APPLICATION
ANDA077498
TYPE
ANDA
ORIGINAL APPROVAL
2007-12-27
LATEST ACTION
2011-02-15
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 HIVESOver-the-counter
CETIRIZINE HYDROCHLORIDE 10MG · TABLET · ORAL
CETIRIZINE HYDROCHLORIDE ALLERGYOver-the-counter
CETIRIZINE HYDROCHLORIDE 10MG · TABLET · ORAL
Approval history
2011-02-15Labeling · Supplement 5AP
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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