Granules India Limited
FDA Approved Drugs

Granules India Limited

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.

OTC RX Discontinued Unclassified
  • Total Records 83
  • Latest Approval Date Aug 08, 2024
  • Data Source FDA
  • First Approval Date Dec 21, 1993
All
83
View
Unclassified
2
View
Discontinued
21
View
OTC
12
View
RX
48
View
Company Overview

Company

Granules India Limited

Country

India

Website

Visit Website

Email

mail@granulesindia.com

Social Profiles

LinkedIn X / Twitter
Company Snapshot

Granules India Limited

2nd Floor, 3rd Block, My Home Hub, Madhapur, Hyderabad- 500 081 (TG)

India

granulesindia.com/ mail@granulesindia.com View on Map
FDA Approved Drug Records ( 83 records )
2019
16 Apr
OTC Application: 211544

Drug Name

ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

650MG

Approval Date

2019-04-16

211544 / 1

Active Ingredient

ACETAMINOPHEN

Application Number

211544

Product Number

1

Dosage Form

-

Strength

650MG

Approval Date

2019-04-16

Regulatory Status

OTC

2021
23 Feb
OTC Application: 214039

Drug Name

ACETAMINOPHEN, ASPIRIN AND CAFFEINE

Product Number

1

Dosage Form

-

Strength

250MG;250MG;65MG

Approval Date

2021-02-23

214039 / 1

Active Ingredient

ACETAMINOPHEN; ASPIRIN; CAFFEINE

Application Number

214039

Product Number

1

Dosage Form

-

Strength

250MG;250MG;65MG

Approval Date

2021-02-23

Regulatory Status

OTC

2017
22 Dec
OTC Application: 209274

Drug Name

CETIRIZINE HYDROCHLORIDE ALLERGY

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2017-12-22

209274 / 1

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

209274

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2017-12-22

Regulatory Status

OTC

2023
18 Oct
RX Application: 217427

Drug Name

ESOMEPRAZOLE MAGNESIUM

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2023-10-18

217427 / 1

Active Ingredient

ESOMEPRAZOLE MAGNESIUM

Application Number

217427

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2023-10-18

Regulatory Status

RX

2023
18 Oct
RX Application: 217427

Drug Name

ESOMEPRAZOLE MAGNESIUM

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2023-10-18

217427 / 2

Active Ingredient

ESOMEPRAZOLE MAGNESIUM

Application Number

217427

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2023-10-18

Regulatory Status

RX

2019
18 Oct
OTC Application: 211075

Drug Name

FEXOFENADINE HYDROCHLORIDE ALLERGY

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

2019-10-18

211075 / 1

Active Ingredient

FEXOFENADINE HYDROCHLORIDE

Application Number

211075

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

2019-10-18

Regulatory Status

OTC

2019
18 Oct
OTC Application: 211075

Drug Name

FEXOFENADINE HYDROCHLORIDE ALLERGY

Product Number

2

Dosage Form

-

Strength

180MG

Approval Date

2019-10-18

211075 / 2

Active Ingredient

FEXOFENADINE HYDROCHLORIDE

Application Number

211075

Product Number

2

Dosage Form

-

Strength

180MG

Approval Date

2019-10-18

Regulatory Status

OTC

2005
06 Apr
RX Application: 75360

Drug Name

GABAPENTIN

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2005-04-06

75360 / 1

Active Ingredient

GABAPENTIN

Application Number

75360

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2005-04-06

Regulatory Status

RX

2005
06 Apr
RX Application: 75360

Drug Name

GABAPENTIN

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2005-04-06

75360 / 2

Active Ingredient

GABAPENTIN

Application Number

75360

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2005-04-06

Regulatory Status

RX

2005
06 Apr
RX Application: 75360

Drug Name

GABAPENTIN

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

2005-04-06

75360 / 3

Active Ingredient

GABAPENTIN

Application Number

75360

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

2005-04-06

Regulatory Status

RX

2023
28 Mar
RX Application: 217116

Drug Name

GABAPENTIN

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2023-03-28

217116 / 1

Active Ingredient

GABAPENTIN

Application Number

217116

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2023-03-28

Regulatory Status

RX

2023
28 Mar
RX Application: 217116

Drug Name

GABAPENTIN

Product Number

2

Dosage Form

-

Strength

800MG

Approval Date

2023-03-28

217116 / 2

Active Ingredient

GABAPENTIN

Application Number

217116

Product Number

2

Dosage Form

-

Strength

800MG

Approval Date

2023-03-28

Regulatory Status

RX

2020
08 May
OTC Application: 213420

Drug Name

GUAIFENESIN

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2020-05-08

213420 / 1

Active Ingredient

GUAIFENESIN

Application Number

213420

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2020-05-08

Regulatory Status

OTC

2020
08 May
OTC Application: 213420

Drug Name

GUAIFENESIN

Product Number

2

Dosage Form

-

Strength

1.2GM

Approval Date

2020-05-08

213420 / 2

Active Ingredient

GUAIFENESIN

Application Number

213420

Product Number

2

Dosage Form

-

Strength

1.2GM

Approval Date

2020-05-08

Regulatory Status

OTC

2022
22 Aug
Discontinued Application: 216082

Drug Name

GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

600MG;60MG

Approval Date

2022-08-22

216082 / 1

Active Ingredient

GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE

Application Number

216082

Product Number

1

Dosage Form

-

Strength

600MG;60MG

Approval Date

2022-08-22

Regulatory Status

Discontinued

2022
22 Aug
Discontinued Application: 216082

Drug Name

GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

1.2GM;120MG

Approval Date

2022-08-22

216082 / 2

Active Ingredient

GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE

Application Number

216082

Product Number

2

Dosage Form

-

Strength

1.2GM;120MG

Approval Date

2022-08-22

Regulatory Status

Discontinued

2010
10 Dec
OTC Application: 79174

Drug Name

IBUPROFEN

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2010-12-10

79174 / 1

Active Ingredient

IBUPROFEN

Application Number

79174

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2010-12-10

Regulatory Status

OTC

2015
15 Sep
RX Application: 91625

Drug Name

IBUPROFEN

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

2015-09-15

91625 / 1

Active Ingredient

IBUPROFEN

Application Number

91625

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

2015-09-15

Regulatory Status

RX

2015
15 Sep
RX Application: 91625

Drug Name

IBUPROFEN

Product Number

2

Dosage Form

-

Strength

600MG

Approval Date

2015-09-15

91625 / 2

Active Ingredient

IBUPROFEN

Application Number

91625

Product Number

2

Dosage Form

-

Strength

600MG

Approval Date

2015-09-15

Regulatory Status

RX

2015
15 Sep
RX Application: 91625

Drug Name

IBUPROFEN

Product Number

3

Dosage Form

-

Strength

800MG

Approval Date

2015-09-15

91625 / 3

Active Ingredient

IBUPROFEN

Application Number

91625

Product Number

3

Dosage Form

-

Strength

800MG

Approval Date

2015-09-15

Regulatory Status

RX

2016
07 Oct
OTC Application: 202312

Drug Name

IBUPROFEN

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2016-10-07

202312 / 1

Active Ingredient

IBUPROFEN

Application Number

202312

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2016-10-07

Regulatory Status

OTC

2009
27 Jan
Discontinued Application: 78982

Drug Name

LAMOTRIGINE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2009-01-27

78982 / 1

Active Ingredient

LAMOTRIGINE

Application Number

78982

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2009-01-27

Regulatory Status

Discontinued

2009
27 Jan
Discontinued Application: 78982

Drug Name

LAMOTRIGINE

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2009-01-27

78982 / 2

Active Ingredient

LAMOTRIGINE

Application Number

78982

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2009-01-27

Regulatory Status

Discontinued

2009
27 Jan
Discontinued Application: 78982

Drug Name

LAMOTRIGINE

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2009-01-27

78982 / 3

Active Ingredient

LAMOTRIGINE

Application Number

78982

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2009-01-27

Regulatory Status

Discontinued

2009
27 Jan
Discontinued Application: 78982

Drug Name

LAMOTRIGINE

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2009-01-27

78982 / 4

Active Ingredient

LAMOTRIGINE

Application Number

78982

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2009-01-27

Regulatory Status

Discontinued

2023
13 Jun
Discontinued Application: 217878

Drug Name

LEVETIRACETAM

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2023-06-13

217878 / 1

Active Ingredient

LEVETIRACETAM

Application Number

217878

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2023-06-13

Regulatory Status

Discontinued

2023
13 Jun
Discontinued Application: 217878

Drug Name

LEVETIRACETAM

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2023-06-13

217878 / 2

Active Ingredient

LEVETIRACETAM

Application Number

217878

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2023-06-13

Regulatory Status

Discontinued

2023
13 Jun
Discontinued Application: 217878

Drug Name

LEVETIRACETAM

Product Number

3

Dosage Form

-

Strength

750MG

Approval Date

2023-06-13

217878 / 3

Active Ingredient

LEVETIRACETAM

Application Number

217878

Product Number

3

Dosage Form

-

Strength

750MG

Approval Date

2023-06-13

Regulatory Status

Discontinued

2023
13 Jun
Discontinued Application: 217878

Drug Name

LEVETIRACETAM

Product Number

4

Dosage Form

-

Strength

1GM

Approval Date

2023-06-13

217878 / 4

Active Ingredient

LEVETIRACETAM

Application Number

217878

Product Number

4

Dosage Form

-

Strength

1GM

Approval Date

2023-06-13

Regulatory Status

Discontinued

2013
26 Mar
Discontinued Application: 90486

Drug Name

LEVOCETIRIZINE DIHYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2013-03-26

90486 / 1

Active Ingredient

LEVOCETIRIZINE DIHYDROCHLORIDE

Application Number

90486

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2013-03-26

Regulatory Status

Discontinued

2022
29 Aug
Discontinued Application: 215981

Drug Name

LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE

Product Number

1

Dosage Form

-

Strength

2MG;125MG

Approval Date

2022-08-29

215981 / 1

Active Ingredient

LOPERAMIDE HYDROCHLORIDE; SIMETHICONE

Application Number

215981

Product Number

1

Dosage Form

-

Strength

2MG;125MG

Approval Date

2022-08-29

Regulatory Status

Discontinued

2019
23 Dec
OTC Application: 210722

Drug Name

LORATADINE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2019-12-23

210722 / 1

Active Ingredient

LORATADINE

Application Number

210722

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2019-12-23

Regulatory Status

OTC

2023
23 Feb
RX Application: 215959

Drug Name

LOSARTAN POTASSIUM

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2023-02-23

215959 / 1

Active Ingredient

LOSARTAN POTASSIUM

Application Number

215959

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2023-02-23

Regulatory Status

RX

2023
23 Feb
RX Application: 215959

Drug Name

LOSARTAN POTASSIUM

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2023-02-23

215959 / 2

Active Ingredient

LOSARTAN POTASSIUM

Application Number

215959

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2023-02-23

Regulatory Status

RX

2023
23 Feb
RX Application: 215959

Drug Name

LOSARTAN POTASSIUM

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2023-02-23

215959 / 3

Active Ingredient

LOSARTAN POTASSIUM

Application Number

215959

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2023-02-23

Regulatory Status

RX

2023
29 Sep
Discontinued Application: 218015

Drug Name

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

12.5MG;50MG

Approval Date

2023-09-29

218015 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM

Application Number

218015

Product Number

1

Dosage Form

-

Strength

12.5MG;50MG

Approval Date

2023-09-29

Regulatory Status

Discontinued

2023
29 Sep
Discontinued Application: 218015

Drug Name

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

12.5MG;100MG

Approval Date

2023-09-29

218015 / 2

Active Ingredient

HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM

Application Number

218015

Product Number

2

Dosage Form

-

Strength

12.5MG;100MG

Approval Date

2023-09-29

Regulatory Status

Discontinued

2023
29 Sep
Discontinued Application: 218015

Drug Name

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

Product Number

3

Dosage Form

-

Strength

25MG;100MG

Approval Date

2023-09-29

218015 / 3

Active Ingredient

HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM

Application Number

218015

Product Number

3

Dosage Form

-

Strength

25MG;100MG

Approval Date

2023-09-29

Regulatory Status

Discontinued

2010
22 Apr
RX Application: 90564

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2010-04-22

90564 / 1

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

90564

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2010-04-22

Regulatory Status

RX

2010
22 Apr
RX Application: 90564

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

850MG

Approval Date

2010-04-22

90564 / 2

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

90564

Product Number

2

Dosage Form

-

Strength

850MG

Approval Date

2010-04-22

Regulatory Status

RX

2010
22 Apr
RX Application: 90564

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

1GM

Approval Date

2010-04-22

90564 / 3

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

90564

Product Number

3

Dosage Form

-

Strength

1GM

Approval Date

2010-04-22

Regulatory Status

RX

2018
16 Mar
RX Application: 209313

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2018-03-16

209313 / 1

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

209313

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2018-03-16

Regulatory Status

RX

2018
16 Mar
RX Application: 209313

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

750MG

Approval Date

2018-03-16

209313 / 2

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

209313

Product Number

2

Dosage Form

-

Strength

750MG

Approval Date

2018-03-16

Regulatory Status

RX

2021
12 Jan
RX Application: 213344

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2021-01-12

213344 / 1

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

213344

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2021-01-12

Regulatory Status

RX

2021
12 Jan
RX Application: 213344

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

1GM

Approval Date

2021-01-12

213344 / 2

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

213344

Product Number

2

Dosage Form

-

Strength

1GM

Approval Date

2021-01-12

Regulatory Status

RX

2018
07 May
RX Application: 209312

Drug Name

METHOCARBAMOL

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2018-05-07

209312 / 1

Active Ingredient

METHOCARBAMOL

Application Number

209312

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2018-05-07

Regulatory Status

RX

2018
07 May
RX Application: 209312

Drug Name

METHOCARBAMOL

Product Number

2

Dosage Form

-

Strength

750MG

Approval Date

2018-05-07

209312 / 2

Active Ingredient

METHOCARBAMOL

Application Number

209312

Product Number

2

Dosage Form

-

Strength

750MG

Approval Date

2018-05-07

Regulatory Status

RX

2023
07 Aug
Discontinued Application: 216509

Drug Name

METOPROLOL SUCCINATE

Product Number

1

Dosage Form

-

Strength

EQ 25MG TARTRATE

Approval Date

2023-08-07

216509 / 1

Active Ingredient

METOPROLOL SUCCINATE

Application Number

216509

Product Number

1

Dosage Form

-

Strength

EQ 25MG TARTRATE

Approval Date

2023-08-07

Regulatory Status

Discontinued

2023
07 Aug
Discontinued Application: 216509

Drug Name

METOPROLOL SUCCINATE

Product Number

2

Dosage Form

-

Strength

EQ 50MG TARTRATE

Approval Date

2023-08-07

216509 / 2

Active Ingredient

METOPROLOL SUCCINATE

Application Number

216509

Product Number

2

Dosage Form

-

Strength

EQ 50MG TARTRATE

Approval Date

2023-08-07

Regulatory Status

Discontinued

2023
07 Aug
Discontinued Application: 216509

Drug Name

METOPROLOL SUCCINATE

Product Number

3

Dosage Form

-

Strength

EQ 100MG TARTRATE

Approval Date

2023-08-07

216509 / 3

Active Ingredient

METOPROLOL SUCCINATE

Application Number

216509

Product Number

3

Dosage Form

-

Strength

EQ 100MG TARTRATE

Approval Date

2023-08-07

Regulatory Status

Discontinued

2023
07 Aug
Discontinued Application: 216509

Drug Name

METOPROLOL SUCCINATE

Product Number

4

Dosage Form

-

Strength

EQ 200MG TARTRATE

Approval Date

2023-08-07

216509 / 4

Active Ingredient

METOPROLOL SUCCINATE

Application Number

216509

Product Number

4

Dosage Form

-

Strength

EQ 200MG TARTRATE

Approval Date

2023-08-07

Regulatory Status

Discontinued

2023
12 Jun
RX Application: 216916

Drug Name

METOPROLOL SUCCINATE

Product Number

1

Dosage Form

-

Strength

EQ 25MG TARTRATE

Approval Date

2023-06-12

216916 / 1

Active Ingredient

METOPROLOL SUCCINATE

Application Number

216916

Product Number

1

Dosage Form

-

Strength

EQ 25MG TARTRATE

Approval Date

2023-06-12

Regulatory Status

RX

2023
12 Jun
RX Application: 216916

Drug Name

METOPROLOL SUCCINATE

Product Number

2

Dosage Form

-

Strength

EQ 50MG TARTRATE

Approval Date

2023-06-12

216916 / 2

Active Ingredient

METOPROLOL SUCCINATE

Application Number

216916

Product Number

2

Dosage Form

-

Strength

EQ 50MG TARTRATE

Approval Date

2023-06-12

Regulatory Status

RX

2023
12 Jun
RX Application: 216916

Drug Name

METOPROLOL SUCCINATE

Product Number

3

Dosage Form

-

Strength

EQ 100MG TARTRATE

Approval Date

2023-06-12

216916 / 3

Active Ingredient

METOPROLOL SUCCINATE

Application Number

216916

Product Number

3

Dosage Form

-

Strength

EQ 100MG TARTRATE

Approval Date

2023-06-12

Regulatory Status

RX

2023
12 Jun
RX Application: 216916

Drug Name

METOPROLOL SUCCINATE

Product Number

4

Dosage Form

-

Strength

EQ 200MG TARTRATE

Approval Date

2023-06-12

216916 / 4

Active Ingredient

METOPROLOL SUCCINATE

Application Number

216916

Product Number

4

Dosage Form

-

Strength

EQ 200MG TARTRATE

Approval Date

2023-06-12

Regulatory Status

RX

1993
21 Dec
RX Application: 74140

Drug Name

NAPROXEN

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1993-12-21

74140 / 1

Active Ingredient

NAPROXEN

Application Number

74140

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1993-12-21

Regulatory Status

RX

1993
21 Dec
RX Application: 74140

Drug Name

NAPROXEN

Product Number

2

Dosage Form

-

Strength

375MG

Approval Date

1993-12-21

74140 / 2

Active Ingredient

NAPROXEN

Application Number

74140

Product Number

2

Dosage Form

-

Strength

375MG

Approval Date

1993-12-21

Regulatory Status

RX

1993
21 Dec
RX Application: 74140

Drug Name

NAPROXEN

Product Number

3

Dosage Form

-

Strength

500MG

Approval Date

1993-12-21

74140 / 3

Active Ingredient

NAPROXEN

Application Number

74140

Product Number

3

Dosage Form

-

Strength

500MG

Approval Date

1993-12-21

Regulatory Status

RX

2011
20 Sep
OTC Application: 91353

Drug Name

NAPROXEN SODIUM

Product Number

1

Dosage Form

-

Strength

220MG

Approval Date

2011-09-20

91353 / 1

Active Ingredient

NAPROXEN SODIUM

Application Number

91353

Product Number

1

Dosage Form

-

Strength

220MG

Approval Date

2011-09-20

Regulatory Status

OTC

2020
24 Sep
OTC Application: 213663

Drug Name

NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG;220MG

Approval Date

2020-09-24

213663 / 1

Active Ingredient

DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM

Application Number

213663

Product Number

1

Dosage Form

-

Strength

25MG;220MG

Approval Date

2020-09-24

Regulatory Status

OTC

2023
11 Dec
RX Application: 217282

Drug Name

PANTOPRAZOLE SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2023-12-11

217282 / 1

Active Ingredient

PANTOPRAZOLE SODIUM

Application Number

217282

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2023-12-11

Regulatory Status

RX

2023
11 Dec
RX Application: 217282

Drug Name

PANTOPRAZOLE SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2023-12-11

217282 / 2

Active Ingredient

PANTOPRAZOLE SODIUM

Application Number

217282

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2023-12-11

Regulatory Status

RX

-
Unclassified Application: 212615

Drug Name

PIRFENIDONE

Product Number

1

Dosage Form

-

Strength

267MG

Approval Date

-

212615 / 1

Active Ingredient

PIRFENIDONE

Application Number

212615

Product Number

1

Dosage Form

-

Strength

267MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 212615

Drug Name

PIRFENIDONE

Product Number

2

Dosage Form

-

Strength

801MG

Approval Date

-

212615 / 2

Active Ingredient

PIRFENIDONE

Application Number

212615

Product Number

2

Dosage Form

-

Strength

801MG

Approval Date

-

Regulatory Status

Unclassified

2020
21 Oct
RX Application: 214452

Drug Name

POTASSIUM CHLORIDE

Product Number

1

Dosage Form

-

Strength

10MEQ

Approval Date

2020-10-21

214452 / 1

Active Ingredient

POTASSIUM CHLORIDE

Application Number

214452

Product Number

1

Dosage Form

-

Strength

10MEQ

Approval Date

2020-10-21

Regulatory Status

RX

2020
21 Oct
RX Application: 214452

Drug Name

POTASSIUM CHLORIDE

Product Number

2

Dosage Form

-

Strength

20MEQ

Approval Date

2020-10-21

214452 / 2

Active Ingredient

POTASSIUM CHLORIDE

Application Number

214452

Product Number

2

Dosage Form

-

Strength

20MEQ

Approval Date

2020-10-21

Regulatory Status

RX

2021
16 Feb
RX Application: 214686

Drug Name

POTASSIUM CHLORIDE

Product Number

1

Dosage Form

-

Strength

8MEQ

Approval Date

2021-02-16

214686 / 1

Active Ingredient

POTASSIUM CHLORIDE

Application Number

214686

Product Number

1

Dosage Form

-

Strength

8MEQ

Approval Date

2021-02-16

Regulatory Status

RX

2021
16 Feb
RX Application: 214686

Drug Name

POTASSIUM CHLORIDE

Product Number

2

Dosage Form

-

Strength

10MEQ

Approval Date

2021-02-16

214686 / 2

Active Ingredient

POTASSIUM CHLORIDE

Application Number

214686

Product Number

2

Dosage Form

-

Strength

10MEQ

Approval Date

2021-02-16

Regulatory Status

RX

2018
20 Aug
Discontinued Application: 210243

Drug Name

RANITIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2018-08-20

210243 / 1

Active Ingredient

RANITIDINE HYDROCHLORIDE

Application Number

210243

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2018-08-20

Regulatory Status

Discontinued

2018
20 Aug
Discontinued Application: 210243

Drug Name

RANITIDINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2018-08-20

210243 / 2

Active Ingredient

RANITIDINE HYDROCHLORIDE

Application Number

210243

Product Number

2

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2018-08-20

Regulatory Status

Discontinued

2008
08 Jan
RX Application: 78403

Drug Name

SERTRALINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2008-01-08

78403 / 1

Active Ingredient

SERTRALINE HYDROCHLORIDE

Application Number

78403

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2008-01-08

Regulatory Status

RX

2008
08 Jan
RX Application: 78403

Drug Name

SERTRALINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2008-01-08

78403 / 2

Active Ingredient

SERTRALINE HYDROCHLORIDE

Application Number

78403

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2008-01-08

Regulatory Status

RX

2008
08 Jan
RX Application: 78403

Drug Name

SERTRALINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2008-01-08

78403 / 3

Active Ingredient

SERTRALINE HYDROCHLORIDE

Application Number

78403

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2008-01-08

Regulatory Status

RX

2024
08 Aug
RX Application: 218988

Drug Name

TRAZODONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2024-08-08

218988 / 1

Active Ingredient

TRAZODONE HYDROCHLORIDE

Application Number

218988

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2024-08-08

Regulatory Status

RX

2024
08 Aug
RX Application: 218988

Drug Name

TRAZODONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2024-08-08

218988 / 2

Active Ingredient

TRAZODONE HYDROCHLORIDE

Application Number

218988

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2024-08-08

Regulatory Status

RX

2024
08 Aug
RX Application: 218988

Drug Name

TRAZODONE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2024-08-08

218988 / 3

Active Ingredient

TRAZODONE HYDROCHLORIDE

Application Number

218988

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2024-08-08

Regulatory Status

RX

2024
08 Aug
RX Application: 218988

Drug Name

TRAZODONE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

300MG

Approval Date

2024-08-08

218988 / 4

Active Ingredient

TRAZODONE HYDROCHLORIDE

Application Number

218988

Product Number

4

Dosage Form

-

Strength

300MG

Approval Date

2024-08-08

Regulatory Status

RX

2023
18 May
RX Application: 217390

Drug Name

VENLAFAXINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 37.5MG BASE

Approval Date

2023-05-18

217390 / 1

Active Ingredient

VENLAFAXINE HYDROCHLORIDE

Application Number

217390

Product Number

1

Dosage Form

-

Strength

EQ 37.5MG BASE

Approval Date

2023-05-18

Regulatory Status

RX

2023
18 May
RX Application: 217390

Drug Name

VENLAFAXINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2023-05-18

217390 / 2

Active Ingredient

VENLAFAXINE HYDROCHLORIDE

Application Number

217390

Product Number

2

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2023-05-18

Regulatory Status

RX

2023
18 May
RX Application: 217390

Drug Name

VENLAFAXINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2023-05-18

217390 / 3

Active Ingredient

VENLAFAXINE HYDROCHLORIDE

Application Number

217390

Product Number

3

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2023-05-18

Regulatory Status

RX

2005
22 Dec
RX Application: 77636

Drug Name

ZONISAMIDE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2005-12-22

77636 / 1

Active Ingredient

ZONISAMIDE

Application Number

77636

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2005-12-22

Regulatory Status

RX

2006
27 Jul
RX Application: 77636

Drug Name

ZONISAMIDE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2006-07-27

77636 / 2

Active Ingredient

ZONISAMIDE

Application Number

77636

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2006-07-27

Regulatory Status

RX

2006
27 Jul
RX Application: 77636

Drug Name

ZONISAMIDE

Product Number

3

Dosage Form

-

Strength

25MG

Approval Date

2006-07-27

77636 / 3

Active Ingredient

ZONISAMIDE

Application Number

77636

Product Number

3

Dosage Form

-

Strength

25MG

Approval Date

2006-07-27

Regulatory Status

RX

Related Databases
  • FDA Inspections
    20 View
  • EDQM CEP
    31 View
  • KDMF
    0 View
  • Japan DMF
    2 View
  • Eudra GMP
    0 View
  • NDC Database
    95 View
  • FDA Approved Drugs Database
    83 View
Drug Status Breakdown
83 total
  • OTC
  • RX
  • Discontinued
  • Unclassified
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

ACETAMINOPHEN

Application Number

211544

Product Number

1

Active Ingredient

ACETAMINOPHEN

Dosage Form

-

Strength

650MG

FDA Approved Drug Data

Approved drug product information

Regular Updates

Data maintained from official sources

Structured Database

Searchable pharmaceutical data

Reliable Data

Organized FDA drug records

Create a New Buying Request

Fields marked with * are mandatory.

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