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General MedicationsORAL SUSPENSIONStandard

TAFINLAR

DABRAFENIB MESYLATE

Standard Dose
10MG
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 TABLET; ORAL SUSPENSION - 10MG 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 TABLET; ORAL SUSPENSION - 10MG 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.