APPLICATION
ANDA091567
TYPE
ANDA
ORIGINAL APPROVAL
2012-02-06
LATEST ACTION
2015-02-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Over-the-counter, Discontinued
Products
FEXOFENADINE HYDROCHLORIDE ALLERGYOver-the-counter
FEXOFENADINE HYDROCHLORIDE 180MG · TABLET · ORAL
FEXOFENADINE HYDROCHLORIDE ALLERGYDiscontinued
FEXOFENADINE HYDROCHLORIDE 60MG · TABLET · ORAL
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGYDiscontinued
FEXOFENADINE HYDROCHLORIDE 30MG · TABLET · ORAL
FEXOFENADINE HYDROCHLORIDE HIVESOver-the-counter
FEXOFENADINE HYDROCHLORIDE 180MG · TABLET · ORAL
FEXOFENADINE HYDROCHLORIDE HIVESDiscontinued
FEXOFENADINE HYDROCHLORIDE 60MG · TABLET · ORAL
CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVESDiscontinued
FEXOFENADINE HYDROCHLORIDE 30MG · TABLET · ORAL
Approval history
2015-02-25Manufacturing (CMC) · Supplement 1 · unknownAP
2012-02-06OriginalAP
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.