General MedicationsORALStandard
TAFINLAR
DABRAFENIB MESYLATE
Standard Dose
75MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: UNKNOWN Marketing status: Prescription
Summary
Approval overview TAFINLAR is listed in Drugs@FDA under application 217514 (NDA).
Review priority: UNKNOWN Marketing status: Prescription Active ingredient DABRAFENIB MESYLATE Form and strength CAPSULE;ORAL - 75MG Sponsor NOVARTIS Submission history Latest submission status date: 2026-03-26 00:00:00.
Structured Monograph
Clinical summary
Approval overview TAFINLAR is listed in Drugs@FDA under application 217514 (NDA). Review priority: UNKNOWN Marketing status: Prescription Active ingredient DABRAFENIB MESYLATE Form and strength CAPSULE;ORAL - 75MG Sponsor NOVARTIS Submission history Latest submission status date: 2026-03-26 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: UNKNOWN
Interaction Notes
- No interaction notes stored yet.