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CardiovascularINTRAVENOUSStandard

IMIPENEM AND CILASTATIN

CILASTATIN SODIUM; IMIPENEM

Standard Dose
EQ 500MG BASE/VIAL;500MG/VIAL
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview IMIPENEM AND CILASTATIN is listed in Drugs@FDA under application 207594 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient CILASTATIN SODIUM; IMIPENEM Form and strength POWDER;INTRAVENOUS - EQ 500MG BASE/VIAL;500MG/VIAL Sponsor HQ SPCLT PHARMA Submission history Latest submission status date: 2024-04-04 00:00:00.

Structured Monograph

Clinical summary

Approval overview IMIPENEM AND CILASTATIN is listed in Drugs@FDA under application 207594 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient CILASTATIN SODIUM; IMIPENEM Form and strength POWDER;INTRAVENOUS - EQ 500MG BASE/VIAL;500MG/VIAL Sponsor HQ SPCLT PHARMA Submission history Latest submission status date: 2024-04-04 00:00:00. Submission type: SUPPL.

Monitoring

  • Marketing status: Prescription
  • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.