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General MedicationsINJECTIONStandard

OPDIVO

NIVOLUMAB

Standard Dose
40MG/4ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: PRIORITY Marketing status: Prescription
Summary

Approval overview OPDIVO is listed in Drugs@FDA under application 125554 (BLA).

Review priority: PRIORITY Marketing status: Prescription Active ingredient NIVOLUMAB Form and strength INJECTABLE;INJECTION - 40MG/4ML Sponsor BRISTOL MYERS SQUIBB Submission history Latest submission status date: 2026-03-20 00:00:00.

Structured Monograph

Clinical summary

Approval overview OPDIVO is listed in Drugs@FDA under application 125554 (BLA). Review priority: PRIORITY Marketing status: Prescription Active ingredient NIVOLUMAB Form and strength INJECTABLE;INJECTION - 40MG/4ML Sponsor BRISTOL MYERS SQUIBB Submission history Latest submission status date: 2026-03-20 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.