APPLICATION
ANDA077829
TYPE
ANDA
ORIGINAL APPROVAL
2009-08-26
LATEST ACTION
2025-03-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Over-the-counter
Products
CETIRIZINE HYDROCHLORIDE HIVESOver-the-counter
CETIRIZINE HYDROCHLORIDE 5MG · TABLET · ORAL
CETIRIZINE HYDROCHLORIDE ALLERGYOver-the-counter
CETIRIZINE HYDROCHLORIDE 5MG · TABLET · ORAL
CETIRIZINE HYDROCHLORIDE ALLERGYOver-the-counter
CETIRIZINE HYDROCHLORIDE 10MG · TABLET · ORAL
CETIRIZINE HYDROCHLORIDE HIVESOver-the-counter
CETIRIZINE HYDROCHLORIDE 10MG · TABLET · ORAL
Approval history
2025-03-13Manufacturing (CMC) · Supplement 19 · unknownAP
2016-01-26Labeling · Supplement 5 · standardAP
2013-09-09Manufacturing (CMC) · Supplement 1AP
2009-08-26OriginalAP
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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