Application 103764

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SIMULECT	BASILIXIMAB	VIAL; SINGLE-USE	10MG	No	No
002	SIMULECT	BASILIXIMAB	VIAL; SINGLE-USE	20MG	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0078-0331	Simulect	basiliximab	Novartis Pharmaceuticals Corporation	BLA	Current
0078-0331	Simulect	basiliximab	Novartis Pharmaceuticals Corporation	BLA	Current
0078-0331	Simulect	basiliximab	Novartis Pharmaceuticals Corporation	BLA	Current
0078-0331	Simulect	basiliximab	Novartis Pharmaceuticals Corporation	BLA	Current
0078-0331	Simulect	basiliximab	Novartis Pharmaceuticals Corporation	BLA	Current
0078-0331	Simulect	basiliximab	Novartis Pharmaceuticals Corporation	BLA	Current
0078-0393	Simulect	basiliximab	Novartis Pharmaceuticals Corporation	BLA	Current
0078-0393	Simulect	basiliximab	Novartis Pharmaceuticals Corporation	BLA	Current
0078-0393	Simulect	basiliximab	Novartis Pharmaceuticals Corporation	BLA	Current
0078-0393	Simulect	basiliximab	Novartis Pharmaceuticals Corporation	BLA	Current
0078-0393	Simulect	basiliximab	Novartis Pharmaceuticals Corporation	BLA	Current
0078-0393	Simulect	basiliximab	Novartis Pharmaceuticals Corporation	BLA	Current