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General MedicationsINTRAVENOUSStandard

KIMYRSA

ORITAVANCIN DIPHOSPHATE

Standard Dose
EQ 1.2GM BASE/VIAL
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview KIMYRSA is listed in Drugs@FDA under application 214155 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient ORITAVANCIN DIPHOSPHATE Form and strength POWDER;INTRAVENOUS - EQ 1.2GM BASE/VIAL Sponsor MELINTA THERAP Submission history Latest submission status date: 2025-04-24 00:00:00.

Structured Monograph

Clinical summary

Approval overview KIMYRSA is listed in Drugs@FDA under application 214155 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient ORITAVANCIN DIPHOSPHATE Form and strength POWDER;INTRAVENOUS - EQ 1.2GM BASE/VIAL Sponsor MELINTA THERAP Submission history Latest submission status date: 2025-04-24 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.
KIMYRSA (ORITAVANCIN DIPHOSPHATE) | Drug Monograph | MedicHelpline