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CETIRIZINE HYDROCHLORIDE HIVES

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

Drug application

FDA Application #

ANDA076677

Application type

Abbreviated New Drug Application (Generic)

Brand name

CETIRIZINE HYDROCHLORIDE HIVES

Generic name

CETIRIZINE HYDROCHLORIDE

Active ingredients

CETIRIZINE HYDROCHLORIDE

Dosage form

TABLET

Route

ORAL

Marketing status

Over-the-counter

Sponsor

MYLAN

Manufacturer

Mylan Pharmaceuticals Inc.

First approval

2007-12-27

Source

Authoritative

Drugs@FDA application overview

Machine

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