Treats iron deficiency anemia. ANDA 78215, held by Hikma. Sodium Ferric Gluconate Complex.
As of Nov 15, 2026, ANDA 78215 (Sodium Ferric Gluconate Complex In Sucrose), held by Hikma, was first approved by FDA on Mar 31, 2011, with 5 approved supplements and 0 published complete response letters.
Sodium ferric gluconate complex in sucrose injection is indicated for the treatment of iron deficiency anemia in adult patients and in pediatric patients age 6 years and older with chronic kidney disease receiving hemodialysis who are receiving supplemental epoetin therapy. Sodium ferric gluconate complex in sucrose injection is an iron replacement product for treatment of iron deficiency anemia in adult patients and in pediatric patients age 6 years and older with chronic kidney disease receiving hemodialysis who are receiving supplemental epoetin therapy.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 31, 2011 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Sodium Ferric Gluconate Complex In SucroseEQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML) · injectable;injection | Sodium Ferric Gluconate Complex | Rx |
| Sep 9, 2025 | Supplement 9Labeling · Standard review | Approved | None posted |
| Sep 9, 2025 | Supplement 11Labeling · Standard review | Approved | None posted |
| Sep 9, 2025 | Supplement 14Labeling · Standard review | Approved | None posted |
| Feb 28, 2012 | Supplement 1Labeling | Approved | None posted |
| Feb 28, 2012 | Supplement 2Labeling | Approved | None posted |
| Mar 31, 2011 | Original application | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
