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FDA NDA · NDA217242

ZORYVE

roflumilast

Sponsor: ARCUTIS

APPLICATION
NDA217242
TYPE
NDA
ORIGINAL APPROVAL
2023-12-15
LATEST ACTION
2025-05-22
ROUTE
TOPICAL
DOSAGE FORM
FOAM
MARKETING STATUS
Prescription

Products

ZORYVE · ReferencePrescription
ROFLUMILAST 0.3% · FOAM · TOPICAL

Approval history

2025-05-22Efficacy · Supplement 5 · standard — Letter ↗AP
2024-06-12Manufacturing (CMC) · Supplement 2 — Label ↗AP
2023-12-15Type 3 - New Dosage Form and Type 4 - New Combination · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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