Application 212670

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
49884-723	Zileuton	zileuton	Par Pharmaceutical, Inc.	ANDA	Current
49884-723	Zileuton	zileuton	Par Pharmaceutical, Inc.	ANDA	Current
64380-189	Zileuton	zileuton	Strides Pharma Science Limited	ANDA	Current