Application 213914

Related Records

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	Labeler	Marketing category	Status
16714-676	Sunitinib malate	Sunitinib malate	NorthStar RxLLC	ANDA	Current
16714-677	Sunitinib malate	Sunitinib malate	NorthStar RxLLC	ANDA	Current
16714-678	Sunitinib malate	Sunitinib malate	NorthStar RxLLC	ANDA	Current
16714-679	Sunitinib malate	Sunitinib malate	NorthStar RxLLC	ANDA	Current
63304-091	Sunitinib malate	Sunitinib malate	Sun Pharmaceutical Industries Inc.	ANDA	Current
63304-091	Sunitinib malate	Sunitinib malate	Sun Pharmaceutical Industries Inc.	ANDA	Current
63304-091	Sunitinib malate	Sunitinib malate	Sun Pharmaceutical Industries Inc.	ANDA	Current
63304-092	Sunitinib malate	Sunitinib malate	Sun Pharmaceutical Industries Inc.	ANDA	Current
63304-092	Sunitinib malate	Sunitinib malate	Sun Pharmaceutical Industries Inc.	ANDA	Current
63304-092	Sunitinib malate	Sunitinib malate	Sun Pharmaceutical Industries Inc.	ANDA	Current
63304-093	Sunitinib malate	Sunitinib malate	Sun Pharmaceutical Industries Inc.	ANDA	Current
63304-093	Sunitinib malate	Sunitinib malate	Sun Pharmaceutical Industries Inc.	ANDA	Current
63304-093	Sunitinib malate	Sunitinib malate	Sun Pharmaceutical Industries Inc.	ANDA	Current
63304-094	Sunitinib malate	Sunitinib malate	Sun Pharmaceutical Industries Inc.	ANDA	Current
63304-094	Sunitinib malate	Sunitinib malate	Sun Pharmaceutical Industries Inc.	ANDA	Current
63304-094	Sunitinib malate	Sunitinib malate	Sun Pharmaceutical Industries Inc.	ANDA	Current

Document	Title	Submission type	Submission no.	Date	Storage
68525	0	ORIG	1	2021-09-02	Cached in FDA.report object storage