Amneal Pharmaceuticals OTC
FDA Approved Drugs

Amneal Pharmaceuticals 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 3
  • Latest Approval Date Mar 18, 2016
  • Data Source FDA
  • First Approval Date Oct 07, 2009
All
120
View
Discontinued
21
View
OTC
3
View
RX
96
View
Company Overview

Company

Amneal Pharmaceuticals OTC

Country

U.S.A

Social Profiles

Company Snapshot

Amneal Pharmaceuticals OTC

400 Crossing Boulevard, 3rd Floor Bridgewater, New Jersey 08807

U.S.A

amneal.com/ nfo@rakspharma.com View on Map
FDA Approved Drug Records ( 3 records )
2009
07 Oct
OTC Application: 90765

Drug Name

CHILDRENS CETIRIZINE HYDROCHLORIDE ALLERGY

Product Number

2

Dosage Form

-

Strength

5MG/5ML

Approval Date

2009-10-07

90765 / 2

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

90765

Product Number

2

Dosage Form

-

Strength

5MG/5ML

Approval Date

2009-10-07

Regulatory Status

OTC

2009
07 Oct
OTC Application: 90765

Drug Name

CHILDRENS CETIRIZINE HYDROCHLORIDE HIVES RELIEF

Product Number

1

Dosage Form

-

Strength

5MG/5ML

Approval Date

2009-10-07

90765 / 1

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

90765

Product Number

1

Dosage Form

-

Strength

5MG/5ML

Approval Date

2009-10-07

Regulatory Status

OTC

2016
18 Mar
OTC Application: 208077

Drug Name

DICLOFENAC SODIUM

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

2016-03-18

208077 / 1

Active Ingredient

DICLOFENAC SODIUM

Application Number

208077

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

2016-03-18

Regulatory Status

OTC

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Drug Status Breakdown
3 total
  • OTC
Official Source

FDA approved drug data is based on publicly available U.S. Food and Drug Administration Orange Book information.

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FDA Approved Drug Record Details Preview

Explore important FDA approved drug information available in the records above.

Drug Name

CHILDRENS CETIRIZINE HYDROCHLORIDE ALLERGY

Application Number

90765

Product Number

2

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Dosage Form

-

Strength

5MG/5ML

FDA Approved Drug Data

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