Application 212984

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TESTOSTERONE	TESTOSTERONE	GEL;TRANSDERMAL	50MG/5GM PACKET	No	No
002	TESTOSTERONE	TESTOSTERONE	GEL, METERED;TRANSDERMAL	12.5MG/1.25GM ACTUATION	No	No
003	TESTOSTERONE	TESTOSTERONE	GEL;TRANSDERMAL	25MG/2.5GM PACKET	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
21922-019	Testosterone Gel, 1%	Testosterone Gel, 1%	Encube Ethicals Private Limited	ANDA	Current
21922-019	Testosterone Gel, 1%	Testosterone Gel, 1%	Encube Ethicals Private Limited	ANDA	Current
21922-019	Testosterone Gel, 1%	Testosterone Gel, 1%	Encube Ethicals Private Limited	ANDA	Current
63629-9585	Testosterone Gel, 1%	Testosterone Gel, 1%	Bryant Ranch Prepack	ANDA	Current