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General MedicationsINJECTIONStandard

IMAAVY

NIPOCALIMAB-AAHU

Standard Dose
300MG/1.62ML(185MG/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: PRIORITY Marketing status: Prescription
Summary

Approval overview IMAAVY is listed in Drugs@FDA under application 761430 (BLA).

Review priority: PRIORITY Marketing status: Prescription Active ingredient NIPOCALIMAB-AAHU Form and strength INJECTABLE;INJECTION - 300MG/1.62ML(185MG/ML) Sponsor JANSSEN BIOTECH Submission history Latest submission status date: 2025-04-29 00:00:00.

Structured Monograph

Clinical summary

Approval overview IMAAVY is listed in Drugs@FDA under application 761430 (BLA). Review priority: PRIORITY Marketing status: Prescription Active ingredient NIPOCALIMAB-AAHU Form and strength INJECTABLE;INJECTION - 300MG/1.62ML(185MG/ML) Sponsor JANSSEN BIOTECH Submission history Latest submission status date: 2025-04-29 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.