General MedicationsORALStandard
TAFINLAR
DABRAFENIB MESYLATE
Standard Dose
EQ 75MG BASE
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview TAFINLAR is listed in Drugs@FDA under application 202806 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient DABRAFENIB MESYLATE Form and strength CAPSULE;ORAL - EQ 75MG BASE 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 202806 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient DABRAFENIB MESYLATE Form and strength CAPSULE;ORAL - EQ 75MG BASE Sponsor NOVARTIS Submission history Latest submission status date: 2026-03-26 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.