Granules India Limited OTC
FDA Approved Drugs

Granules India 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 12
  • Latest Approval Date Feb 23, 2021
  • Data Source FDA
  • First Approval Date Dec 10, 2010
All
83
View
Unclassified
2
View
Discontinued
21
View
OTC
12
View
RX
48
View
Company Overview

Company

Granules India Limited OTC

Country

India

Website

Visit Website

Email

mail@granulesindia.com

Social Profiles

LinkedIn X / Twitter
Company Snapshot

Granules India Limited OTC

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 ( 12 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

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

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

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

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

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

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

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Drug Status Breakdown
12 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

211544

Product Number

1

Active Ingredient

ACETAMINOPHEN

Dosage Form

-

Strength

650MG

FDA Approved Drug Data

Approved drug product information

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