APPLICATION
NDA219868
TYPE
NDA
ORIGINAL APPROVAL
2025-10-16
LATEST ACTION
2025-10-16
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
FERABRIGHT · ReferencePrescription
FERUMOXYTOL EQ 510MG IRON/17ML (EQ 30MG IRON/ML) · SOLUTION · INTRAVENOUS
FERABRIGHT · ReferencePrescription
FERUMOXYTOL EQ 300MG IRON/10ML (EQ 30MG IRON/ML) · SOLUTION · INTRAVENOUS
Approval history
2025-10-16Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated · Original · standard — Letter ↗AP
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.
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