🇺🇸 Sodium Ferric Gluconate Complex in Sucrose. in United States

FDA authorised Sodium Ferric Gluconate Complex in Sucrose. on 31 March 2011 · 45 US adverse-event reports

Marketing authorisation

FDA — authorised 31 March 2011

  • Application: ANDA078215
  • Marketing authorisation holder: HIKMA
  • Local brand name: SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

The FDA approved Sodium Ferric Gluconate Complex in Sucrose for use in the United States. The approval was granted to HIKMA, the marketing authorisation holder, on 9 September 2025. The application number for this approval is ANDA078215.

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Safety signals — FAERS

Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.

Most-reported reactions

  1. Nausea — 6 reports (13.33%)
  2. Off Label Use — 6 reports (13.33%)
  3. Constipation — 5 reports (11.11%)
  4. Abdominal Distension — 4 reports (8.89%)
  5. Abdominal Pain — 4 reports (8.89%)
  6. Appendicitis — 4 reports (8.89%)
  7. Appendicolith — 4 reports (8.89%)
  8. Ascites — 4 reports (8.89%)
  9. Cardiogenic Shock — 4 reports (8.89%)
  10. General Physical Health Deterioration — 4 reports (8.89%)

Source database →

Sodium Ferric Gluconate Complex in Sucrose. in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is Sodium Ferric Gluconate Complex in Sucrose. approved in United States?

Yes. FDA authorised it on 31 March 2011.

Who is the marketing authorisation holder for Sodium Ferric Gluconate Complex in Sucrose. in United States?

HIKMA holds the US marketing authorisation.