KYOWA KIRIN Application 761051

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	POTELIGEO	MOGAMULIZUMAB-KPKC	INJECTABLE;INJECTION	20MG/5ML	Yes	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42747-761	POTELIGEO	mogamulizumab-kpkc	Kyowa Kirin, Inc.	BLA	Current
42747-761	POTELIGEO	mogamulizumab-kpkc	Kyowa Kirin, Inc.	BLA	Current
42747-761	POTELIGEO	mogamulizumab-kpkc	Kyowa Kirin, Inc.	BLA	Current
42747-761	POTELIGEO	mogamulizumab-kpkc	Kyowa Kirin, Inc.	BLA	Current
42747-761	POTELIGEO	mogamulizumab-kpkc	Kyowa Kirin, Inc.	BLA	Current
42747-761	POTELIGEO	mogamulizumab-kpkc	Kyowa Kirin, Inc.	BLA	Current
42747-761	POTELIGEO	mogamulizumab-kpkc	Kyowa Kirin, Inc.	BLA	Current