JANSSEN BIOTECH Application 761210

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RYBREVANT	AMIVANTAMAB-VMJW	INJECTABLE;INJECTION	350MG/7ML(50MG/ML)	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
57894-501	Rybrevant	Amivantamab	Janssen Biotech, Inc.	BLA	Current
57894-501	Rybrevant	Amivantamab	Janssen Biotech, Inc.	BLA	Current
57894-501	Rybrevant	Amivantamab	Janssen Biotech, Inc.	BLA	Current
57894-501	Rybrevant	Amivantamab	Janssen Biotech, Inc.	BLA	Current
57894-501	Rybrevant	Amivantamab	Janssen Biotech, Inc.	BLA	Current