FDA — authorised 17 October 2005
- Application: NDA021135
- Marketing authorisation holder: AM REGENT
- Indication: Efficacy
- Status: approved
🇺🇸 IRON SUCROSE in United States
FDA authorised IRON SUCROSE on 17 October 2005 · 1,824 US adverse-event reports
Marketing authorisations
FDA — authorised 8 August 2025
- Application: ANDA212559
- Marketing authorisation holder: MYLAN LABS LTD
- Status: approved
FDA — authorised 8 August 2025
- Application: ANDA212340
- Marketing authorisation holder: SANDOZ
- Status: approved
FDA — authorised 8 August 2025
- Application: ANDA208977
- Marketing authorisation holder: INTL MEDICATION SYS
- Local brand name: IRON SUCROSE
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
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.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 1,824
Most-reported reactions
- Off Label Use — 212 reports (11.62%)
- Nausea — 206 reports (11.29%)
- Drug Ineffective — 200 reports (10.96%)
- Arthralgia — 194 reports (10.64%)
- Dyspnoea — 189 reports (10.36%)
- Diarrhoea — 183 reports (10.03%)
- Rash — 179 reports (9.81%)
- Drug Hypersensitivity — 162 reports (8.88%)
- Hypertension — 159 reports (8.72%)
- Headache — 140 reports (7.68%)
IRON 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 IRON SUCROSE approved in United States?
Yes. FDA authorised it on 17 October 2005; FDA authorised it on 8 August 2025; FDA authorised it on 8 August 2025.
Who is the marketing authorisation holder for IRON SUCROSE in United States?
AM REGENT holds the US marketing authorisation.