FDA — authorised 20 November 2008
- Application: NDA021881
- Marketing authorisation holder: SALIX PHARMS
- Indication: Labeling
- Status: approved
🇺🇸 SODIUM ASCORBATE in United States
FDA authorised SODIUM ASCORBATE on 20 November 2008 · 1,258 US adverse-event reports
Marketing authorisations
FDA — authorised 17 December 2019
- Application: ANDA090145
- Marketing authorisation holder: NOVEL LABS INC
- Indication: Labeling
- Status: approved
FDA — authorised 8 September 2023
- Application: NDA209381
- Marketing authorisation holder: SALIX
- Indication: Labeling
- 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: 1,258
Most-reported reactions
- Off Label Use — 165 reports (13.12%)
- Drug Ineffective — 151 reports (12%)
- Nausea — 148 reports (11.76%)
- Constipation — 129 reports (10.25%)
- Drug Hypersensitivity — 119 reports (9.46%)
- Drug Intolerance — 119 reports (9.46%)
- Pain — 115 reports (9.14%)
- Fatigue — 109 reports (8.66%)
- Pyrexia — 103 reports (8.19%)
- Headache — 100 reports (7.95%)
SODIUM ASCORBATE 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 ASCORBATE approved in United States?
Yes. FDA authorised it on 20 November 2008; FDA authorised it on 17 December 2019; FDA authorised it on 8 September 2023.
Who is the marketing authorisation holder for SODIUM ASCORBATE in United States?
SALIX PHARMS holds the US marketing authorisation.