NOVEN Application 077775

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FENTANYL-25	FENTANYL	FILM, EXTENDED RELEASE;TRANSDERMAL	25MCG/HR	No	No
002	FENTANYL-50	FENTANYL	FILM, EXTENDED RELEASE;TRANSDERMAL	50MCG/HR	No	No
003	FENTANYL-75	FENTANYL	FILM, EXTENDED RELEASE;TRANSDERMAL	75MCG/HR	No	No
004	FENTANYL-100	FENTANYL	FILM, EXTENDED RELEASE;TRANSDERMAL	100MCG/HR	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
52959-585	Fentanyl	fentanyl	H.J. Harkins Company, Inc.	ANDA	Current
52959-658	Fentanyl	Fentanyl	H.J. Harkins Company, Inc.	ANDA	Current

Document, Submission type, Date table
Document	Submission type	Date
44537	ORIG	2015-03-24