Application 217242

Type: NDA
Sponsor: ARCUTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZORYVE	ROFLUMILAST	FOAM;TOPICAL	0.3%	Yes	Yes

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82436	SUPPL	2025-06-03
82317	SUPPL	2025-05-27
79551	SUPPL	2024-09-06
79548	SUPPL	2024-09-06
78205	ORIG	2024-04-23
77064	ORIG	2023-12-19
76874	ORIG	2023-12-15