REGENERON PHARMACEUTICALS Application 761181

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	EVKEEZA	EVINACUMAB-DGNB	SOLUTION; INJECTION	345MG/2.3ML	No	No
002	EVKEEZA	EVINACUMAB-DGNB	SOLUTION; INJECTION	1200MG/8ML	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
61755-010	Evkeeza	evinacumab	Regeneron Pharmaceuticals, Inc.	BLA	Current
61755-010	Evkeeza	evinacumab	Regeneron Pharmaceuticals, Inc.	BLA	Current
61755-013	Evkeeza	evinacumab	Regeneron Pharmaceuticals, Inc.	BLA	Current
61755-013	Evkeeza	evinacumab	Regeneron Pharmaceuticals, Inc.	BLA	Current