Application 761170

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PHESGO	PERTUZUMAB;TRASTUZUMAB;HYALURONIDASE-ZZXF	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	1200MG;600MG;30000UNITS	No	No
002	PHESGO	PERTUZUMAB;TRASTUZUMAB;HYALURONIDASE-ZZXF	INJECTABLE;SUBCUTANEOUS	600MG;600MG;20,000UNITS	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50242-245	Phesgo	pertuzumab, trastuzumab, and hyaluronidase-zzxf	Genentech, Inc.	BLA	Current
50242-245	Phesgo	pertuzumab, trastuzumab, and hyaluronidase-zzxf	Genentech, Inc.	BLA	Current
50242-245	Phesgo	pertuzumab, trastuzumab, and hyaluronidase-zzxf	Genentech, Inc.	BLA	Current
50242-245	Phesgo	pertuzumab, trastuzumab, and hyaluronidase-zzxf	Genentech, Inc.	BLA	Current
50242-260	Phesgo	pertuzumab, trastuzumab, and hyaluronidase-zzxf	Genentech, Inc.	BLA	Current
50242-260	Phesgo	pertuzumab, trastuzumab, and hyaluronidase-zzxf	Genentech, Inc.	BLA	Current
50242-260	Phesgo	pertuzumab, trastuzumab, and hyaluronidase-zzxf	Genentech, Inc.	BLA	Current
50242-260	Phesgo	pertuzumab, trastuzumab, and hyaluronidase-zzxf	Genentech, Inc.	BLA	Current