Application 208692

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CABOMETYX	CABOZANTINIB S-MALATE	TABLET;ORAL	EQ 20MG BASE	Yes	No
002	CABOMETYX	CABOZANTINIB S-MALATE	TABLET;ORAL	EQ 40MG BASE	Yes	No
003	CABOMETYX	CABOZANTINIB S-MALATE	TABLET;ORAL	EQ 60MG BASE	Yes	Yes

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42388-023	CABOMETYX	cabozantinib	Exelixis, Inc.	NDA	Current
42388-023	CABOMETYX	cabozantinib	Exelixis, Inc.	NDA	Current
42388-023	CABOMETYX	cabozantinib	Exelixis, Inc.	NDA	Current
42388-023	CABOMETYX	cabozantinib	Exelixis, Inc.	NDA	Current
42388-023	CABOMETYX	cabozantinib	Exelixis, Inc.	NDA	Current
42388-023	CABOMETYX	cabozantinib	Exelixis, Inc.	NDA	Current
42388-023	CABOMETYX	cabozantinib	Exelixis, Inc.	NDA	Current
42388-024	CABOMETYX	cabozantinib	Exelixis, Inc.	NDA	Current
42388-024	CABOMETYX	cabozantinib	Exelixis, Inc.	NDA	Current
42388-024	CABOMETYX	cabozantinib	Exelixis, Inc.	NDA	Current
42388-024	CABOMETYX	cabozantinib	Exelixis, Inc.	NDA	Current
42388-024	CABOMETYX	cabozantinib	Exelixis, Inc.	NDA	Current
42388-024	CABOMETYX	cabozantinib	Exelixis, Inc.	NDA	Current
42388-024	CABOMETYX	cabozantinib	Exelixis, Inc.	NDA	Current
42388-025	CABOMETYX	cabozantinib	Exelixis, Inc.	NDA	Current
42388-025	CABOMETYX	cabozantinib	Exelixis, Inc.	NDA	Current
42388-025	CABOMETYX	cabozantinib	Exelixis, Inc.	NDA	Current
42388-025	CABOMETYX	cabozantinib	Exelixis, Inc.	NDA	Current
42388-025	CABOMETYX	cabozantinib	Exelixis, Inc.	NDA	Current
42388-025	CABOMETYX	cabozantinib	Exelixis, Inc.	NDA	Current
42388-025	CABOMETYX	cabozantinib	Exelixis, Inc.	NDA	Current