Application 077081

Type: ANDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	TABLET;ORAL	180MG	No	No
002	FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	TABLET;ORAL	30MG	No	No
003	FEXOFENADINE HYDROCHLORIDE	FEXOFENADINE HYDROCHLORIDE	TABLET;ORAL	60MG	No	No
004	CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	TABLET;ORAL	30MG	No	No
005	CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	FEXOFENADINE HYDROCHLORIDE	TABLET;ORAL	30MG	No	No
006	FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	TABLET;ORAL	60MG	No	No
007	FEXOFENADINE HYDROCHLORIDE HIVES	FEXOFENADINE HYDROCHLORIDE	TABLET;ORAL	60MG	No	No
008	FEXOFENADINE HYDROCHLORIDE ALLERGY	FEXOFENADINE HYDROCHLORIDE	TABLET;ORAL	180MG	No	No
009	FEXOFENADINE HYDROCHLORIDE HIVES	FEXOFENADINE HYDROCHLORIDE	TABLET;ORAL	180MG	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-0781	Fexofenadine Hydrochloride	fexofenadine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0781	Fexofenadine Hydrochloride	fexofenadine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0781	Fexofenadine Hydrochloride	fexofenadine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0781	Fexofenadine Hydrochloride	fexofenadine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0781	Fexofenadine Hydrochloride	fexofenadine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0782	Fexofenadine Hydrochloride	fexofenadine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0782	Fexofenadine Hydrochloride	fexofenadine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0782	Fexofenadine Hydrochloride	fexofenadine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0782	Fexofenadine Hydrochloride	fexofenadine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0782	Fexofenadine Hydrochloride	fexofenadine	Mylan Pharmaceuticals Inc.	ANDA	Current
43353-760	Fexofenadine Hydrochloride	fexofenadine	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
51079-547	Fexofenadine Hydrochloride	fexofenadine hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-547	Fexofenadine Hydrochloride	fexofenadine hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-548	Fexofenadine Hydrochloride	fexofenadine hydrochloride	Mylan Institutional Inc.	ANDA	Current
51079-548	Fexofenadine Hydrochloride	fexofenadine hydrochloride	Mylan Institutional Inc.	ANDA	Current
70518-0746	Fexofenadine Hydrochloride	fexofenadine	REMEDYREPACK INC.	ANDA	Current
70518-0746	Fexofenadine Hydrochloride	fexofenadine	REMEDYREPACK INC.	ANDA	Current