APPLICATION
ANDA076447
TYPE
ANDA
ORIGINAL APPROVAL
2005-09-01
LATEST ACTION
2019-10-31
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued, Over-the-counter
Products
FEXOFENADINE HYDROCHLORIDE ALLERGYDiscontinued
FEXOFENADINE HYDROCHLORIDE 180MG · TABLET · ORAL
FEXOFENADINE HYDROCHLORIDE ALLERGYDiscontinued
FEXOFENADINE HYDROCHLORIDE 60MG · TABLET · ORAL
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGYDiscontinued
FEXOFENADINE HYDROCHLORIDE 30MG · TABLET · ORAL
FEXOFENADINE HYDROCHLORIDEDiscontinued
FEXOFENADINE HYDROCHLORIDE 60MG · 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
FEXOFENADINE HYDROCHLORIDEDiscontinued
FEXOFENADINE HYDROCHLORIDE 180MG · TABLET · ORAL
FEXOFENADINE HYDROCHLORIDEDiscontinued
FEXOFENADINE HYDROCHLORIDE 30MG · TABLET · ORAL
Approval history
2019-10-31Labeling · Supplement 26 · standardAP
2013-09-04Manufacturing (CMC) · Supplement 17AP
2012-12-20Labeling · Supplement 20AP
2011-04-13Manufacturing (CMC) · Supplement 18AP
2009-03-19Labeling · Supplement 10AP
2007-01-25Labeling · Supplement 6AP
2006-07-07Labeling · Supplement 4AP
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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