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General MedicationsINTRAVENOUSStandard

FERABRIGHT

FERUMOXYTOL

Standard Dose
EQ 300MG IRON/10ML (EQ 30MG IRON/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview FERABRIGHT is listed in Drugs@FDA under application 219868 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient FERUMOXYTOL Form and strength SOLUTION;INTRAVENOUS - EQ 300MG IRON/10ML (EQ 30MG IRON/ML) Sponsor COVIS Submission history Latest submission status date: 2025-10-16 00:00:00.

Structured Monograph

Clinical summary

Approval overview FERABRIGHT is listed in Drugs@FDA under application 219868 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient FERUMOXYTOL Form and strength SOLUTION;INTRAVENOUS - EQ 300MG IRON/10ML (EQ 30MG IRON/ML) Sponsor COVIS Submission history Latest submission status date: 2025-10-16 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.