Application 022575

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VPRIV	VELAGLUCERASE ALFA	INJECTABLE;INTRAVENOUS	400 UNITS/VIAL	No	No
002	VPRIV	VELAGLUCERASE ALFA	POWDER;INTRAVENOUS	200 UNITS/VIAL	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
54092-701	VPRIV	velaglucerase alfa	Shire US Manufacturing Inc.	BLA	Current
54092-701	VPRIV	velaglucerase alfa	Takeda Pharmaceuticals America, Inc.	BLA	Current
54092-701	VPRIV	velaglucerase alfa	Takeda Pharmaceuticals America, Inc.	BLA	Current
54092-701	VPRIV	velaglucerase alfa	Takeda Pharmaceuticals America, Inc.	BLA	Current
54092-701	VPRIV	velaglucerase alfa	Takeda Pharmaceuticals America, Inc.	BLA	Current
54092-701	VPRIV	velaglucerase alfa	Takeda Pharmaceuticals America, Inc.	BLA	Current
54092-701	VPRIV	velaglucerase alfa	Shire US Manufacturing Inc.	NDA	Current
54092-701	VPRIV	velaglucerase alfa	Shire US Manufacturing Inc.	NDA	Current
54092-701	VPRIV	velaglucerase alfa	Shire US Manufacturing Inc.	NDA	Current