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FDA NDA · NDA209606

IDHIFA

enasidenib mesylate

Sponsor: BRISTOL MYERS SQUIBB

APPLICATION
NDA209606
TYPE
NDA
ORIGINAL APPROVAL
2017-08-01
LATEST ACTION
2025-01-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

IDHIFA · ReferencePrescription
ENASIDENIB MESYLATE EQ 100MG BASE · TABLET · ORAL
IDHIFA · ReferencePrescription
ENASIDENIB MESYLATE EQ 50MG BASE · TABLET · ORAL

Approval history

2025-01-16Labeling · Supplement 7 · standard — Label ↗AP
2024-12-18Labeling · Supplement 8 · standard — Label ↗AP
2023-12-21Labeling · Supplement 6 · standard — Letter ↗AP
2021-07-26Manufacturing (CMC) · Supplement 5 — Letter ↗AP
2020-11-24Efficacy · Supplement 4 · priority — Label ↗AP
2019-09-27Labeling · Supplement 2 · standard — Letter ↗AP
2017-08-01Type 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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