Application 201676

Related Records

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SIROLIMUS	SIROLIMUS	TABLET; ORAL	0.5MG	No	No
002	SIROLIMUS	SIROLIMUS	TABLET; ORAL	1MG	No	No
003	SIROLIMUS	SIROLIMUS	TABLET;ORAL	0.5MG	No	No

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
65841-771	sirolimus	sirolimus	Zydus Lifesciences Limited	ANDA	Current
65841-771	sirolimus	sirolimus	Cadila Healthcare Limited	ANDA	Current
65841-771	sirolimus	sirolimus	Cadila Healthcare Limited	ANDA	Current
65841-771	sirolimus	sirolimus	Cadila Healthcare Limited	ANDA	Current
68084-956	Sirolimus	Sirolimus	American Health Packaging	ANDA	Current
68084-956	Sirolimus	Sirolimus	American Health Packaging	ANDA	Current
68382-520	sirolimus	sirolimus	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-520	sirolimus	sirolimus	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-520	sirolimus	sirolimus	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-520	sirolimus	sirolimus	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-520	sirolimus	sirolimus	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current