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General MedicationsINTRAVENOUSStandard

BAXDELA

DELAFLOXACIN MEGLUMINE

Standard Dose
EQ 300MG BASE/VIAL
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview BAXDELA is listed in Drugs@FDA under application 208611 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient DELAFLOXACIN MEGLUMINE Form and strength POWDER;INTRAVENOUS - EQ 300MG BASE/VIAL Sponsor MELINTA Submission history Latest submission status date: 2023-12-01 00:00:00.

Structured Monograph

Clinical summary

Approval overview BAXDELA is listed in Drugs@FDA under application 208611 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient DELAFLOXACIN MEGLUMINE Form and strength POWDER;INTRAVENOUS - EQ 300MG BASE/VIAL Sponsor MELINTA Submission history Latest submission status date: 2023-12-01 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.