GENENTECH Application 761121

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	POLIVY	POLATUZUMAB VEDOTIN-PIIQ	INJECTABLE;INJECTION	140MG	No	No
002	POLIVY	POLATUZUMAB VEDOTIN-PIIQ	POWDER;INTRAVENOUS	30MG/VIAL	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50242-103	POLIVY	polatuzumab vedotin	Genentech, Inc.	BLA	Current
50242-103	POLIVY	polatuzumab vedotin	Genentech, Inc.	BLA	Current
50242-105	POLIVY	polatuzumab vedotin	Genentech, Inc.	BLA	Current
50242-105	POLIVY	polatuzumab vedotin	Genentech, Inc.	BLA	Current
50242-105	POLIVY	polatuzumab vedotin	Genentech, Inc.	BLA	Current
50242-105	POLIVY	polatuzumab vedotin	Genentech, Inc.	BLA	Current
50242-105	POLIVY	polatuzumab vedotin	Genentech, Inc.	BLA	Current