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CETIRIZINE HYDROCHLORIDE ALLERGY

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: APOTEX INC · Approved 2007-12-27

Drug application

FDA Application #

ANDA078317

Application type

Abbreviated New Drug Application (Generic)

Brand name

CETIRIZINE HYDROCHLORIDE ALLERGY

Generic name

CETIRIZINE HCL 10 MG

Active ingredients

CETIRIZINE HYDROCHLORIDE

Dosage form

TABLET

Route

ORAL

Marketing status

Over-the-counter

Sponsor

APOTEX INC

Manufacturer

Allegiant Health

First approval

2007-12-27

Source

Authoritative

Drugs@FDA application overview

Machine

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