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FDA ANDA · ANDA078780

CETIRIZINE HYDROCHLORIDE

cetirizine

Sponsor: AMNEAL PHARMS NY

APPLICATION
ANDA078780
TYPE
ANDA
ORIGINAL APPROVAL
2010-01-21
LATEST ACTION
2010-01-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

CETIRIZINE HYDROCHLORIDE ALLERGYDiscontinued
CETIRIZINE HYDROCHLORIDE 10MG · TABLET · ORAL
CETIRIZINE HYDROCHLORIDE HIVES RELIEFDiscontinued
CETIRIZINE HYDROCHLORIDE 10MG · TABLET · ORAL
CETIRIZINE HYDROCHLORIDE HIVES RELIEFDiscontinued
CETIRIZINE HYDROCHLORIDE 5MG · TABLET · ORAL
CETIRIZINE HYDROCHLORIDE ALLERGYDiscontinued
CETIRIZINE HYDROCHLORIDE 5MG · TABLET · ORAL

Approval history

2010-01-21Original — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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