APPLICATION
ANDA076502
TYPE
ANDA
ORIGINAL APPROVAL
2006-04-11
LATEST ACTION
2013-01-02
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued, Over-the-counter
Products
FEXOFENADINE HYDROCHLORIDEDiscontinued
FEXOFENADINE HYDROCHLORIDE 180MG · TABLET · ORAL
FEXOFENADINE HYDROCHLORIDEDiscontinued
FEXOFENADINE HYDROCHLORIDE 30MG · TABLET · ORAL
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 HYDROCHLORIDEDiscontinued
FEXOFENADINE HYDROCHLORIDE 60MG · 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
2013-01-02Manufacturing (CMC) · Supplement 9AP
2011-09-23Manufacturing (CMC) · Supplement 8AP
2011-04-12Manufacturing (CMC) · Supplement 7AP
2009-01-14Labeling · Supplement 2AP
2006-04-11OriginalAP
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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