SEATTLE GENETICS Application 213411

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TUKYSA	TUCATINIB	TABLET;ORAL	50MG	Yes	No
002	TUKYSA	TUCATINIB	TABLET;ORAL	150MG	Yes	Yes

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51144-001	TUKYSA	tucatinib	SEAGEN INC.	NDA	Current
51144-001	TUKYSA	tucatinib	SEAGEN INC.	NDA	Current
51144-001	TUKYSA	tucatinib	Seattle Genetics, Inc.	NDA	Current
51144-002	TUKYSA	tucatinib	SEAGEN INC.	NDA	Current
51144-002	TUKYSA	tucatinib	SEAGEN INC.	NDA	Current
51144-002	TUKYSA	tucatinib	Seattle Genetics, Inc.	NDA	Current