Application 125326

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ARZERRA	OFATUMUMAB	INJECTABLE; INJECTION	100MG/5ML	No	No
002	KESIMPTA	OFATUMUMAB	INJECTABLE;INJECTION	20MG/0.4ML	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0078-0669	ARZERRA	ofatumumab	Novartis Pharmaceuticals Corporation	BLA	Current
0078-0669	ARZERRA	ofatumumab	Novartis Pharmaceuticals Corporation	BLA	Current
0078-0669	ARZERRA	ofatumumab	Novartis Pharmaceuticals Corporation	BLA	Current
0078-0669	ARZERRA	ofatumumab	Novartis Pharmaceuticals Corporation	BLA	Current
0078-0669	ARZERRA	ofatumumab	Novartis Pharmaceuticals Corporation	BLA	Current
0078-0690	ARZERRA	ofatumumab	Novartis Pharmaceuticals Corporation	BLA	Current
0078-0690	ARZERRA	ofatumumab	Novartis Pharmaceuticals Corporation	BLA	Current
0078-0690	ARZERRA	ofatumumab	Novartis Pharmaceuticals Corporation	BLA	Current
0078-0690	ARZERRA	ofatumumab	Novartis Pharmaceuticals Corporation	BLA	Current
0078-0690	ARZERRA	ofatumumab	Novartis Pharmaceuticals Corporation	BLA	Current
0078-1007	KESIMPTA	ofatumumab	Novartis Pharmaceuticals Corporation	BLA	Current
0078-1007	KESIMPTA	ofatumumab	Novartis Pharmaceuticals Corporation	BLA	Current
0078-1007	KESIMPTA	ofatumumab	Novartis Pharmaceuticals Corporation	BLA	Current
0078-1007	KESIMPTA	ofatumumab	Novartis Pharmaceuticals Corporation	BLA	Current
0078-1007	KESIMPTA	ofatumumab	Novartis Pharmaceuticals Corporation	BLA	Current