LOXO ONCOLOGY INC Application 213246

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RETEVMO	SELPERCATINIB	CAPSULE;ORAL	40MG	Yes	No
002	RETEVMO	SELPERCATINIB	CAPSULE;ORAL	80MG	Yes	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0002-2980	RETEVMO	selpercatinib	Eli Lilly and Company	NDA	Current
0002-2980	RETEVMO	selpercatinib	Eli Lilly and Company	NDA	Current
0002-2980	RETEVMO	selpercatinib	Eli Lilly and Company	NDA	Current
0002-2980	RETEVMO	selpercatinib	Eli Lilly and Company	NDA	Current
0002-3977	RETEVMO	selpercatinib	Eli Lilly and Company	NDA	Current
0002-3977	RETEVMO	selpercatinib	Eli Lilly and Company	NDA	Current
0002-3977	RETEVMO	selpercatinib	Eli Lilly and Company	NDA	Current
0002-3977	RETEVMO	selpercatinib	Eli Lilly and Company	NDA	Current