AMGEN INC Application 214665

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LUMAKRAS	SOTORASIB	TABLET;ORAL	120MG	No	No
002	LUMAKRAS	SOTORASIB	TABLET;ORAL	320MG	Yes	Yes
003	LUMAKRAS	SOTORASIB	TABLET;ORAL	240MG	Yes	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
55513-488	LUMAKRAS	sotorasib	Amgen Inc	NDA	Current
55513-488	LUMAKRAS	sotorasib	Amgen Inc	NDA	Current
55513-488	LUMAKRAS	sotorasib	Amgen Inc	NDA	Current
55513-488	LUMAKRAS	sotorasib	Amgen Inc	NDA	Current