Application 212669

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEFERASIROX	DEFERASIROX	TABLET;ORAL	90MG	No	No
002	DEFERASIROX	DEFERASIROX	TABLET;ORAL	180MG	No	No
003	DEFERASIROX	DEFERASIROX	TABLET;ORAL	360MG	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
72606-013	Deferasirox	Deferasirox	CELLTRION USA, INC.	ANDA	Current
72606-014	Deferasirox	Deferasirox	CELLTRION USA, INC.	ANDA	Current
72606-015	Deferasirox	Deferasirox	CELLTRION USA, INC.	ANDA	Current