EMD SERONO Application 021149

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OVIDREL	CHORIOGONADOTROPIN ALFA	INJECTABLE;INJECTION	0.25MG/VIAL	No	No
002	OVIDREL	CHORIOGONADOTROPIN ALFA	INJECTABLE;SUBCUTANEOUS	EQ 0.25MG /0.5ML	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
44087-1150	Ovidrel	choriogonadotropin alfa	EMD Serono, Inc.	BLA	Current
44087-1150	Ovidrel	choriogonadotropin alfa	EMD Serono, Inc.	BLA	Current
44087-1150	Ovidrel	choriogonadotropin alfa	EMD Serono, Inc.	NDA	Current