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General MedicationsINJECTIONStandard

ZINPLAVA

BEZLOTOXUMAB

Standard Dose
1000ML/40ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: PRIORITY Marketing status: Prescription
Summary

Approval overview ZINPLAVA is listed in Drugs@FDA under application 761046 (BLA).

Review priority: PRIORITY Marketing status: Prescription Active ingredient BEZLOTOXUMAB Form and strength INJECTABLE;INJECTION - 1000ML/40ML Sponsor MERCK SHARP DOHME Submission history Latest submission status date: 2023-05-26 00:00:00.

Structured Monograph

Clinical summary

Approval overview ZINPLAVA is listed in Drugs@FDA under application 761046 (BLA). Review priority: PRIORITY Marketing status: Prescription Active ingredient BEZLOTOXUMAB Form and strength INJECTABLE;INJECTION - 1000ML/40ML Sponsor MERCK SHARP DOHME Submission history Latest submission status date: 2023-05-26 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.