General MedicationsORALStandard
ACCRUFER
FERRIC MALTOL
Standard Dose
30MG IRON
Max Dose
Refer to approved labeling
Primary Use
Review priority: PRIORITY Marketing status: Prescription
Summary
Approval overview ACCRUFER is listed in Drugs@FDA under application 212320 (NDA).
Review priority: PRIORITY Marketing status: Prescription Active ingredient FERRIC MALTOL Form and strength CAPSULE;ORAL - 30MG IRON Sponsor SHIELD TX Submission history Latest submission status date: 2025-12-19 00:00:00.
Structured Monograph
Clinical summary
Approval overview ACCRUFER is listed in Drugs@FDA under application 212320 (NDA). Review priority: PRIORITY Marketing status: Prescription Active ingredient FERRIC MALTOL Form and strength CAPSULE;ORAL - 30MG IRON Sponsor SHIELD TX Submission history Latest submission status date: 2025-12-19 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: PRIORITY
Interaction Notes
- No interaction notes stored yet.