CHIESI Application 020471

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZYFLO	ZILEUTON	TABLET;ORAL	300MG	No	No
003	ZYFLO	ZILEUTON	TABLET;ORAL	600MG	Yes	Yes

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10122-901	ZYFLO	zileuton	Chiesi USA, Inc.	NDA	Current
10122-901	ZYFLO	zileuton	Chiesi USA, Inc.	NDA	Current
10122-901	ZYFLO	zileuton	Chiesi USA, Inc.	NDA	Current
10122-901	ZYFLO	zileuton	Chiesi USA, Inc.	NDA	Current