ALEXION PHARM Application 125561

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	KANUMA	SEBELIPASE ALFA	INJECTABLE;INJECTION	20MG/10ML	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
25682-007	KANUMA	Sebelipase alfa	Alexion Pharmaceuticals, Inc.	BLA	Current
25682-007	KANUMA	Sebelipase alfa	Alexion Pharmaceuticals, Inc.	BLA	Current
25682-007	KANUMA	Sebelipase alfa	Alexion Pharmaceuticals, Inc.	BLA	Current
25682-007	KANUMA	Sebelipase alfa	Alexion Pharmaceuticals, Inc.	BLA	Current