Application 021454

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TESTIM	TESTOSTERONE	GEL;TRANSDERMAL	50MG/5GM PACKET	Yes	Yes

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0254-1012	Testosterone	testosterone	Par Pharmaceutical, Inc.	NDA AUTHORIZED GENERIC	Current
0254-1012	Testosterone	testosterone	Par Pharmaceutical, Inc.	NDA AUTHORIZED GENERIC	Current
0254-1012	Testosterone	testosterone	Par Pharmaceutical, Inc.	NDA AUTHORIZED GENERIC	Current
66887-001	Testim	testosterone	Endo Pharmaceuticals Inc.	NDA	Current
66887-001	Testim	testosterone	Endo Pharmaceuticals, Inc.	NDA	Current
66887-001	Testim	testosterone	Endo Pharmaceuticals, Inc.	NDA	Current
66887-001	Testim	testosterone	Endo Pharmaceuticals Inc.	NDA	Current