LUPIN LTD Application 211972

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZILEUTON	ZILEUTON	TABLET, EXTENDED RELEASE;ORAL	600MG	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68180-169	ZILEUTON	Zileuton	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-169	ZILEUTON	Zileuton	Lupin Pharmaceuticals, Inc.	ANDA	Current