Application 761036

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DARZALEX	DARATUMUMAB	INJECTABLE;INJECTION	100MG/5ML	Yes	No
002	DARZALEX	DARATUMUMAB	INJECTABLE;INJECTION	400MG/20ML	Yes	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
57894-502	DARZALEX	Daratumumab	Janssen Biotech, Inc.	BLA	Current
57894-502	DARZALEX	Daratumumab	Janssen Biotech, Inc.	BLA	Current
57894-502	DARZALEX	Daratumumab	Janssen Biotech, Inc.	BLA	Current
57894-502	DARZALEX	Daratumumab	Janssen Biotech, Inc.	BLA	Current
57894-502	DARZALEX	Daratumumab	Janssen Biotech, Inc.	BLA	Current
57894-502	DARZALEX	Daratumumab	Janssen Biotech, Inc.	BLA	Current
57894-502	DARZALEX	Daratumumab	Janssen Biotech, Inc.	BLA	Current
57894-502	DARZALEX	Daratumumab	Janssen Biotech, Inc.	BLA	Current
57894-502	DARZALEX	Daratumumab	Janssen Biotech, Inc.	BLA	Current
57894-502	DARZALEX	Daratumumab	Janssen Biotech, Inc.	BLA	Current
57894-502	DARZALEX	Daratumumab	Janssen Biotech, Inc.	BLA	Current
57894-502	DARZALEX	Daratumumab	Janssen Biotech, Inc.	BLA	Current
57894-502	DARZALEX	Daratumumab	Janssen Biotech, Inc.	BLA	Current
57894-502	DARZALEX	Daratumumab	Janssen Biotech, Inc.	BLA	Current
57894-502	DARZALEX	Daratumumab	Janssen Biotech, Inc.	BLA	Current
57894-502	DARZALEX	Daratumumab	Janssen Biotech, Inc.	BLA	Current
57894-502	DARZALEX	Daratumumab	Janssen Biotech, Inc.	BLA	Current
57894-505	Darzalex IV	Daratumumab	Janssen Biotech, Inc.	BLA	Current
57894-505	Darzalex IV	Daratumumab	Janssen Biotech, Inc.	BLA	Current
57894-505	Darzalex IV	Daratumumab	Janssen Biotech, Inc.	BLA	Current
57894-505	Darzalex IV	Daratumumab	Janssen Biotech, Inc.	BLA	Current
57894-505	Darzalex IV	Daratumumab	Janssen Biotech, Inc.	BLA	Current