JANSSEN BIOTECH Application 761291

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TECAYLI	TECLISTAMAB-CQYV	INJECTABLE;INJECTION	30MG/3ML(10MG/ML)	No	No
002	TECAYLI	TECLISTAMAB-CQYV	INJECTABLE;INJECTION	153MG/1.7ML(90MG/ML)	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
57894-449	TECVAYLI	teclistamab	Janssen Biotech, Inc.	BLA	Current
57894-449	TECVAYLI	teclistamab	Janssen Biotech, Inc.	BLA	Current
57894-450	TECVAYLI	teclistamab	Janssen Biotech, Inc.	BLA	Current
57894-450	TECVAYLI	teclistamab	Janssen Biotech, Inc.	BLA	Current