Home Applications 215985 Application 215985
Type NDA
Sponsor ARCUTIS BIOTHERAPEUTICS, INC. 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
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N215985-001 ZORYVE ROFLUMILAST 0.3% CREAM / TOPICAL RLD, RS 2022-07-29 N215985-002 ZORYVE ROFLUMILAST 0.15% CREAM / TOPICAL RLD, RS 2024-07-09 N215985-003 ZORYVE ROFLUMILAST 0.05% CREAM / TOPICAL RLD, RS 2025-10-04
Orange Book patents# Current patent rows page 1 of 1 · 50 matching rows.
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 3 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N215985-001 NPP 2026-10-05 N215985-002 NS 2027-07-09 N215985-003 NS 2028-10-04
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 N215985-001 ZORYVE 0.3% CREAM / TOPICAL RLD, RS 2022-07-29 a50c72e98297…2026-08-01 22:54:32 2026-06 N215985-002 ZORYVE 0.15% CREAM / TOPICAL RLD, RS 2024-07-09 a50c72e98297…2026-08-01 22:54:32 2026-06 N215985-003 ZORYVE 0.05% CREAM / TOPICAL RLD, RS 2025-10-04 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 2 · 50 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-01 22:54:32 2026-06 N215985-001 10940142 2037-06-07 Drug product 2022-08-19 a50c72e98297…2026-08-01 22:54:32 2026-06 N215985-001 11793796 2037-06-07 Drug product 2023-10-24 a50c72e98297…2026-08-01 22:54:32 2026-06 N215985-001 11819496 2037-06-07 U-3748 2023-11-21 a50c72e98297…2026-08-01 22:54:32 2026-06 N215985-001 11992480 2037-06-07 U-3748 2024-06-26 a50c72e98297…2026-08-01 22:54:32 2026-06 N215985-001 12005051 2037-06-07 U-3748 2024-07-09 a50c72e98297…2026-08-01 22:54:32 2026-06 N215985-001 12005052 2037-06-07 Drug product 2024-07-09 a50c72e98297…2026-08-01 22:54:32 2026-06 N215985-001 12011437 2037-06-07 Drug product 2024-07-09 a50c72e98297…2026-08-01 22:54:32 2026-06 N215985-001 12016848 2037-06-07 Drug product 2024-07-09 a50c72e98297…2026-08-01 22:54:32 2026-06 N215985-001 12042487 2037-06-07 Drug product 2024-08-21 a50c72e98297…2026-08-01 22:54:32 2026-06 N215985-001 12220409 2037-06-07 Drug product 2025-03-07 a50c72e98297…2026-08-01 22:54:32 2026-06 N215985-001 12257242 2037-06-07 Drug product 2025-04-22 a50c72e98297…2026-08-01 22:54:32 2026-06 N215985-001 12310956 2037-06-07 U-3748 2025-06-26 a50c72e98297…2026-08-01 22:54:32 2026-06 N215985-001 12336983 2037-06-07 Drug product 2025-07-22 a50c72e98297…2026-08-01 22:54:32 2026-06 N215985-001 9884050 2037-06-07 Drug product 2022-08-19 a50c72e98297…2026-08-01 22:54:32 2026-06 N215985-001 9907788 2037-06-07 U-3712 2022-08-19 a50c72e98297…2026-08-01 22:54:32 2026-06 N215985-001 9907788 2037-06-07 U-3408 2022-08-19 a50c72e98297…2026-08-01 22:54:32 2026-06 N215985-001 11129818 2037-08-25 U-3712 2022-08-19 a50c72e98297…2026-08-01 22:54:32 2026-06 N215985-001 11129818 2037-08-25 U-3408 2022-08-19 a50c72e98297…2026-08-01 22:54:32 2026-06 N215985-002 10940142 2037-06-07 Drug product 2024-08-08 a50c72e98297…2026-08-01 22:54:32 2026-06 N215985-002 11793796 2037-06-07 Drug product 2024-08-08 a50c72e98297…2026-08-01 22:54:32 2026-06 N215985-002 11819496 2037-06-07 U-3970 2024-08-08 a50c72e98297…2026-08-01 22:54:32 2026-06 N215985-002 11992480 2037-06-07 U-3970 2024-08-08 a50c72e98297…2026-08-01 22:54:32 2026-06 N215985-002 12005051 2037-06-07 U-3970 2024-08-08 a50c72e98297…2026-08-01 22:54:32 2026-06 N215985-002 12005052 2037-06-07 Drug product 2024-08-08 a50c72e98297…2026-08-01 22:54:32 2026-06 N215985-002 12011437 2037-06-07 Drug product 2024-08-08 a50c72e98297…2026-08-01 22:54:32 2026-06 N215985-002 12016848 2037-06-07 Drug product 2024-08-08 a50c72e98297…2026-08-01 22:54:32 2026-06 N215985-002 12042487 2037-06-07 Drug product 2024-08-08 a50c72e98297…2026-08-01 22:54:32 2026-06 N215985-002 12220409 2037-06-07 Drug product 2025-03-07 a50c72e98297…2026-08-01 22:54:32 2026-06 N215985-002 12257242 2037-06-07 Drug product 2025-04-22 a50c72e98297…2026-08-01 22:54:32 2026-06 N215985-002 12310956 2037-06-07 U-3970 2025-06-26 a50c72e98297…2026-08-01 22:54:32 2026-06 N215985-002 12336983 2037-06-07 Drug product 2025-07-22 a50c72e98297…2026-08-01 22:54:32 2026-06 N215985-002 9884050 2037-06-07 Drug product 2024-08-08 a50c72e98297…2026-08-01 22:54:32 2026-06 N215985-002 9907788 2037-06-07 U-3970 2024-08-08 a50c72e98297…2026-08-01 22:54:32 2026-06 N215985-002 11129818 2037-08-25 U-3970 2024-08-08 a50c72e98297…2026-08-01 22:54:32 2026-06 N215985-003 10940142 2037-06-07 Drug product 2025-11-04 a50c72e98297…2026-08-01 22:54:32 2026-06 N215985-003 11793796 2037-06-07 Drug product 2025-11-04 a50c72e98297…2026-08-01 22:54:32 2026-06 N215985-003 11819496 2037-06-07 U-4301 2025-11-04 a50c72e98297…2026-08-01 22:54:32 2026-06 N215985-003 11992480 2037-06-07 U-4301 2025-11-04 a50c72e98297…2026-08-01 22:54:32 2026-06 N215985-003 12005051 2037-06-07 U-4301 2025-11-04 a50c72e98297…2026-08-01 22:54:32 2026-06 N215985-003 12005052 2037-06-07 Drug product 2025-11-04 a50c72e98297…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-08-01 22:54:32 2026-06 N215985-001 NPP 2026-10-05 a50c72e98297…2026-08-01 22:54:32 2026-06 N215985-002 NS 2027-07-09 a50c72e98297…2026-08-01 22:54:32 2026-06 N215985-003 NS 2028-10-04 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 2 matching rows.
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
Documents# Document, Submission type, Date table Document Submission type Date 83674 SUPPL 2025-10-06 83667 SUPPL 2025-10-06 79072 SUPPL 2024-12-03 79032 SUPPL 2024-07-10 75690 SUPPL 2023-10-10 75680 SUPPL 2023-10-06 72904 ORIG 2022-12-15 71690 ORIG 2022-08-01 71675 ORIG 2022-08-01