APPLICATION
ANDA212340
TYPE
ANDA
ORIGINAL APPROVAL
2025-08-08
LATEST ACTION
2025-09-22
ROUTE
INTRAVENOUS, INTRAVITREAL
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
IRON SUCROSEPrescription
IRON SUCROSE EQ 100MG IRON/5ML (EQ 20MG IRON/ML) · INJECTABLE · INTRAVENOUS
IRON SUCROSEPrescription
IRON SUCROSE EQ 200MG IRON/10ML (EQ 20MG IRON/ML) · INJECTABLE · INTRAVENOUS
IRON SUCROSEPrescription
IRON SUCROSE EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML) · INJECTABLE · INTRAVENOUS
Approval history
2025-09-22Manufacturing (CMC) · Supplement 1 · unknownAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.