SHIRE Application 125151

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ELAPRASE	IDURSULFASE	INJECTABLE; IV (INFUSION)	6MG/3ML	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
54092-700	ELAPRASE	idursulfase	Takeda Pharmaceuticals America, Inc.	BLA	Current
54092-700	ELAPRASE	idursulfase	Takeda Pharmaceuticals America, Inc.	BLA	Current
54092-700	ELAPRASE	idursulfase	Takeda Pharmaceuticals America, Inc.	BLA	Current
54092-700	ELAPRASE	idursulfase	Shire US Manufacturing Inc.	BLA	Current