Application 761092

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	REVCOVI	ELAPEGADEMASE-LVLR	INJECTABLE;INJECTION	1.6MG/ML	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10122-502	Revcovi	elapegademase-lvlr	Chiesi USA, Inc.	BLA	Current
10122-502	Revcovi	elapegademase-lvlr	Chiesi USA, Inc.	BLA	Current
10122-502	Revcovi	elapegademase-lvlr	Chiesi USA, Inc.	BLA	Current
57665-002	Revcovi	elapegademase-lvlr	Leadiant Biosciences, Inc.	BLA	Current
57665-002	Revcovi	elapegademase-lvlr	Leadiant Biosciences, Inc.	BLA	Current
57665-002	Revcovi	elapegademase-lvlr	Leadiant Biosciences, Inc.	BLA	Current
57665-002	Revcovi	elapegademase-lvlr	Leadiant Biosciences, Inc.	BLA	Current
57665-002	Revcovi	elapegademase-lvlr	Leadiant Biosciences, Inc.	BLA	Current
57665-002	Revcovi	elapegademase-lvlr	Leadiant Biosciences, Inc.	BLA	Current
57665-002	Revcovi	elapegademase-lvlr	Leadiant Biosciences, Inc.	BLA	Current
57665-002	Revcovi	elapegademase-lvlr	Leadiant Biosciences, Inc.	BLA	Current
57665-002	Revcovi	elapegademase-lvlr	Leadiant Biosciences, Inc.	BLA	Current