← FDA DRUG APPROVALS

FDA NDA · NDA218944

REVUFORJ

revumenib

Sponsor: SYNDAX

APPLICATION
NDA218944
TYPE
NDA
ORIGINAL APPROVAL
2024-11-15
LATEST ACTION
2025-10-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

REVUFORJ · ReferencePrescription
REVUMENIB CITRATE EQ 110MG BASE · TABLET · ORAL
REVUFORJ · ReferencePrescription
REVUMENIB CITRATE EQ 160MG BASE · TABLET · ORAL
REVUFORJ · ReferencePrescription
REVUMENIB CITRATE EQ 25MG BASE · TABLET · ORAL

Approval history

2025-10-24Efficacy · Supplement 3 · priority — Label ↗AP
2024-11-15Type 1 - New Molecular Entity · Original · priority — 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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