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General MedicationsINTRAVENOUSStandard

INJECTAFER

FERRIC CARBOXYMALTOSE

Standard Dose
750MG IRON/15ML (50MG IRON/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview INJECTAFER is listed in Drugs@FDA under application 203565 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient FERRIC CARBOXYMALTOSE Form and strength SOLUTION;INTRAVENOUS - 750MG IRON/15ML (50MG IRON/ML) Sponsor AM REGENT Submission history Latest submission status date: 2025-01-03 00:00:00.

Structured Monograph

Clinical summary

Approval overview INJECTAFER is listed in Drugs@FDA under application 203565 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient FERRIC CARBOXYMALTOSE Form and strength SOLUTION;INTRAVENOUS - 750MG IRON/15ML (50MG IRON/ML) Sponsor AM REGENT Submission history Latest submission status date: 2025-01-03 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.