FDA — authorised 4 May 1983
- Application: NDA018893
- Marketing authorisation holder: HOSPIRA
- Local brand name: SODIUM ACETATE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
🇺🇸 SODIUM ACETATE in United States
FDA authorised SODIUM ACETATE on 4 May 1983 · 524 US adverse-event reports
Marketing authorisations
FDA — authorised 30 October 2017
- Application: ANDA206687
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: SODIUM ACETATE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 4 May 2021
- Application: ANDA214805
- Marketing authorisation holder: MILLA PHARMS
- Local brand name: SODIUM ACETATE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 15 March 2024
- Application: ANDA216920
- Marketing authorisation holder: HIKMA
- Local brand name: SODIUM ACETATE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 8 August 2025
- Application: ANDA218469
- Marketing authorisation holder: AMNEAL
- Local brand name: SODIUM ACETATE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 18 September 2025
- Application: ANDA219826
- Marketing authorisation holder: SOMERSET THERAPS LLC
- Status: approved
FDA — authorised 17 April 2026
- Application: ANDA220274
- Marketing authorisation holder: EXTROVIS
- Local brand name: SODIUM ACETATE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA
- 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: 524
Most-reported reactions
- Pyrexia — 91 reports (17.37%)
- Nausea — 70 reports (13.36%)
- Off Label Use — 65 reports (12.4%)
- Diarrhoea — 61 reports (11.64%)
- Vomiting — 50 reports (9.54%)
- Anaemia — 41 reports (7.82%)
- Pneumonia — 40 reports (7.63%)
- Hypokalaemia — 37 reports (7.06%)
- General Physical Health Deterioration — 35 reports (6.68%)
- Death — 34 reports (6.49%)
SODIUM ACETATE 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 ACETATE approved in United States?
Yes. FDA authorised it on 4 May 1983; FDA authorised it on 30 October 2017; FDA authorised it on 4 May 2021.
Who is the marketing authorisation holder for SODIUM ACETATE in United States?
HOSPIRA holds the US marketing authorisation.