ARCUTIS BIOTHERAPEUTICS, INC. Application 215985

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZORYVE	ROFUMILAST	CREAM;TOPICAL	0.3%	No	No
002	ZORYVE	ROFLUMILAST	CREAM;TOPICAL	0.15%	Yes	Yes
003	ZORYVE	ROFLUMILAST	CREAM;TOPICAL	0.05%	Yes	Yes

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
80610-130	roflumilast	roflumilast	Arcutis Biotherapeutics, Inc.	NDA	Current
80610-130	ZORYVE	roflumilast	Arcutis Biotherapeutics, Inc.	NDA	Current