General MedicationsORALStandard
BLUJEPA
GEPOTIDACIN MESYLATE
Standard Dose
EQ 750MG BASE
Max Dose
Refer to approved labeling
Primary Use
Review priority: PRIORITY Marketing status: Prescription
Summary
Approval overview BLUJEPA is listed in Drugs@FDA under application 218230 (NDA).
Review priority: PRIORITY Marketing status: Prescription Active ingredient GEPOTIDACIN MESYLATE Form and strength TABLET;ORAL - EQ 750MG BASE Sponsor GLAXOSMITHKLINE Submission history Latest submission status date: 2025-12-11 00:00:00.
Structured Monograph
Clinical summary
Approval overview BLUJEPA is listed in Drugs@FDA under application 218230 (NDA). Review priority: PRIORITY Marketing status: Prescription Active ingredient GEPOTIDACIN MESYLATE Form and strength TABLET;ORAL - EQ 750MG BASE Sponsor GLAXOSMITHKLINE Submission history Latest submission status date: 2025-12-11 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: PRIORITY
Interaction Notes
- No interaction notes stored yet.