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FDA NDA · NDA215985

ZORYVE

roflumilast

Sponsor: ARCUTIS

APPLICATION
NDA215985
TYPE
NDA
ORIGINAL APPROVAL
2022-07-29
LATEST ACTION
2026-06-29
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription

Products

ZORYVE · ReferencePrescription
ROFLUMILAST 0.05% · CREAM · TOPICAL
ZORYVE · ReferencePrescription
ROFLUMILAST 0.3% · CREAM · TOPICAL
ZORYVE · ReferencePrescription
ROFLUMILAST 0.15% · CREAM · TOPICAL

Approval history

2026-06-29Efficacy · Supplement 15 · standard — Letter ↗AP
2025-10-04Efficacy · Supplement 12 · standard — Letter ↗AP
2024-07-09Efficacy · Supplement 7 · standard — Letter ↗AP
2023-10-05Efficacy · Supplement 2 · standard — Letter ↗AP
2022-07-29Type 3 - New Dosage Form · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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