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FDA NDA · NDA210498

MEKTOVI

binimetinib

Sponsor: ARRAY BIOPHARMA INC

APPLICATION
NDA210498
TYPE
NDA
ORIGINAL APPROVAL
2018-06-27
LATEST ACTION
2025-03-12
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

MEKTOVI · ReferencePrescription
BINIMETINIB 15MG · TABLET · ORAL

Approval history

2025-03-12Efficacy · Supplement 11 · standard — Letter ↗AP
2024-09-12Efficacy · Supplement 10 · standard — Label ↗AP
2023-10-11Efficacy · Supplement 9 · standard — Label ↗AP
2019-01-23Efficacy · Supplement 1 · standard — Label ↗AP
2018-06-27Type 1 - New Molecular Entity · Original · standard — Review ↗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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