Application 212453

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LEFLUNOMIDE	LEFLUNOMIDE	TABLET;ORAL	10MG	No	No
002	LEFLUNOMIDE	LEFLUNOMIDE	TABLET;ORAL	20MG	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10702-277	Leflunomide	Leflunomide	KVK-Tech, Inc.	ANDA	Current
10702-278	Leflunomide	Leflunomide	KVK-Tech, Inc.	ANDA	Current
70518-3240	Leflunomide	Leflunomide	REMEDYREPACK INC.	ANDA	Current