Application 090642

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VALSARTAN	VALSARTAN	TABLET;ORAL	40MG	No	No
002	VALSARTAN	VALSARTAN	TABLET;ORAL	80MG	No	No
003	VALSARTAN	VALSARTAN	TABLET;ORAL	160MG	No	No
004	VALSARTAN	VALSARTAN	TABLET;ORAL	320MG	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0591-2167	Valsartan	valsartan	Actavis Pharma, Inc.	ANDA	Current
0591-2168	Valsartan	valsartan	Actavis Pharma, Inc.	ANDA	Current
0591-2169	Valsartan	valsartan	Actavis Pharma, Inc.	ANDA	Current
0591-2170	Valsartan	valsartan	Actavis Pharma, Inc.	ANDA	Current
0904-6594	Valsartan	valsartan	Major Pharmaceuticals	ANDA	Current
0904-6595	Valsartan	valsartan	Major Pharmaceuticals	ANDA	Current
50436-2168	Valsartan	Valsartan	Unit Dose Services	ANDA	Current
71335-0600	Valsartan	Valsartan	Bryant Ranch Prepack	ANDA	Current