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FDA ANDA · ANDA090572

CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY

Sponsor: TRIS PHARMA INC

APPLICATION
ANDA090572
TYPE
ANDA
ORIGINAL APPROVAL
2012-11-16
LATEST ACTION
2012-11-16
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGYDiscontinued
CETIRIZINE HYDROCHLORIDE 5MG/5ML · SOLUTION · ORAL
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEFDiscontinued
CETIRIZINE HYDROCHLORIDE 5MG/5ML · SOLUTION · ORAL

Approval history

2012-11-16OriginalAP
VIEW ON DRUGS@FDA ↗

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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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