Treats iron deficiency anemia (IDA). Sold as Venofer. Every FDA application for this active ingredient: 1 branded and 3 generic.
As of Nov 15, 2026, FDA lists 4 applications for Iron Sucrose (sold as Venofer), first approved Nov 6, 2000, with 4 new uses approved and 0 published complete response letters.
| Shortage | Status | First posted | Updated |
|---|---|---|---|
| Iron Sucrose Injection | To Be Discontinued | May 21, 2026 | May 21, 2026 |
| Ferric Carboxymaltose Versus Iron Sucrose for Iron Deficiency Anemia After Radical Gastrectomy for Gastric CancerGastric Cancer (GC), Iron Deficiency Anemia (IDA) · Zhaojian Niu,MD | Phase 4 | Not yet recruiting | Aug 19, 2026 |
| Comparing Two Intravenous Iron Treatments for Anemia in Kurdish Pregnant WomenIron Deficiency Anemia in Pregnancy · Hawler Medical University | Not applicable | Not yet recruiting | Jul 23, 2026 |
| Management of Iron Deficiency Anemia in Hemodialysis PatientsIron Deficiency Anemia (IDA), ESRD (End Stage Renal Disease) · Beni-Suef University | Phase 2 | Active, not recruiting | Jul 15, 2026 |
| COMPARISON OF EFFICACY OF ORAL VS IV IRON THERAPY IN CHILDREN AGED 12-59 MONTHS, WITH IRON DEFICIENCY ANEMIAIron Deficiency Anemia in Children · Kharadar General Hospital | Phase 2 | Not yet recruiting | Jun 18, 2026 |
| Pilot Study Evaluating the Advantages of Sucrosomial® Iron Post-operative Supplementation vs Standard of Care After Cardiac SurgeryCardiac Surgery · Englewood Hospital and Medical Center | Early phase 1 | Recruiting | May 14, 2025 |
| Long-term Outcomes Sub-Study of Preoperative Combined Iron TherapyAnemia, Iron Deficiencies · Second Affiliated Hospital, Zhejiang University, School of Medicine | Not applicable | Recruiting | May 13, 2025 |
| Effect of Intravenously Iron Infusion on the Prevention and Treatment of Anemia in Ovarian CancerAnaemia in Ovarian Carcinoma · University of Saskatchewan | Phase 3 | Not yet recruiting | Feb 8, 2024 |
| Comparison Between Outcomes of Pregnant Women Treated With Ferinject vs. Venofer for Iron Deficiency AnemiaAnemia, Iron Deficiency, Pregnancy Anemia · Western Galilee Hospital-Nahariya | Phase 4 | Recruiting | Sep 29, 2023 |
| Nov 6, 2000 | VenoferNDA 21135 · New dosage form | Am Regent | 24 | Marketed |
| Aug 8, 2025 | Iron SucroseANDA 208977 | Intl Medication Sys | 0 | Marketed |
| Aug 8, 2025 | Iron SucroseANDA 212340 | Sandoz | 1 | Marketed |
| Aug 8, 2025 | Iron SucroseANDA 212559 | Mylan Labs Ltd | 0 | 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
Sandoz
Mylan Labs Ltd