APPLICATION
ANDA078215
TYPE
ANDA
ORIGINAL APPROVAL
2011-03-31
LATEST ACTION
2025-09-09
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSEPrescription
SODIUM FERRIC GLUCONATE COMPLEX EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML) · INJECTABLE · INJECTION
Approval history
2025-09-09Labeling · Supplement 9 · standardAP
2025-09-09Labeling · Supplement 11 · standardAP
2025-09-09Labeling · Supplement 14 · standardAP
2012-02-28Labeling · Supplement 1AP
2012-02-28Labeling · Supplement 2AP
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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