APPLICATION
ANDA078680
TYPE
ANDA
ORIGINAL APPROVAL
2009-06-26
LATEST ACTION
2020-03-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
CETIRIZINE HYDROCHLORIDE ALLERGYDiscontinued
CETIRIZINE HYDROCHLORIDE 5MG · TABLET · ORAL
CETIRIZINE HYDROCHLORIDE HIVESDiscontinued
CETIRIZINE HYDROCHLORIDE 5MG · TABLET · ORAL
CETIRIZINE HYDROCHLORIDE ALLERGYDiscontinued
CETIRIZINE HYDROCHLORIDE 10MG · TABLET · ORAL
CETIRIZINE HYDROCHLORIDE HIVESDiscontinued
CETIRIZINE HYDROCHLORIDE 10MG · TABLET · ORAL
Approval history
2020-03-03Labeling · Supplement 8 · standardAP
2010-07-23Manufacturing (CMC) · Supplement 1AP
2009-06-26OriginalAP
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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