Application 125249

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ARCALYST	RILONACEPT	VIAL; SINGLE-USE	220MG	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
61755-001	Arcalyst	rilonacept	Regeneron Pharmaceuticals, Inc.	BLA	Current
61755-001	Arcalyst	rilonacept	Regeneron Pharmaceuticals, Inc.	BLA	Current
61755-001	Arcalyst	rilonacept	Regeneron Pharmaceuticals, Inc.	BLA	Current
61755-001	Arcalyst	rilonacept	Regeneron Pharmaceuticals, Inc.	BLA	Current
61755-001	Arcalyst	rilonacept	Regeneron Pharmaceuticals, Inc.	BLA	Current
73604-914	Arcalyst	rilonacept	Kiniksa Pharmaceuticals (UK), Ltd.	BLA	Current
73604-914	Arcalyst	rilonacept	Kiniksa Pharmaceuticals (UK), Ltd.	BLA	Current