

Dosage Form

-

Strength

20MG;1.1GM

Approval Date

2016-07-15

204228 / 1

Active Ingredient

OMEPRAZOLE; SODIUM BICARBONATE

Application Number

204228

Product Number

1

Dosage Form

-

Strength

20MG;1.1GM

Approval Date

2016-07-15

Regulatory Status

RX

2016
15 Jul
RX Application: 204228

Drug Name

OMEPRAZOLE AND SODIUM BICARBONATE

Product Number

2

Dosage Form

-

Strength

40MG;1.1GM

Approval Date

2016-07-15

204228 / 2

Active Ingredient

OMEPRAZOLE; SODIUM BICARBONATE

Application Number

204228

Product Number

2

Dosage Form

-

Strength

40MG;1.1GM

Approval Date

2016-07-15

Regulatory Status

RX

2016
27 Jul
RX Application: 205545

Drug Name

OMEPRAZOLE AND SODIUM BICARBONATE

Product Number

1

Dosage Form

-

Strength

20MG/PACKET;1.68GM/PACKET

Approval Date

2016-07-27

205545 / 1

Active Ingredient

OMEPRAZOLE; SODIUM BICARBONATE

Application Number

205545

Product Number

1

Dosage Form

-

Strength

20MG/PACKET;1.68GM/PACKET

Approval Date

2016-07-27

Regulatory Status

RX

2016
27 Jul
RX Application: 205545

Drug Name

OMEPRAZOLE AND SODIUM BICARBONATE

Product Number

2

Dosage Form

-

Strength

40MG/PACKET;1.68GM/PACKET

Approval Date

2016-07-27

205545 / 2

Active Ingredient

OMEPRAZOLE; SODIUM BICARBONATE

Application Number

205545

Product Number

2

Dosage Form

-

Strength

40MG/PACKET;1.68GM/PACKET

Approval Date

2016-07-27

Regulatory Status

RX

2020
27 May
RX Application: 212784

Drug Name

OSELTAMIVIR PHOSPHATE

Product Number

1

Dosage Form

-

Strength

EQ 6MG BASE/ML

Approval Date

2020-05-27

212784 / 1

Active Ingredient

OSELTAMIVIR PHOSPHATE

Application Number

212784

Product Number

1

Dosage Form

-

Strength

EQ 6MG BASE/ML

Approval Date

2020-05-27

Regulatory Status

RX

2024
22 Feb
RX Application: 217659

Drug Name

OXCARBAZEPINE

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2024-02-22

217659 / 1

Active Ingredient

OXCARBAZEPINE

Application Number

217659

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2024-02-22

Regulatory Status

RX

2024
22 Feb
RX Application: 217659

Drug Name

OXCARBAZEPINE

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2024-02-22

217659 / 2

Active Ingredient

OXCARBAZEPINE

Application Number

217659

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2024-02-22

Regulatory Status

RX

2024
22 Feb
RX Application: 217659

Drug Name

OXCARBAZEPINE

Product Number

3

Dosage Form

-

Strength

600MG

Approval Date

2024-02-22

217659 / 3

Active Ingredient

OXCARBAZEPINE

Application Number

217659

Product Number

3

Dosage Form

-

Strength

600MG

Approval Date

2024-02-22

Regulatory Status

RX

2019
28 Feb
RX Application: 211655

Drug Name

OXYBUTYNIN CHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2019-02-28

211655 / 1

Active Ingredient

OXYBUTYNIN CHLORIDE

Application Number

211655

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2019-02-28

Regulatory Status

RX

2019
28 Feb
RX Application: 211655

Drug Name

OXYBUTYNIN CHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2019-02-28

211655 / 2

Active Ingredient

OXYBUTYNIN CHLORIDE

Application Number

211655

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2019-02-28

Regulatory Status

RX

2019
28 Feb
RX Application: 211655

Drug Name

OXYBUTYNIN CHLORIDE

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

2019-02-28

211655 / 3

Active Ingredient

OXYBUTYNIN CHLORIDE

Application Number

211655

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

2019-02-28

Regulatory Status

RX

2024
26 Jun
RX Application: 218514

Drug Name

PALIPERIDONE

Product Number

1

Dosage Form

-

Strength

1.5MG

Approval Date

2024-06-26

218514 / 1

Active Ingredient

PALIPERIDONE

Application Number

218514

Product Number

1

Dosage Form

-

Strength

1.5MG

Approval Date

2024-06-26

Regulatory Status

RX

2024
26 Jun
RX Application: 218514

Drug Name

PALIPERIDONE

Product Number

2

Dosage Form

-

Strength

3MG

Approval Date

2024-06-26

218514 / 2

Active Ingredient

PALIPERIDONE

Application Number

218514

Product Number

2

Dosage Form

-

Strength

3MG

Approval Date

2024-06-26

Regulatory Status

RX

2024
26 Jun
RX Application: 218514

Drug Name

PALIPERIDONE

Product Number

3

Dosage Form

-

Strength

6MG

Approval Date

2024-06-26

218514 / 3

Active Ingredient

PALIPERIDONE

Application Number

218514

Product Number

3

Dosage Form

-

Strength

6MG

Approval Date

2024-06-26

Regulatory Status

RX

2024
26 Jun
RX Application: 218514

Drug Name

PALIPERIDONE

Product Number

4

Dosage Form

-

Strength

9MG

Approval Date

2024-06-26

218514 / 4

Active Ingredient

PALIPERIDONE

Application Number

218514

Product Number

4

Dosage Form

-

Strength

9MG

Approval Date

2024-06-26

Regulatory Status

RX

2023
09 Feb
RX Application: 217416

Drug Name

PANTOPRAZOLE SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2023-02-09

217416 / 1

Active Ingredient

PANTOPRAZOLE SODIUM

Application Number

217416

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2023-02-09

Regulatory Status

RX

2024
09 May
RX Application: 218515

Drug Name

PROCHLORPERAZINE MALEATE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2024-05-09

218515 / 1

Active Ingredient

PROCHLORPERAZINE MALEATE

Application Number

218515

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2024-05-09

Regulatory Status

RX

2024
09 May
RX Application: 218515

Drug Name

PROCHLORPERAZINE MALEATE

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2024-05-09

218515 / 2

Active Ingredient

PROCHLORPERAZINE MALEATE

Application Number

218515

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2024-05-09

Regulatory Status

RX

2026
16 Jan
RX Application: 219220

Drug Name

PRUCALOPRIDE SUCCINATE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2026-01-16

219220 / 1

Active Ingredient

PRUCALOPRIDE SUCCINATE

Application Number

219220

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2026-01-16

Regulatory Status

RX

2026
16 Jan
RX Application: 219220

Drug Name

PRUCALOPRIDE SUCCINATE

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2026-01-16

219220 / 2

Active Ingredient

PRUCALOPRIDE SUCCINATE

Application Number

219220

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2026-01-16

Regulatory Status

RX

2019
28 May
RX Application: 210054

Drug Name

RANOLAZINE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2019-05-28

210054 / 1

Active Ingredient

RANOLAZINE

Application Number

210054

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2019-05-28

Regulatory Status

RX

2019
28 May
RX Application: 210054

Drug Name

RANOLAZINE

Product Number

2

Dosage Form

-

Strength

1GM

Approval Date

2019-05-28

210054 / 2

Active Ingredient

RANOLAZINE

Application Number

210054

Product Number

2

Dosage Form

-

Strength

1GM

Approval Date

2019-05-28

Regulatory Status

RX

2011
24 Aug
RX Application: 201003

Drug Name

RISPERIDONE

Product Number

1

Dosage Form

-

Strength

0.25MG

Approval Date

2011-08-24

201003 / 1

Active Ingredient

RISPERIDONE

Application Number

201003

Product Number

1

Dosage Form

-

Strength

0.25MG

Approval Date

2011-08-24

Regulatory Status

RX

2011
24 Aug
RX Application: 201003

Drug Name

RISPERIDONE

Product Number

2

Dosage Form

-

Strength

0.5MG

Approval Date

2011-08-24

201003 / 2

Active Ingredient

RISPERIDONE

Application Number

201003

Product Number

2

Dosage Form

-

Strength

0.5MG

Approval Date

2011-08-24

Regulatory Status

RX

2011
24 Aug
RX Application: 201003

Drug Name

RISPERIDONE

Product Number

3

Dosage Form

-

Strength

1MG

Approval Date

2011-08-24

201003 / 3

Active Ingredient

RISPERIDONE

Application Number

201003

Product Number

3

Dosage Form

-

Strength

1MG

Approval Date

2011-08-24

Regulatory Status

RX

2011
24 Aug
RX Application: 201003

Drug Name

RISPERIDONE

Product Number

4

Dosage Form

-

Strength

2MG

Approval Date

2011-08-24

201003 / 4

Active Ingredient

RISPERIDONE

Application Number

201003

Product Number

4

Dosage Form

-

Strength

2MG

Approval Date

2011-08-24

Regulatory Status

RX

2011
24 Aug
RX Application: 201003

Drug Name

RISPERIDONE

Product Number

5

Dosage Form

-

Strength

3MG

Approval Date

2011-08-24

201003 / 5

Active Ingredient

RISPERIDONE

Application Number

201003

Product Number

5

Dosage Form

-

Strength

3MG

Approval Date

2011-08-24

Regulatory Status

RX

2011
24 Aug
RX Application: 201003

Drug Name

RISPERIDONE

Product Number

6

Dosage Form

-

Strength

4MG

Approval Date

2011-08-24

201003 / 6

Active Ingredient

RISPERIDONE

Application Number

201003

Product Number

6

Dosage Form

-

Strength

4MG

Approval Date

2011-08-24

Regulatory Status

RX

2018
12 Oct
RX Application: 206401

Drug Name

SILDENAFIL CITRATE

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2018-10-12

206401 / 1

Active Ingredient

SILDENAFIL CITRATE

Application Number

206401

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2018-10-12

Regulatory Status

RX

2018
12 Oct
RX Application: 206401

Drug Name

SILDENAFIL CITRATE

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2018-10-12

206401 / 2

Active Ingredient

SILDENAFIL CITRATE

Application Number

206401

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2018-10-12

Regulatory Status

RX

2018
12 Oct
RX Application: 206401

Drug Name

SILDENAFIL CITRATE

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2018-10-12

206401 / 3

Active Ingredient

SILDENAFIL CITRATE

Application Number

206401

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2018-10-12

Regulatory Status

RX

2018
04 May
RX Application: 210394

Drug Name

SILDENAFIL CITRATE

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2018-05-04

210394 / 1

Active Ingredient

SILDENAFIL CITRATE

Application Number

210394

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2018-05-04

Regulatory Status

RX

2019
27 Nov
RX Application: 212883

Drug Name

SILDENAFIL CITRATE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

2019-11-27

212883 / 1

Active Ingredient

SILDENAFIL CITRATE

Application Number

212883

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

2019-11-27

Regulatory Status

RX

2018
03 Dec
RX Application: 211060

Drug Name

SILODOSIN

Product Number

1

Dosage Form

-

Strength

4MG

Approval Date

2018-12-03

211060 / 1

Active Ingredient

SILODOSIN

Application Number

211060

Product Number

1

Dosage Form

-

Strength

4MG

Approval Date

2018-12-03

Regulatory Status

RX

2018
03 Dec
RX Application: 211060

Drug Name

SILODOSIN

Product Number

2

Dosage Form

-

Strength

8MG

Approval Date

2018-12-03

211060 / 2

Active Ingredient

SILODOSIN

Application Number

211060

Product Number

2

Dosage Form

-

Strength

8MG

Approval Date

2018-12-03

Regulatory Status

RX

2019
26 Mar
RX Application: 209654

Drug Name

TADALAFIL

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2019-03-26

209654 / 1

Active Ingredient

TADALAFIL

Application Number

209654

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2019-03-26

Regulatory Status

RX

2019
26 Mar
RX Application: 209654

Drug Name

TADALAFIL

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2019-03-26

209654 / 2

Active Ingredient

TADALAFIL

Application Number

209654

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2019-03-26

Regulatory Status

RX

2019
26 Mar
RX Application: 209654

Drug Name

TADALAFIL

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2019-03-26

209654 / 3

Active Ingredient

TADALAFIL

Application Number

209654

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2019-03-26

Regulatory Status

RX

2019
26 Mar
RX Application: 209654

Drug Name

TADALAFIL

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2019-03-26

209654 / 4

Active Ingredient

TADALAFIL

Application Number

209654

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2019-03-26

Regulatory Status

RX

2019
05 Feb
RX Application: 210392

Drug Name

TADALAFIL

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2019-02-05

210392 / 1

Active Ingredient

TADALAFIL

Application Number

210392

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2019-02-05

Regulatory Status

RX

2025
12 May
RX Application: 219482

Drug Name

TERAZOSIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2025-05-12

219482 / 1

Active Ingredient

TERAZOSIN HYDROCHLORIDE

Application Number

219482

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2025-05-12

Regulatory Status

RX

2025
12 May
RX Application: 219482

Drug Name

TERAZOSIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2025-05-12

219482 / 2

Active Ingredient

TERAZOSIN HYDROCHLORIDE

Application Number

219482

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2025-05-12

Regulatory Status

RX

2025
12 May
RX Application: 219482

Drug Name

TERAZOSIN HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2025-05-12

219482 / 3

Active Ingredient

TERAZOSIN HYDROCHLORIDE

Application Number

219482

Product Number

3

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2025-05-12

Regulatory Status

RX

2025
12 May
RX Application: 219482

Drug Name

TERAZOSIN HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2025-05-12

219482 / 4

Active Ingredient

TERAZOSIN HYDROCHLORIDE

Application Number

219482

Product Number

4

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2025-05-12

Regulatory Status

RX

2021
01 Jun
RX Application: 212943

Drug Name

TOFACITINIB CITRATE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2021-06-01

212943 / 1

Active Ingredient

TOFACITINIB CITRATE

Application Number

212943

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2021-06-01

Regulatory Status

RX

2025
19 Aug
RX Application: 219542

Drug Name

TOFACITINIB CITRATE

Product Number

1

Dosage Form

-

Strength

EQ 11MG BASE

Approval Date

2025-08-19

219542 / 1

Active Ingredient

TOFACITINIB CITRATE

Application Number

219542

Product Number

1

Dosage Form

-

Strength

EQ 11MG BASE

Approval Date

2025-08-19

Regulatory Status

RX

2020
19 May
RX Application: 213397

Drug Name

TOLTERODINE TARTRATE

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2020-05-19

213397 / 1

Active Ingredient

TOLTERODINE TARTRATE

Application Number

213397

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2020-05-19

Regulatory Status

RX

2020
19 May
RX Application: 213397

Drug Name

TOLTERODINE TARTRATE

Product Number

2

Dosage Form

-

Strength

4MG

Approval Date

2020-05-19

213397 / 2

Active Ingredient

TOLTERODINE TARTRATE

Application Number

213397

Product Number

2

Dosage Form

-

Strength

4MG

Approval Date

2020-05-19

Regulatory Status

RX

2023
15 Aug
RX Application: 215663

Drug Name

TOPIRAMATE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2023-08-15

215663 / 1

Active Ingredient

TOPIRAMATE

Application Number

215663

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2023-08-15

Regulatory Status

RX

2023
15 Aug
RX Application: 215663

Drug Name

TOPIRAMATE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2023-08-15

215663 / 2

Active Ingredient

TOPIRAMATE

Application Number

215663

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2023-08-15

Regulatory Status

RX

2023
15 Aug
RX Application: 215663

Drug Name

TOPIRAMATE

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2023-08-15

215663 / 3

Active Ingredient

TOPIRAMATE

Application Number

215663

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2023-08-15

Regulatory Status

RX

2023
15 Aug
RX Application: 215663

Drug Name

TOPIRAMATE

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2023-08-15

215663 / 4

Active Ingredient

TOPIRAMATE

Application Number

215663

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2023-08-15

Regulatory Status

RX

2025
02 Sep
RX Application: 219564

Drug Name

TOPIRAMATE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2025-09-02

219564 / 1

Active Ingredient

TOPIRAMATE

Application Number

219564

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2025-09-02

Regulatory Status

RX

2025
02 Sep
RX Application: 219564

Drug Name

TOPIRAMATE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2025-09-02

219564 / 2

Active Ingredient

TOPIRAMATE

Application Number

219564

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2025-09-02

Regulatory Status

RX

2025
02 Sep
RX Application: 219564

Drug Name

TOPIRAMATE

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2025-09-02

219564 / 3

Active Ingredient

TOPIRAMATE

Application Number

219564

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2025-09-02

Regulatory Status

RX

2025
02 Sep
RX Application: 219564

Drug Name

TOPIRAMATE

Product Number

4

Dosage Form

-

Strength

150MG

Approval Date

2025-09-02

219564 / 4

Active Ingredient

TOPIRAMATE

Application Number

219564

Product Number

4

Dosage Form

-

Strength

150MG

Approval Date

2025-09-02

Regulatory Status

RX

2025
02 Sep
RX Application: 219564

Drug Name

TOPIRAMATE

Product Number

5

Dosage Form

-

Strength

200MG

Approval Date

2025-09-02

219564 / 5

Active Ingredient

TOPIRAMATE

Application Number

219564

Product Number

5

Dosage Form

-

Strength

200MG

Approval Date

2025-09-02

Regulatory Status

RX

2019
26 Dec
RX Application: 212234

Drug Name

VALGANCICLOVIR HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 450MG BASE

Approval Date

2019-12-26

212234 / 1

Active Ingredient

VALGANCICLOVIR HYDROCHLORIDE

Application Number

212234

Product Number

1

Dosage Form

-

Strength

EQ 450MG BASE

Approval Date

2019-12-26

Regulatory Status

RX

2020
13 Jan
RX Application: 212890

Drug Name

VALGANCICLOVIR HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

2020-01-13

212890 / 1

Active Ingredient

VALGANCICLOVIR HYDROCHLORIDE

Application Number

212890

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

2020-01-13

Regulatory Status

RX

2024
19 Mar
RX Application: 213019

Drug Name

VARENICLINE TARTRATE

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE

Approval Date

2024-03-19

213019 / 1

Active Ingredient

VARENICLINE TARTRATE

Application Number

213019

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE

Approval Date

2024-03-19

Regulatory Status

RX

2024
19 Mar
RX Application: 213019

Drug Name

VARENICLINE TARTRATE

Product Number

2

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2024-03-19

213019 / 2

Active Ingredient

VARENICLINE TARTRATE

Application Number

213019

Product Number

2

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2024-03-19

Regulatory Status

RX

2023
12 Apr
RX Application: 214691

Drug Name

VENLAFAXINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 37.5MG BASE

Approval Date

2023-04-12

214691 / 1

Active Ingredient

VENLAFAXINE HYDROCHLORIDE

Application Number

214691

Product Number

1

Dosage Form

-

Strength

EQ 37.5MG BASE

Approval Date

2023-04-12

Regulatory Status

RX

2023
12 Apr
RX Application: 214691

Drug Name

VENLAFAXINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2023-04-12

214691 / 2

Active Ingredient

VENLAFAXINE HYDROCHLORIDE

Application Number

214691

Product Number

2

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2023-04-12

Regulatory Status

RX

2023
12 Apr
RX Application: 214691

Drug Name

VENLAFAXINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2023-04-12

214691 / 3

Active Ingredient

VENLAFAXINE HYDROCHLORIDE

Application Number

214691

Product Number

3

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2023-04-12

Regulatory Status

RX

2023
12 Apr
RX Application: 214691

Drug Name

VENLAFAXINE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 225MG BASE

Approval Date

2023-04-12

214691 / 4

Active Ingredient

VENLAFAXINE HYDROCHLORIDE

Application Number

214691

Product Number

4

Dosage Form

-

Strength

EQ 225MG BASE

Approval Date

2023-04-12

Regulatory Status

RX

2016
24 May
RX Application: 206181

Drug Name

VORICONAZOLE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2016-05-24

206181 / 1

Active Ingredient

VORICONAZOLE

Application Number

206181

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2016-05-24

Regulatory Status

RX

2016
24 May
RX Application: 206181

Drug Name

VORICONAZOLE

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2016-05-24

206181 / 2

Active Ingredient

VORICONAZOLE

Application Number

206181

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2016-05-24

Regulatory Status

RX

2016
20 May
RX Application: 204041

Drug Name

ZOLMITRIPTAN

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2016-05-20

204041 / 1

Active Ingredient

ZOLMITRIPTAN

Application Number

204041

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2016-05-20

Regulatory Status

RX

2016
20 May
RX Application: 204041

Drug Name

ZOLMITRIPTAN

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2016-05-20

204041 / 2

Active Ingredient

ZOLMITRIPTAN

Application Number

204041

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2016-05-20

Regulatory Status

RX

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Drug Status Breakdown
137 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

ALMOTRIPTAN MALATE

Application Number

205523

Product Number

1

Active Ingredient

ALMOTRIPTAN MALATE

Dosage Form

-

Strength

EQ 6.25MG BASE

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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