General MedicationsINTRAVENOUSStandard
IRON SUCROSE
IRON SUCROSE
Standard Dose
EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview IRON SUCROSE is listed in Drugs@FDA under application 212559 (ANDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient IRON SUCROSE Form and strength INJECTABLE;INTRAVENOUS - EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML) Sponsor MYLAN LABS LTD Submission history Latest submission status date: 2025-08-08 00:00:00.
Structured Monograph
Clinical summary
Approval overview IRON SUCROSE is listed in Drugs@FDA under application 212559 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient IRON SUCROSE Form and strength INJECTABLE;INTRAVENOUS - EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML) Sponsor MYLAN LABS LTD Submission history Latest submission status date: 2025-08-08 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.