Application 203756

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	COMETRIQ	CABOZANTINIB S-MALATE	CAPSULE;ORAL	EQ 20MG BASE	Yes	Yes
002	COMETRIQ	CABOZANTINIB S-MALATE	CAPSULE;ORAL	EQ 80MG BASE	Yes	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42388-011	COMETRIQ	cabozantinib	Exelixis, Inc.	NDA	Current
42388-011	COMETRIQ	cabozantinib	Exelixis, Inc.	NDA	Current
42388-011	COMETRIQ	cabozantinib	Exelixis, Inc.	NDA	Current
42388-011	COMETRIQ	cabozantinib	Exelixis, Inc.	NDA	Current
42388-012	COMETRIQ	cabozantinib	Exelixis, Inc.	NDA	Current
42388-012	COMETRIQ	cabozantinib	Exelixis, Inc.	NDA	Current
42388-012	COMETRIQ	cabozantinib	Exelixis, Inc.	NDA	Current
42388-012	COMETRIQ	cabozantinib	Exelixis, Inc.	NDA	Current
42388-013	COMETRIQ	cabozantinib	Exelixis, Inc.	NDA	Current
42388-013	COMETRIQ	cabozantinib	Exelixis, Inc.	NDA	Current
42388-013	COMETRIQ	cabozantinib	Exelixis, Inc.	NDA	Current
42388-013	COMETRIQ	cabozantinib	Exelixis, Inc.	NDA	Current