APPLICATION
ANDA078692
TYPE
ANDA
ORIGINAL APPROVAL
2008-02-14
LATEST ACTION
2025-08-01
ROUTE
ORAL
DOSAGE FORM
TABLET, CHEWABLE
MARKETING STATUS
Over-the-counter
Products
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGYOver-the-counter
CETIRIZINE HYDROCHLORIDE 10MG · TABLET, CHEWABLE · ORAL
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGYOver-the-counter
CETIRIZINE HYDROCHLORIDE 5MG · TABLET, CHEWABLE · ORAL
Approval history
2025-08-01Labeling · Supplement 16 · standardAP
2008-02-14OriginalAP
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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