Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077081
Company: RISING

Products on ANDA 077081

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET;ORAL	Discontinued	None	No	No
CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET;ORAL	Discontinued	None	No	No
FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET;ORAL	Discontinued	None	No	No
FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	30MG	TABLET;ORAL	Discontinued	None	No	No
FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET;ORAL	Discontinued	None	No	No
FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET;ORAL	Discontinued	None	No	No
FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET;ORAL	Discontinued	None	No	No
FEXOFENADINE HYDROCHLORIDE HIVES	FEXOFENADINE HYDROCHLORIDE	60MG	TABLET;ORAL	Discontinued	None	No	No
FEXOFENADINE HYDROCHLORIDE HIVES	FEXOFENADINE HYDROCHLORIDE	180MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077081

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/16/2007	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/31/2019	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
07/21/2011	SUPPL-12	Labeling-Container/Carton Labels		Label is not available on this site.
05/15/2010	SUPPL-10	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
04/11/2008	SUPPL-4	Labeling		Label is not available on this site.