Application 209433

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEFERASIROX	DEFERASIROX	TABLET, FOR SUSPENSION;ORAL	125MG	No	No
002	DEFERASIROX	DEFERASIROX	TABLET, FOR SUSPENSION;ORAL	250MG	No	No
003	DEFERASIROX	DEFERASIROX	TABLET, FOR SUSPENSION;ORAL	500MG	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68462-494	deferasirox	deferasirox	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-494	deferasirox	deferasirox	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-494	deferasirox	deferasirox	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-495	deferasirox	deferasirox	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-495	deferasirox	deferasirox	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-495	deferasirox	deferasirox	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-496	deferasirox	deferasirox	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-496	deferasirox	deferasirox	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-496	deferasirox	deferasirox	Glenmark Pharmaceuticals Inc., USA	ANDA	Current