← FDA DRUG APPROVALS

FDA NDA · NDA215309

OPZELURA

ruxolitinib

Sponsor: INCYTE CORP

APPLICATION
NDA215309
TYPE
NDA
ORIGINAL APPROVAL
2021-09-21
LATEST ACTION
2026-06-30
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription

Products

OPZELURA · ReferencePrescription
RUXOLITINIB PHOSPHATE EQ 1.5% BASE · CREAM · TOPICAL

Approval history

2026-06-30Labeling · Supplement 9 · standard — Letter ↗AP
2025-09-18Efficacy · Supplement 7 · standard — Letter ↗AP
2023-03-13Labeling · Supplement 4 · standard — Letter ↗AP
2022-07-18Efficacy · Supplement 1 · priority — Letter ↗AP
2021-09-21Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated · Original · priority — Letter ↗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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