Treats iron deficiency anemia. NDA 20955, held by Sanofi Aventis US. Sodium Ferric Gluconate Complex.
As of Nov 13, 2026, NDA 20955 (Ferrlecit), held by Sanofi Aventis US, was first approved by FDA on Feb 18, 1999, with 12 approved supplements and 0 published complete response letters.
Ferrlecit 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. Ferrlecit 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.
| Aug 13, 2004 | Supplement 6Efficacy (new indication or use) · Priority review | Approved | |
| Feb 2, 2001 | Supplement 3Efficacy (new indication or use) · Priority review | Approved | |
| Feb 18, 1999 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| FerrlecitEQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML) · injectable;injection | Sodium Ferric Gluconate Complex | RxReference drug |
| Mar 16, 2022 | Supplement 20Labeling · Standard review | Approved | |
| Dec 2, 2020 | Supplement 19Labeling · Standard review | Approved | |
| Mar 31, 2020 | Supplement 17Labeling · Standard review | Approved | |
| Feb 1, 2013 | Supplement 16Manufacturing · Priority review | Approved | None posted |
| Aug 25, 2011 | Supplement 15Labeling | Approved | |
| Aug 25, 2011 | Supplement 13Labeling | Approved | |
| Oct 2, 2006 | Supplement 10Labeling · Standard review | Approved | |
| Aug 13, 2004 | Supplement 6Efficacy (new indication or use) · Priority review | Approved | |
| Jun 7, 2002 | Supplement 5Labeling · Standard review | Approved | |
| Apr 9, 2002 | Supplement 4Manufacturing · Priority review | Approved | None posted |
| Feb 2, 2001 | Supplement 3Efficacy (new indication or use) · Priority review | Approved | |
| Jul 27, 1999 | Supplement 1Manufacturing · Priority review | Approved | |
| Feb 18, 1999 | Original applicationNew molecular entity · Priority review | 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
