Application 201275

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SUNITINIB MALATE	SUNITINIB MALATE	CAPSULE;ORAL	EQ 12.5MG BASE	No	No
002	SUNITINIB MALATE	SUNITINIB MALATE	CAPSULE;ORAL	EQ 25MG BASE	No	No
003	SUNITINIB MALATE	SUNITINIB MALATE	CAPSULE;ORAL	EQ 37.5MG BASE	No	No
004	SUNITINIB MALATE	SUNITINIB MALATE	CAPSULE;ORAL	EQ 50MG BASE	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-6678	Sunitinib Malate	sunitinib malate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6678	Sunitinib Malate	sunitinib malate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6679	Sunitinib Malate	sunitinib malate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6679	Sunitinib Malate	sunitinib malate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6680	Sunitinib Malate	sunitinib malate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6680	Sunitinib Malate	sunitinib malate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6681	Sunitinib Malate	sunitinib malate	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6681	Sunitinib Malate	sunitinib malate	Mylan Pharmaceuticals Inc.	ANDA	Current

Document, Submission type, Date table
Document	Submission type	Date
40054	ORIG	2014-02-14
9869	ORIG	2014-02-04