Application 210050

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
0093-7766	Everolimus	Everolimus	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7766	Everolimus	Everolimus	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7766	Everolimus	Everolimus	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7766	Everolimus	Everolimus	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7766	Everolimus	Everolimus	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7766	Everolimus	Everolimus	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7767	Everolimus	Everolimus	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7767	Everolimus	Everolimus	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7767	Everolimus	Everolimus	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7767	Everolimus	Everolimus	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7767	Everolimus	Everolimus	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7767	Everolimus	Everolimus	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7768	Everolimus	Everolimus	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7768	Everolimus	Everolimus	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7768	Everolimus	Everolimus	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7768	Everolimus	Everolimus	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7768	Everolimus	Everolimus	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7768	Everolimus	Everolimus	Teva Pharmaceuticals USA, Inc.	ANDA	Current

Document, Submission type, Date table
Document	Submission type	Date
62238	ORIG	2020-03-23