Active substance
Sodium ferric gluconate complex
- US FDA 2
- Safety 1
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| FERRLECIT | EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML) | injectable · injection | SANOFI AVENTIS US | Prescription | 18 Feb 1999 |
| SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE | EQ 62.5MG IRON/5ML (EQ 12.5MG IRON/ML) | injectable · injection | HIKMA PHARMS | Prescription | 31 Mar 2011 |
Safety signals and safety-related labeling changes
- US FDA 16 Mar 2022 FERRLECIT — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.