CHEPLAPHARM Application 019661

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CYTOVENE	GANCICLOVIR SODIUM	INJECTABLE;INJECTION	EQ 500MG BASE/VIAL	Yes	Yes

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0004-6940	Cytovene	ganciclovir sodium	Genentech, Inc.	NDA	Current
0004-6940	Cytovene	ganciclovir sodium	Genentech, Inc.	NDA	Current
61269-450	Cytovene	ganciclovir sodium	H2-Pharma, LLC	NDA	Current
61269-450	Cytovene	ganciclovir sodium	H2-Pharma, LLC	NDA	Current
61269-450	Cytovene	ganciclovir sodium	H2-Pharma, LLC	NDA	Current
61269-450	Cytovene	ganciclovir sodium	H2-Pharma, LLC	NDA	Current