Application 125261

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	STELARA	USTEKINUMAB	INJECTABLE; INJECTION	45MG/0.5ML	No	No
002	STELARA	USTEKINUMAB	INJECTABLE; INJECTION	90MG/1ML	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
57894-060	STELARA	ustekinumab	Janssen Biotech, Inc.	BLA	Current
57894-060	STELARA	ustekinumab	Janssen Biotech, Inc.	BLA	Current
57894-060	STELARA	ustekinumab	Janssen Biotech, Inc.	BLA	Current
57894-060	STELARA	ustekinumab	Janssen Biotech, Inc.	BLA	Current
57894-060	STELARA	ustekinumab	Janssen Biotech, Inc.	BLA	Current
57894-060	STELARA	ustekinumab	Janssen Biotech, Inc.	BLA	Current
57894-060	STELARA	ustekinumab	Janssen Biotech, Inc.	BLA	Current
57894-060	STELARA	ustekinumab	Janssen Biotech, Inc.	BLA	Current
57894-060	STELARA	ustekinumab	Janssen Biotech, Inc.	BLA	Current
57894-060	STELARA	ustekinumab	Janssen Biotech, Inc.	BLA	Current
57894-060	STELARA	ustekinumab	Janssen Biotech, Inc.	BLA	Current
57894-061	STELARA	ustekinumab	Janssen Biotech, Inc.	BLA	Current
57894-061	STELARA	ustekinumab	Janssen Biotech, Inc.	BLA	Current
57894-061	STELARA	ustekinumab	Janssen Biotech, Inc.	BLA	Current
57894-061	STELARA	ustekinumab	Janssen Biotech, Inc.	BLA	Current
57894-061	STELARA	ustekinumab	Janssen Biotech, Inc.	BLA	Current
57894-061	STELARA	ustekinumab	Janssen Biotech, Inc.	BLA	Current
57894-061	STELARA	ustekinumab	Janssen Biotech, Inc.	BLA	Current
57894-061	STELARA	ustekinumab	Janssen Biotech, Inc.	BLA	Current
57894-061	STELARA	ustekinumab	Janssen Biotech, Inc.	BLA	Current
57894-061	STELARA	ustekinumab	Janssen Biotech, Inc.	BLA	Current
57894-061	STELARA	ustekinumab	Janssen Biotech, Inc.	BLA	Current