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FDA NDA · NDA217514

TAFINLAR

dabrafenib

Sponsor: NOVARTIS

APPLICATION
NDA217514
TYPE
NDA
ORIGINAL APPROVAL
2023-03-16
LATEST ACTION
2026-03-26
ROUTE
ORAL, ORAL SUSPENSION
DOSAGE FORM
CAPSULE, TABLET, TABLET, FOR SUSPENSION
MARKETING STATUS
Prescription

Products

TAFINLARPrescription
DABRAFENIB MESYLATE 75MG · CAPSULE · ORAL
TAFINLARPrescription
DABRAFENIB MESYLATE 10MG · TABLET · ORAL SUSPENSION
TAFINLAR · ReferencePrescription
DABRAFENIB MESYLATE EQ 10MG BASE · TABLET, FOR SUSPENSION · 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 — Label ↗AP
2025-03-07Efficacy · Supplement 6 · standard — Letter ↗AP
2025-01-30Labeling · Supplement 10 · standard — Label ↗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
2023-03-16New Combination and 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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