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General MedicationsORALStandard

NUZOLVENCE

ZOLIFLODACIN

Standard Dose
3GM/PACKET
Max Dose
Refer to approved labeling
Primary Use
Review priority: PRIORITY Marketing status: Prescription
Summary

Approval overview NUZOLVENCE is listed in Drugs@FDA under application 219491 (NDA).

Review priority: PRIORITY Marketing status: Prescription Active ingredient ZOLIFLODACIN Form and strength FOR SUSPENSION;ORAL - 3GM/PACKET Sponsor ENTASIS THERAP Submission history Latest submission status date: 2025-12-12 00:00:00.

Structured Monograph

Clinical summary

Approval overview NUZOLVENCE is listed in Drugs@FDA under application 219491 (NDA). Review priority: PRIORITY Marketing status: Prescription Active ingredient ZOLIFLODACIN Form and strength FOR SUSPENSION;ORAL - 3GM/PACKET Sponsor ENTASIS THERAP Submission history Latest submission status date: 2025-12-12 00:00:00. Submission type: ORIG.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: PRIORITY

Interaction Notes

  • No interaction notes stored yet.