CardiovascularINTRAVENOUSStandard

RECARBRIO

CILASTATIN SODIUM; IMIPENEM; RELEBACTAM

Standard Dose

EQ 500MG BASE/VIAL;500MG/VIAL;250MG/VIAL

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Prescription

Summary

Approval overview RECARBRIO is listed in Drugs@FDA under application 212819 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient CILASTATIN SODIUM; IMIPENEM; RELEBACTAM Form and strength POWDER;INTRAVENOUS - EQ 500MG BASE/VIAL;500MG/VIAL;250MG/VIAL Sponsor MSD MERCK CO Submission history Latest submission status date: 2025-12-09 00:00:00.

Structured Monograph

Clinical summary

Approval overview RECARBRIO is listed in Drugs@FDA under application 212819 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient CILASTATIN SODIUM; IMIPENEM; RELEBACTAM Form and strength POWDER;INTRAVENOUS - EQ 500MG BASE/VIAL;500MG/VIAL;250MG/VIAL Sponsor MSD MERCK CO Submission history Latest submission status date: 2025-12-09 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Prescription
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.