APOTEX Application 205539

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DECITABINE	DECITABINE	INJECTABLE;INTRAVENOUS	50MG/VIAL	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68083-528	decitabine	decitabine	Gland Pharma Limited	ANDA	Current
69097-905	Decitabine	Decitabine	Cipla USA Inc.	ANDA	Current