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FDA NDA · NDA218784

VORANIGO

vorasidenib

Sponsor: SERVIER

APPLICATION
NDA218784
TYPE
NDA
ORIGINAL APPROVAL
2024-08-06
LATEST ACTION
2026-06-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

VORANIGO · ReferencePrescription
VORASIDENIB 10MG · TABLET · ORAL
VORANIGO · ReferencePrescription
VORASIDENIB 40MG · TABLET · ORAL

Approval history

2026-06-10Labeling · Supplement 4 · standard — Letter ↗AP
2025-04-08Labeling · Supplement 2 · standard — Letter ↗AP
2024-08-06Type 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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