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General MedicationsINJECTIONStandard

INMAZEB

ATOLTIVIMAB; ODESIVIMAB; MAFTIVIMAB

Standard Dose
16.7MG/1ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview INMAZEB is listed in Drugs@FDA under application 761169 (BLA).

Review priority: STANDARD Marketing status: Prescription Active ingredient ATOLTIVIMAB; ODESIVIMAB; MAFTIVIMAB Form and strength SOLUTION; INJECTION - 16.7MG/1ML Sponsor REGENERON PHARMACEUTICALS Submission history Latest submission status date: 2024-10-24 00:00:00.

Structured Monograph

Clinical summary

Approval overview INMAZEB is listed in Drugs@FDA under application 761169 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient ATOLTIVIMAB; ODESIVIMAB; MAFTIVIMAB Form and strength SOLUTION; INJECTION - 16.7MG/1ML Sponsor REGENERON PHARMACEUTICALS Submission history Latest submission status date: 2024-10-24 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.