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General MedicationsINJECTIONStandard

SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE

SODIUM FERRIC GLUCONATE COMPLEX

Standard Dose
EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE is listed in Drugs@FDA under application 078215 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient SODIUM FERRIC GLUCONATE COMPLEX Form and strength INJECTABLE;INJECTION - EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML) Sponsor HIKMA Submission history Latest submission status date: 2025-09-09 00:00:00.

Structured Monograph

Clinical summary

Approval overview SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE is listed in Drugs@FDA under application 078215 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient SODIUM FERRIC GLUCONATE COMPLEX Form and strength INJECTABLE;INJECTION - EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML) Sponsor HIKMA Submission history Latest submission status date: 2025-09-09 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.