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FDA NDA · NDA217513

MEKINIST

trametinib

Sponsor: NOVARTIS

APPLICATION
NDA217513
TYPE
NDA
ORIGINAL APPROVAL
2023-03-16
LATEST ACTION
2026-03-26
ROUTE
ORAL
DOSAGE FORM
SOLUTION, TABLET
MARKETING STATUS
Prescription

Products

MEKINISTPrescription
TRAMETINIB 4.7MG · SOLUTION · ORAL
MEKINIST · ReferencePrescription
TRAMETINIB DIMETHYL SULFOXIDE EQ 0.05MG BASE/ML · SOLUTION · ORAL
MEKINISTPrescription
TRAMETINIB 2MG · TABLET · ORAL

Approval history

2026-03-26Labeling · Supplement 11 · unknown — Letter ↗AP
2025-04-07Labeling · Supplement 9 · standard — Label ↗AP
2025-03-19Labeling · Supplement 8 · standard — Letter ↗AP
2025-03-07Efficacy · Supplement 5 · standard — Letter ↗AP
2025-01-24Labeling · Supplement 10 · standard — Letter ↗AP
2024-10-01Labeling · Supplement 7 · standard — Letter ↗AP
2024-07-11Labeling · Supplement 4 · standard — Letter ↗AP
2024-03-29Labeling · Supplement 3 · standard — Letter ↗AP
2024-02-27Labeling · Supplement 2 · standard — Label ↗AP
2023-03-16Type 5 - New Formulation or New Manufacturer · Original · priority — Label ↗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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