APPLICATION
ANDA079112
TYPE
ANDA
ORIGINAL APPROVAL
2012-02-08
LATEST ACTION
2014-11-14
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Over-the-counter
Products
FEXOFENADINE HYDROCHLORIDE ALLERGYOver-the-counter
FEXOFENADINE HYDROCHLORIDE 180MG · TABLET · ORAL
FEXOFENADINE HYDROCHLORIDE ALLERGYOver-the-counter
FEXOFENADINE HYDROCHLORIDE 60MG · TABLET · ORAL
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGYOver-the-counter
FEXOFENADINE HYDROCHLORIDE 30MG · TABLET · ORAL
FEXOFENADINE HYDROCHLORIDE HIVESOver-the-counter
FEXOFENADINE HYDROCHLORIDE 180MG · TABLET · ORAL
FEXOFENADINE HYDROCHLORIDE HIVESOver-the-counter
FEXOFENADINE HYDROCHLORIDE 60MG · TABLET · ORAL
CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVESOver-the-counter
FEXOFENADINE HYDROCHLORIDE 30MG · TABLET · ORAL
Approval history
2014-11-14Manufacturing (CMC) · Supplement 1AP
2012-02-08OriginalAP
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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