Treats iron deficiency anemia. Sold as Ferrlecit. Every FDA application for this active ingredient: 1 branded and 1 generic.
As of Nov 15, 2026, FDA lists 2 applications for Sodium Ferric Gluconate Complex (sold as Ferrlecit), first approved Feb 18, 1999, with 2 new uses approved and 0 published complete response letters.
| Feb 18, 1999 | FerrlecitNDA 20955 ยท New molecular entity | Sanofi Aventis US | 12 | Marketed |
| Mar 31, 2011 | Sodium Ferric Gluconate Complex In SucroseANDA 78215 | Hikma | 5 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
Sanofi Aventis US
Hikma