Sun Pharmaceutical Industries Limited OTC
FDA Approved Drugs

Sun Pharmaceutical Industries 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 21
  • Latest Approval Date Apr 25, 2025
  • Data Source FDA
  • First Approval Date Aug 18, 2003
All
1031
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Unclassified
41
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Discontinued
698
View
OTC
21
View
RX
271
View
Company Overview

Company

Sun Pharmaceutical Industries Limited OTC

Country

India

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Company Snapshot

Sun Pharmaceutical Industries Limited OTC

Sun House, CTS No. 201 B/1, Western Express Highway, Goregaon (E), Mumbai 400063

India

sunpharma.com/ View on Map
FDA Approved Drug Records ( 21 records )
2007
27 Dec
OTC Application: 77498

Drug Name

CETIRIZINE HYDROCHLORIDE ALLERGY

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2007-12-27

77498 / 1

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

77498

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2007-12-27

Regulatory Status

OTC

2007
27 Dec
OTC Application: 77498

Drug Name

CETIRIZINE HYDROCHLORIDE ALLERGY

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2007-12-27

77498 / 2

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

77498

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2007-12-27

Regulatory Status

OTC

2012
28 Sep
OTC Application: 90922

Drug Name

CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG;120MG

Approval Date

2012-09-28

90922 / 1

Active Ingredient

CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

Application Number

90922

Product Number

1

Dosage Form

-

Strength

5MG;120MG

Approval Date

2012-09-28

Regulatory Status

OTC

2007
27 Dec
OTC Application: 77498

Drug Name

CETIRIZINE HYDROCHLORIDE HIVES

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

2007-12-27

77498 / 3

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

77498

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

2007-12-27

Regulatory Status

OTC

2007
27 Dec
OTC Application: 77498

Drug Name

CETIRIZINE HYDROCHLORIDE HIVES

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2007-12-27

77498 / 4

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

77498

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2007-12-27

Regulatory Status

OTC

2020
04 May
OTC Application: 212866

Drug Name

ESOMEPRAZOLE MAGNESIUM

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2020-05-04

212866 / 1

Active Ingredient

ESOMEPRAZOLE MAGNESIUM

Application Number

212866

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2020-05-04

Regulatory Status

OTC

2012
06 Feb
OTC Application: 91567

Drug Name

FEXOFENADINE HYDROCHLORIDE ALLERGY

Product Number

6

Dosage Form

-

Strength

180MG

Approval Date

2012-02-06

91567 / 6

Active Ingredient

FEXOFENADINE HYDROCHLORIDE

Application Number

91567

Product Number

6

Dosage Form

-

Strength

180MG

Approval Date

2012-02-06

Regulatory Status

OTC

2015
29 Jan
OTC Application: 90818

Drug Name

FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

60MG;120MG

Approval Date

2015-01-29

90818 / 1

Active Ingredient

FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

Application Number

90818

Product Number

1

Dosage Form

-

Strength

60MG;120MG

Approval Date

2015-01-29

Regulatory Status

OTC

2012
06 Feb
OTC Application: 91567

Drug Name

FEXOFENADINE HYDROCHLORIDE HIVES

Product Number

5

Dosage Form

-

Strength

180MG

Approval Date

2012-02-06

91567 / 5

Active Ingredient

FEXOFENADINE HYDROCHLORIDE

Application Number

91567

Product Number

5

Dosage Form

-

Strength

180MG

Approval Date

2012-02-06

Regulatory Status

OTC

2021
01 Jul
OTC Application: 214781

Drug Name

GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE

Product Number

1

Dosage Form

-

Strength

30MG;600MG

Approval Date

2021-07-01

214781 / 1

Active Ingredient

DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN

Application Number

214781

Product Number

1

Dosage Form

-

Strength

30MG;600MG

Approval Date

2021-07-01

Regulatory Status

OTC

2021
01 Jul
OTC Application: 214781

Drug Name

GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE

Product Number

2

Dosage Form

-

Strength

60MG;1.2GM

Approval Date

2021-07-01

214781 / 2

Active Ingredient

DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN

Application Number

214781

Product Number

2

Dosage Form

-

Strength

60MG;1.2GM

Approval Date

2021-07-01

Regulatory Status

OTC

2020
28 Apr
OTC Application: 212542

Drug Name

GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

600MG;60MG

Approval Date

2020-04-28

212542 / 1

Active Ingredient

GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE

Application Number

212542

Product Number

1

Dosage Form

-

Strength

600MG;60MG

Approval Date

2020-04-28

Regulatory Status

OTC

2020
28 Apr
OTC Application: 212542

Drug Name

GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

1.2GM;120MG

Approval Date

2020-04-28

212542 / 2

Active Ingredient

GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE

Application Number

212542

Product Number

2

Dosage Form

-

Strength

1.2GM;120MG

Approval Date

2020-04-28

Regulatory Status

OTC

2003
18 Aug
OTC Application: 76134

Drug Name

LORATADINE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2003-08-18

76134 / 1

Active Ingredient

LORATADINE

Application Number

76134

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2003-08-18

Regulatory Status

OTC

2018
16 Apr
OTC Application: 210088

Drug Name

LORATADINE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2018-04-16

210088 / 1

Active Ingredient

LORATADINE

Application Number

210088

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2018-04-16

Regulatory Status

OTC

2025
25 Apr
OTC Application: 210088

Drug Name

LORATADINE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2025-04-25

210088 / 2

Active Ingredient

LORATADINE

Application Number

210088

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2025-04-25

Regulatory Status

OTC

2004
22 Sep
OTC Application: 76557

Drug Name

LORATADINE AND PSEUDOEPHEDRINE SULFATE

Product Number

1

Dosage Form

-

Strength

10MG;240MG

Approval Date

2004-09-22

76557 / 1

Active Ingredient

LORATADINE; PSEUDOEPHEDRINE SULFATE

Application Number

76557

Product Number

1

Dosage Form

-

Strength

10MG;240MG

Approval Date

2004-09-22

Regulatory Status

OTC

2007
11 Apr
OTC Application: 77153

Drug Name

LORATADINE REDIDOSE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2007-04-11

77153 / 1

Active Ingredient

LORATADINE

Application Number

77153

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2007-04-11

Regulatory Status

OTC

2018
12 Oct
OTC Application: 207891

Drug Name

OMEPRAZOLE

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2018-10-12

207891 / 1

Active Ingredient

OMEPRAZOLE

Application Number

207891

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2018-10-12

Regulatory Status

OTC

2014
11 Sep
OTC Application: 202635

Drug Name

OPCICON ONE-STEP

Product Number

1

Dosage Form

-

Strength

1.5MG

Approval Date

2014-09-11

202635 / 1

Active Ingredient

LEVONORGESTREL

Application Number

202635

Product Number

1

Dosage Form

-

Strength

1.5MG

Approval Date

2014-09-11

Regulatory Status

OTC

2005
28 Sep
OTC Application: 77442

Drug Name

PSEUDOEPHEDRINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

120MG

Approval Date

2005-09-28

77442 / 1

Active Ingredient

PSEUDOEPHEDRINE HYDROCHLORIDE

Application Number

77442

Product Number

1

Dosage Form

-

Strength

120MG

Approval Date

2005-09-28

Regulatory Status

OTC

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Drug Status Breakdown
21 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

CETIRIZINE HYDROCHLORIDE ALLERGY

Application Number

77498

Product Number

1

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Dosage Form

-

Strength

5MG

FDA Approved Drug Data

Approved drug product information

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