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FDA NDA · NDA214958

SOTYKTU

deucravacitinib

Sponsor: BRISTOL

APPLICATION
NDA214958
TYPE
NDA
ORIGINAL APPROVAL
2022-09-09
LATEST ACTION
2026-06-30
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

SOTYKTU · ReferencePrescription
DEUCRAVACITINIB 6MG · TABLET · ORAL

Approval history

2026-06-30Labeling · Supplement 6 · standard — Letter ↗AP
2026-03-06Efficacy · Supplement 2 · standard — Letter ↗AP
2025-10-27Manufacturing (CMC) · Supplement 3 — Label ↗AP
2022-09-09Type 1 - New Molecular Entity · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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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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