SPECTRUM PHARMS Application 761148

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ROLONTIS	EFLAPEGRASTIM-XNST	INJECTABLE;SUBCUTANEOUS	13.2MG/0.6ML	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
76961-101	Rolvedon	eflapegrastim-xnst	Spectrum Pharmaceuticals, Inc.	BLA	Current
76961-101	Rolvedon	eflapegrastim-xnst	Spectrum Pharmaceuticals, Inc.	BLA	Current