Application 206133

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	EVEROLIMUS	EVEROLIMUS	TABLET;ORAL	0.25MG	No	No
002	EVEROLIMUS	EVEROLIMUS	TABLET;ORAL	0.5MG	No	No
003	EVEROLIMUS	EVEROLIMUS	TABLET;ORAL	0.75MG	No	No
004	EVEROLIMUS	EVEROLIMUS	TABLET;ORAL	1MG	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0054-0470	Everolimus	Everolimus	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0470	Everolimus	Everolimus	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-0470	Everolimus	Everolimus	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0471	Everolimus	Everolimus	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0471	Everolimus	Everolimus	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-0471	Everolimus	Everolimus	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0472	Everolimus	Everolimus	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0472	Everolimus	Everolimus	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-0472	Everolimus	Everolimus	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0604	Everolimus	Everolimus	Hikma Pharmaceuticals USA Inc.	ANDA	Current

Document, Submission type, Date table
Document	Submission type	Date
54148	ORIG	2018-05-11