Application 212936

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	EVEROLIMUS	EVEROLIMUS	TABLET;ORAL	2.5MG	No	No
002	EVEROLIMUS	EVEROLIMUS	TABLET;ORAL	5MG	No	No
003	EVEROLIMUS	EVEROLIMUS	TABLET;ORAL	7.5MG	No	No
004	EVEROLIMUS	EVEROLIMUS	TABLET;ORAL	10MG	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-3096	everolimus	everolimus	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3096	everolimus	everolimus	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3096	everolimus	everolimus	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3096	everolimus	everolimus	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3097	everolimus	everolimus	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3097	everolimus	everolimus	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3097	everolimus	everolimus	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3097	everolimus	everolimus	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3098	everolimus	everolimus	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3098	everolimus	everolimus	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3098	everolimus	everolimus	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3098	everolimus	everolimus	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3099	everolimus	everolimus	Mylan Pharmaceuticals Inc.	ANDA	Current