General MedicationsORALStandard
BAXDELA
DELAFLOXACIN MEGLUMINE
Standard Dose
EQ 450MG BASE
Max Dose
Refer to approved labeling
Primary Use
Review priority: PRIORITY Marketing status: Prescription
Summary
Approval overview BAXDELA is listed in Drugs@FDA under application 208610 (NDA).
Review priority: PRIORITY Marketing status: Prescription Active ingredient DELAFLOXACIN MEGLUMINE Form and strength TABLET;ORAL - EQ 450MG BASE Sponsor MELINTA Submission history Latest submission status date: 2019-10-24 00:00:00.
Structured Monograph
Clinical summary
Approval overview BAXDELA is listed in Drugs@FDA under application 208610 (NDA). Review priority: PRIORITY Marketing status: Prescription Active ingredient DELAFLOXACIN MEGLUMINE Form and strength TABLET;ORAL - EQ 450MG BASE Sponsor MELINTA Submission history Latest submission status date: 2019-10-24 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: PRIORITY
Interaction Notes
- No interaction notes stored yet.