Aurobindo Pharma Limited OTC
FDA Approved Drugs

Aurobindo Pharma Limited OTC

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
  • Total Records 67
  • Latest Approval Date Aug 11, 2026
  • Data Source FDA
  • First Approval Date Feb 28, 1997
All
1128
View
Unclassified
43
View
Discontinued
121
View
OTC
67
View
RX
897
View
Company Overview

Company

Aurobindo Pharma Limited OTC

Country

India

Website

Visit Website

Email

info@aurobindo.com

Social Profiles

Company Snapshot

Aurobindo Pharma Limited OTC

Plot no. 2, Maitrivihar, Ameerpet, Hyderabad - 500038 Andhra Pradesh

India

www.aurobindo.com/ info@aurobindo.com View on Map
FDA Approved Drug Records ( 67 records )
2016
09 Nov
OTC Application: 207229

Drug Name

ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

650MG

Approval Date

2016-11-09

207229 / 1

Active Ingredient

ACETAMINOPHEN

Application Number

207229

Product Number

1

Dosage Form

-

Strength

650MG

Approval Date

2016-11-09

Regulatory Status

OTC

2024
26 Mar
OTC Application: 218359

Drug Name

ACETAMINOPHEN AND IBUPROFEN

Product Number

1

Dosage Form

-

Strength

250MG;125MG

Approval Date

2024-03-26

218359 / 1

Active Ingredient

ACETAMINOPHEN; IBUPROFEN

Application Number

218359

Product Number

1

Dosage Form

-

Strength

250MG;125MG

Approval Date

2024-03-26

Regulatory Status

OTC

2022
02 Feb
OTC Application: 211695

Drug Name

ACETAMINOPHEN, ASPIRIN AND CAFFEINE

Product Number

1

Dosage Form

-

Strength

250MG;250MG;65MG

Approval Date

2022-02-02

211695 / 1

Active Ingredient

ACETAMINOPHEN; ASPIRIN; CAFFEINE

Application Number

211695

Product Number

1

Dosage Form

-

Strength

250MG;250MG;65MG

Approval Date

2022-02-02

Regulatory Status

OTC

2015
08 Dec
OTC Application: 206867

Drug Name

ATHENTIA NEXT

Product Number

1

Dosage Form

-

Strength

1.5MG

Approval Date

2015-12-08

206867 / 1

Active Ingredient

LEVONORGESTREL

Application Number

206867

Product Number

1

Dosage Form

-

Strength

1.5MG

Approval Date

2015-12-08

Regulatory Status

OTC

2025
27 Jan
OTC Application: 216561

Drug Name

AZELASTINE HYDROCHLORIDE ALLERGY

Product Number

1

Dosage Form

-

Strength

0.2055MG/SPRAY

Approval Date

2025-01-27

216561 / 1

Active Ingredient

AZELASTINE HYDROCHLORIDE

Application Number

216561

Product Number

1

Dosage Form

-

Strength

0.2055MG/SPRAY

Approval Date

2025-01-27

Regulatory Status

OTC

2020
11 Sep
OTC Application: 213557

Drug Name

CETIRIZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2020-09-11

213557 / 1

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

213557

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2020-09-11

Regulatory Status

OTC

2015
05 Aug
OTC Application: 90760

Drug Name

CETIRIZINE HYDROCHLORIDE ALLERGY

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2015-08-05

90760 / 1

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

90760

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2015-08-05

Regulatory Status

OTC

2015
05 Aug
OTC Application: 90760

Drug Name

CETIRIZINE HYDROCHLORIDE ALLERGY

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2015-08-05

90760 / 3

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

90760

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2015-08-05

Regulatory Status

OTC

2018
20 Jul
OTC Application: 209107

Drug Name

CETIRIZINE HYDROCHLORIDE ALLERGY

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2018-07-20

209107 / 1

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

209107

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2018-07-20

Regulatory Status

OTC

2015
05 Aug
OTC Application: 90760

Drug Name

CETIRIZINE HYDROCHLORIDE HIVES RELIEF

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2015-08-05

90760 / 2

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

90760

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2015-08-05

Regulatory Status

OTC

2015
05 Aug
OTC Application: 90760

Drug Name

CETIRIZINE HYDROCHLORIDE HIVES RELIEF

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2015-08-05

90760 / 4

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

90760

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2015-08-05

Regulatory Status

OTC

2018
20 Jul
OTC Application: 209107

Drug Name

CETIRIZINE HYDROCHLORIDE HIVES RELIEF

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2018-07-20

209107 / 2

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

209107

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2018-07-20

Regulatory Status

OTC

2010
02 Feb
OTC Application: 90750

Drug Name

CHILDRENS CETIRIZINE HYDROCHLORIDE ALLERGY

Product Number

2

Dosage Form

-

Strength

5MG/5ML

Approval Date

2010-02-02

90750 / 2

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

90750

Product Number

2

Dosage Form

-

Strength

5MG/5ML

Approval Date

2010-02-02

Regulatory Status

OTC

2010
02 Feb
OTC Application: 90750

Drug Name

CHILDRENS CETIRIZINE HYDROCHLORIDE HIVES RELIEF

Product Number

1

Dosage Form

-

Strength

5MG/5ML

Approval Date

2010-02-02

90750 / 1

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

90750

Product Number

1

Dosage Form

-

Strength

5MG/5ML

Approval Date

2010-02-02

Regulatory Status

OTC

2014
19 Nov
OTC Application: 202039

Drug Name

CHILDRENS FEXOFENADINE HYDROCHLORIDE ALLERGY

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

2014-11-19

202039 / 1

Active Ingredient

FEXOFENADINE HYDROCHLORIDE

Application Number

202039

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

2014-11-19

Regulatory Status

OTC

2026
15 Apr
OTC Application: 218417

Drug Name

DEXTROMETHORPHAN POLISTIREX

Product Number

1

Dosage Form

-

Strength

EQ 30MG HYDROBROMIDE/5ML

Approval Date

2026-04-15

218417 / 1

Active Ingredient

DEXTROMETHORPHAN POLISTIREX

Application Number

218417

Product Number

1

Dosage Form

-

Strength

EQ 30MG HYDROBROMIDE/5ML

Approval Date

2026-04-15

Regulatory Status

OTC

2024
01 Mar
OTC Application: 217090

Drug Name

DOCOSANOL

Product Number

1

Dosage Form

-

Strength

10%

Approval Date

2024-03-01

217090 / 1

Active Ingredient

DOCOSANOL

Application Number

217090

Product Number

1

Dosage Form

-

Strength

10%

Approval Date

2024-03-01

Regulatory Status

OTC

2017
16 Oct
OTC Application: 209339

Drug Name

ESOMEPRAZOLE MAGNESIUM

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2017-10-16

209339 / 1

Active Ingredient

ESOMEPRAZOLE MAGNESIUM

Application Number

209339

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2017-10-16

Regulatory Status

OTC

2023
12 Jul
OTC Application: 214473

Drug Name

ESOMEPRAZOLE MAGNESIUM

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2023-07-12

214473 / 1

Active Ingredient

ESOMEPRAZOLE MAGNESIUM

Application Number

214473

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2023-07-12

Regulatory Status

OTC

2016
26 Apr
OTC Application: 206531

Drug Name

FAMOTIDINE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2016-04-26

206531 / 1

Active Ingredient

FAMOTIDINE

Application Number

206531

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2016-04-26

Regulatory Status

OTC

2016
26 Apr
OTC Application: 206531

Drug Name

FAMOTIDINE

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2016-04-26

206531 / 2

Active Ingredient

FAMOTIDINE

Application Number

206531

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2016-04-26

Regulatory Status

OTC

2023
23 May
OTC Application: 213466

Drug Name

FEXOFENADINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

30MG/5ML

Approval Date

2023-05-23

213466 / 1

Active Ingredient

FEXOFENADINE HYDROCHLORIDE

Application Number

213466

Product Number

1

Dosage Form

-

Strength

30MG/5ML

Approval Date

2023-05-23

Regulatory Status

OTC

2014
19 Nov
OTC Application: 202039

Drug Name

FEXOFENADINE HYDROCHLORIDE ALLERGY

Product Number

2

Dosage Form

-

Strength

60MG

Approval Date

2014-11-19

202039 / 2

Active Ingredient

FEXOFENADINE HYDROCHLORIDE

Application Number

202039

Product Number

2

Dosage Form

-

Strength

60MG

Approval Date

2014-11-19

Regulatory Status

OTC

2014
19 Nov
OTC Application: 202039

Drug Name

FEXOFENADINE HYDROCHLORIDE ALLERGY

Product Number

3

Dosage Form

-

Strength

180MG

Approval Date

2014-11-19

202039 / 3

Active Ingredient

FEXOFENADINE HYDROCHLORIDE

Application Number

202039

Product Number

3

Dosage Form

-

Strength

180MG

Approval Date

2014-11-19

Regulatory Status

OTC

2017
30 Oct
OTC Application: 209116

Drug Name

FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

60MG;120MG

Approval Date

2017-10-30

209116 / 1

Active Ingredient

FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

Application Number

209116

Product Number

1

Dosage Form

-

Strength

60MG;120MG

Approval Date

2017-10-30

Regulatory Status

OTC

2025
17 Apr
OTC Application: 215232

Drug Name

FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

180MG;240MG

Approval Date

2025-04-17

215232 / 1

Active Ingredient

FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

Application Number

215232

Product Number

1

Dosage Form

-

Strength

180MG;240MG

Approval Date

2025-04-17

Regulatory Status

OTC

2024
10 May
OTC Application: 217088

Drug Name

FLUTICASONE PROPIONATE

Product Number

1

Dosage Form

-

Strength

0.05MG/SPRAY

Approval Date

2024-05-10

217088 / 1

Active Ingredient

FLUTICASONE PROPIONATE

Application Number

217088

Product Number

1

Dosage Form

-

Strength

0.05MG/SPRAY

Approval Date

2024-05-10

Regulatory Status

OTC

2019
21 Oct
OTC Application: 210453

Drug Name

GUAIFENESIN

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2019-10-21

210453 / 1

Active Ingredient

GUAIFENESIN

Application Number

210453

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2019-10-21

Regulatory Status

OTC

2019
21 Oct
OTC Application: 210453

Drug Name

GUAIFENESIN

Product Number

2

Dosage Form

-

Strength

1.2GM

Approval Date

2019-10-21

210453 / 2

Active Ingredient

GUAIFENESIN

Application Number

210453

Product Number

2

Dosage Form

-

Strength

1.2GM

Approval Date

2019-10-21

Regulatory Status

OTC

2017
17 Mar
OTC Application: 206941

Drug Name

GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE

Product Number

1

Dosage Form

-

Strength

30MG;600MG

Approval Date

2017-03-17

206941 / 1

Active Ingredient

DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN

Application Number

206941

Product Number

1

Dosage Form

-

Strength

30MG;600MG

Approval Date

2017-03-17

Regulatory Status

OTC

2017
17 Mar
OTC Application: 206941

Drug Name

GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE

Product Number

2

Dosage Form

-

Strength

60MG;1.2GM

Approval Date

2017-03-17

206941 / 2

Active Ingredient

DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN

Application Number

206941

Product Number

2

Dosage Form

-

Strength

60MG;1.2GM

Approval Date

2017-03-17

Regulatory Status

OTC

2020
25 Mar
OTC Application: 213203

Drug Name

GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

600MG;60MG

Approval Date

2020-03-25

213203 / 1

Active Ingredient

GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE

Application Number

213203

Product Number

1

Dosage Form

-

Strength

600MG;60MG

Approval Date

2020-03-25

Regulatory Status

OTC

2020
25 Mar
OTC Application: 213203

Drug Name

GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

1.2GM;120MG

Approval Date

2020-03-25

213203 / 2

Active Ingredient

GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE

Application Number

213203

Product Number

2

Dosage Form

-

Strength

1.2GM;120MG

Approval Date

2020-03-25

Regulatory Status

OTC

2018
29 Jun
OTC Application: 207753

Drug Name

IBUPROFEN

Product Number

1

Dosage Form

-

Strength

EQ 200MG FREE ACID AND POTASSIUM SALT

Approval Date

2018-06-29

207753 / 1

Active Ingredient

IBUPROFEN

Application Number

207753

Product Number

1

Dosage Form

-

Strength

EQ 200MG FREE ACID AND POTASSIUM SALT

Approval Date

2018-06-29

Regulatory Status

OTC

2017
08 Nov
OTC Application: 208865

Drug Name

IBUPROFEN

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2017-11-08

208865 / 1

Active Ingredient

IBUPROFEN

Application Number

208865

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2017-11-08

Regulatory Status

OTC

2018
17 Apr
OTC Application: 209179

Drug Name

IBUPROFEN

Product Number

1

Dosage Form

-

Strength

100MG/5ML

Approval Date

2018-04-17

209179 / 1

Active Ingredient

IBUPROFEN

Application Number

209179

Product Number

1

Dosage Form

-

Strength

100MG/5ML

Approval Date

2018-04-17

Regulatory Status

OTC

2024
08 Apr
OTC Application: 213506

Drug Name

IBUPROFEN

Product Number

1

Dosage Form

-

Strength

40MG/ML

Approval Date

2024-04-08

213506 / 1

Active Ingredient

IBUPROFEN

Application Number

213506

Product Number

1

Dosage Form

-

Strength

40MG/ML

Approval Date

2024-04-08

Regulatory Status

OTC

2023
14 Sep
OTC Application: 215777

Drug Name

IBUPROFEN

Product Number

1

Dosage Form

-

Strength

EQ 200MG FREE ACID AND POTASSIUM SALT

Approval Date

2023-09-14

215777 / 1

Active Ingredient

IBUPROFEN

Application Number

215777

Product Number

1

Dosage Form

-

Strength

EQ 200MG FREE ACID AND POTASSIUM SALT

Approval Date

2023-09-14

Regulatory Status

OTC

2022
31 May
OTC Application: 216204

Drug Name

IBUPROFEN AND DIPHENHYDRAMINE CITRATE

Product Number

1

Dosage Form

-

Strength

38MG;200MG

Approval Date

2022-05-31

216204 / 1

Active Ingredient

DIPHENHYDRAMINE CITRATE; IBUPROFEN

Application Number

216204

Product Number

1

Dosage Form

-

Strength

38MG;200MG

Approval Date

2022-05-31

Regulatory Status

OTC

2019
14 Feb
OTC Application: 210676

Drug Name

IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG;EQ 200MG FREE ACID AND POTASSIUM SALT

Approval Date

2019-02-14

210676 / 1

Active Ingredient

DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN

Application Number

210676

Product Number

1

Dosage Form

-

Strength

25MG;EQ 200MG FREE ACID AND POTASSIUM SALT

Approval Date

2019-02-14

Regulatory Status

OTC

2017
01 Dec
OTC Application: 209235

Drug Name

IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 200MG FREE ACID AND POTASSIUM SALT;30MG

Approval Date

2017-12-01

209235 / 1

Active Ingredient

IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE

Application Number

209235

Product Number

1

Dosage Form

-

Strength

EQ 200MG FREE ACID AND POTASSIUM SALT;30MG

Approval Date

2017-12-01

Regulatory Status

OTC

2023
10 Mar
OTC Application: 213565

Drug Name

IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

200MG;30MG

Approval Date

2023-03-10

213565 / 1

Active Ingredient

IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE

Application Number

213565

Product Number

1

Dosage Form

-

Strength

200MG;30MG

Approval Date

2023-03-10

Regulatory Status

OTC

2015
15 Dec
OTC Application: 206548

Drug Name

LOPERAMIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2015-12-15

206548 / 1

Active Ingredient

LOPERAMIDE HYDROCHLORIDE

Application Number

206548

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2015-12-15

Regulatory Status

OTC

2025
29 Dec
OTC Application: 220372

Drug Name

LOPERAMIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2025-12-29

220372 / 1

Active Ingredient

LOPERAMIDE HYDROCHLORIDE

Application Number

220372

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2025-12-29

Regulatory Status

OTC

2020
14 Dec
OTC Application: 211059

Drug Name

LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE

Product Number

1

Dosage Form

-

Strength

2MG;125MG

Approval Date

2020-12-14

211059 / 1

Active Ingredient

LOPERAMIDE HYDROCHLORIDE; SIMETHICONE

Application Number

211059

Product Number

1

Dosage Form

-

Strength

2MG;125MG

Approval Date

2020-12-14

Regulatory Status

OTC

2018
16 Apr
OTC Application: 208314

Drug Name

LORATADINE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2018-04-16

208314 / 1

Active Ingredient

LORATADINE

Application Number

208314

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2018-04-16

Regulatory Status

OTC

2018
11 Apr
OTC Application: 208477

Drug Name

LORATADINE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2018-04-11

208477 / 1

Active Ingredient

LORATADINE

Application Number

208477

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2018-04-11

Regulatory Status

OTC

2018
29 Jun
OTC Application: 208931

Drug Name

LORATADINE

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2018-06-29

208931 / 1

Active Ingredient

LORATADINE

Application Number

208931

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2018-06-29

Regulatory Status

OTC

2023
24 Mar
OTC Application: 211900

Drug Name

LORATADINE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2023-03-24

211900 / 1

Active Ingredient

LORATADINE

Application Number

211900

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2023-03-24

Regulatory Status

OTC

1997
28 Feb
OTC Application: 74767

Drug Name

MINOXIDIL (FOR MEN)

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1997-02-28

74767 / 1

Active Ingredient

MINOXIDIL

Application Number

74767

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

1997-02-28

Regulatory Status

OTC

2024
22 Apr
OTC Application: 218616

Drug Name

MINOXIDIL (FOR MEN)

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

2024-04-22

218616 / 1

Active Ingredient

MINOXIDIL

Application Number

218616

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

2024-04-22

Regulatory Status

OTC

1997
25 Nov
OTC Application: 74767

Drug Name

MINOXIDIL (FOR WOMEN)

Product Number

2

Dosage Form

-

Strength

2%

Approval Date

1997-11-25

74767 / 2

Active Ingredient

MINOXIDIL

Application Number

74767

Product Number

2

Dosage Form

-

Strength

2%

Approval Date

1997-11-25

Regulatory Status

OTC

2024
22 Apr
OTC Application: 218616

Drug Name

MINOXIDIL (FOR WOMEN)

Product Number

2

Dosage Form

-

Strength

5%

Approval Date

2024-04-22

218616 / 2

Active Ingredient

MINOXIDIL

Application Number

218616

Product Number

2

Dosage Form

-

Strength

5%

Approval Date

2024-04-22

Regulatory Status

OTC

2003
27 Feb
OTC Application: 75438

Drug Name

MINOXIDIL EXTRA STRENGTH (FOR MEN)

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

2003-02-27

75438 / 1

Active Ingredient

MINOXIDIL

Application Number

75438

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

2003-02-27

Regulatory Status

OTC

2016
18 Mar
OTC Application: 205497

Drug Name

NAPROXEN SODIUM

Product Number

1

Dosage Form

-

Strength

220MG

Approval Date

2016-03-18

205497 / 1

Active Ingredient

NAPROXEN SODIUM

Application Number

205497

Product Number

1

Dosage Form

-

Strength

220MG

Approval Date

2016-03-18

Regulatory Status

OTC

2022
01 Jun
OTC Application: 211360

Drug Name

NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

220MG;120MG

Approval Date

2022-06-01

211360 / 1

Active Ingredient

NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE

Application Number

211360

Product Number

1

Dosage Form

-

Strength

220MG;120MG

Approval Date

2022-06-01

Regulatory Status

OTC

2021
03 Aug
OTC Application: 213266

Drug Name

NICOTINE POLACRILEX

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2021-08-03

213266 / 1

Active Ingredient

NICOTINE POLACRILEX

Application Number

213266

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2021-08-03

Regulatory Status

OTC

2021
03 Aug
OTC Application: 213266

Drug Name

NICOTINE POLACRILEX

Product Number

2

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2021-08-03

213266 / 2

Active Ingredient

NICOTINE POLACRILEX

Application Number

213266

Product Number

2

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2021-08-03

Regulatory Status

OTC

2022
13 May
OTC Application: 215357

Drug Name

NICOTINE POLACRILEX

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2022-05-13

215357 / 1

Active Ingredient

NICOTINE POLACRILEX

Application Number

215357

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2022-05-13

Regulatory Status

OTC

2022
13 May
OTC Application: 215357

Drug Name

NICOTINE POLACRILEX

Product Number

2

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2022-05-13

215357 / 2

Active Ingredient

NICOTINE POLACRILEX

Application Number

215357

Product Number

2

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2022-05-13

Regulatory Status

OTC

2016
07 Nov
OTC Application: 204923

Drug Name

OMEPRAZOLE AND SODIUM BICARBONATE

Product Number

1

Dosage Form

-

Strength

20MG;1.1GM

Approval Date

2016-11-07

204923 / 1

Active Ingredient

OMEPRAZOLE; SODIUM BICARBONATE

Application Number

204923

Product Number

1

Dosage Form

-

Strength

20MG;1.1GM

Approval Date

2016-11-07

Regulatory Status

OTC

2018
06 Jun
OTC Application: 206877

Drug Name

OMEPRAZOLE MAGNESIUM

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2018-06-06

206877 / 1

Active Ingredient

OMEPRAZOLE MAGNESIUM

Application Number

206877

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2018-06-06

Regulatory Status

OTC

2018
09 Apr
OTC Application: 209017

Drug Name

POLYETHYLENE GLYCOL 3350

Product Number

1

Dosage Form

-

Strength

17GM/SCOOPFUL

Approval Date

2018-04-09

209017 / 1

Active Ingredient

POLYETHYLENE GLYCOL 3350

Application Number

209017

Product Number

1

Dosage Form

-

Strength

17GM/SCOOPFUL

Approval Date

2018-04-09

Regulatory Status

OTC

2024
23 Apr
OTC Application: 209017

Drug Name

POLYETHYLENE GLYCOL 3350

Product Number

2

Dosage Form

-

Strength

17GM/PACKET

Approval Date

2024-04-23

209017 / 2

Active Ingredient

POLYETHYLENE GLYCOL 3350

Application Number

209017

Product Number

2

Dosage Form

-

Strength

17GM/PACKET

Approval Date

2024-04-23

Regulatory Status

OTC

2017
09 Jun
OTC Application: 209008

Drug Name

PSEUDOEPHEDRINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

120MG

Approval Date

2017-06-09

209008 / 1

Active Ingredient

PSEUDOEPHEDRINE HYDROCHLORIDE

Application Number

209008

Product Number

1

Dosage Form

-

Strength

120MG

Approval Date

2017-06-09

Regulatory Status

OTC

2025
29 Dec
OTC Application: 218854

Drug Name

PSEUDOEPHEDRINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

240MG

Approval Date

2025-12-29

218854 / 1

Active Ingredient

PSEUDOEPHEDRINE HYDROCHLORIDE

Application Number

218854

Product Number

1

Dosage Form

-

Strength

240MG

Approval Date

2025-12-29

Regulatory Status

OTC

2026
11 Aug
OTC Application: 220110

Drug Name

TRIAMCINOLONE ACETONIDE

Product Number

1

Dosage Form

-

Strength

0.055MG/SPRAY

Approval Date

2026-08-11

220110 / 1

Active Ingredient

TRIAMCINOLONE ACETONIDE

Application Number

220110

Product Number

1

Dosage Form

-

Strength

0.055MG/SPRAY

Approval Date

2026-08-11

Regulatory Status

OTC

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Drug Status Breakdown
67 total
  • OTC
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

207229

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

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