General MedicationsORALStandard
SIRTURO
BEDAQUILINE FUMARATE
Standard Dose
EQ 20MG BASE
Max Dose
Refer to approved labeling
Primary Use
Review priority: PRIORITY Marketing status: Prescription
Summary
Approval overview SIRTURO is listed in Drugs@FDA under application 204384 (NDA).
Review priority: PRIORITY Marketing status: Prescription Active ingredient BEDAQUILINE FUMARATE Form and strength TABLET;ORAL - EQ 20MG BASE Sponsor JANSSEN THERAP Submission history Latest submission status date: 2025-07-28 00:00:00.
Structured Monograph
Clinical summary
Approval overview SIRTURO is listed in Drugs@FDA under application 204384 (NDA). Review priority: PRIORITY Marketing status: Prescription Active ingredient BEDAQUILINE FUMARATE Form and strength TABLET;ORAL - EQ 20MG BASE Sponsor JANSSEN THERAP Submission history Latest submission status date: 2025-07-28 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: PRIORITY
Interaction Notes
- No interaction notes stored yet.