BIOMARIN Application 125058

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ALDURAZYME	LARONIDASE	VIAL	2.9MG/ML	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
58468-0070	ALDURAZYME	laronidase	Genzyme Corporation	BLA	Current
58468-0070	ALDURAZYME	laronidase	Genzyme Corporation	BLA	Current
58468-0070	ALDURAZYME	laronidase	Genzyme Corporation	BLA	Current
58468-0070	ALDURAZYME	laronidase	Genzyme Corporation	BLA	Current