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FDA ANDA · ANDA090474

CETRIZINE HYDROCHLORIDE

cetirizine hydrochloride

Sponsor: APOZEAL PHARMS

APPLICATION
ANDA090474
TYPE
ANDA
ORIGINAL APPROVAL
2009-03-30
LATEST ACTION
2009-03-30
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Over-the-counter

Products

CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGYOver-the-counter
CETIRIZINE HYDROCHLORIDE 5MG/5ML · SOLUTION · ORAL
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEFOver-the-counter
CETIRIZINE HYDROCHLORIDE 5MG/5ML · SOLUTION · ORAL

Approval history

2009-03-30OriginalAP
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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