← FDA DRUG APPROVALS
FDA ANDA · ANDA077631
CETIRIZINE HYDROCHLORIDE ALLERGY
Sponsor: SUN PHARM INDS INC
APPLICATION
ANDA077631
TYPE
ANDA
ORIGINAL APPROVAL
2008-01-11
LATEST ACTION
2008-01-11
ROUTE
ORAL
DOSAGE FORM
TABLET, CHEWABLE
MARKETING STATUS
Discontinued
Products
CETIRIZINE HYDROCHLORIDE ALLERGYDiscontinued
CETIRIZINE HYDROCHLORIDE 5MG · TABLET, CHEWABLE · ORAL
CETIRIZINE HYDROCHLORIDE HIVES RELIEFDiscontinued
CETIRIZINE HYDROCHLORIDE 10MG · TABLET, CHEWABLE · ORAL
CETIRIZINE HYDROCHLORIDE ALLERGYDiscontinued
CETIRIZINE HYDROCHLORIDE 10MG · TABLET, CHEWABLE · ORAL
CETIRIZINE HYDROCHLORIDE HIVES RELIEFDiscontinued
CETIRIZINE HYDROCHLORIDE 5MG · TABLET, CHEWABLE · ORAL
Approval history
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.