Application 210315

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BACLOFEN	BACLOFEN	INJECTABLE;INTRATHECAL	1MG/ML	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
25021-680	Baclofen	Baclofen	Sagent Pharmaceuticals	ANDA	Current
70511-123	Baclofen	Baclofen	MAlA Pharmaceuticals, Inc.	ANDA	Current
70511-123	Baclofen	Baclofen	MAlA Pharmaceuticals, Inc.	ANDA	Current