FDA — authorised 19 November 2014
- Application: ANDA204328
- Marketing authorisation holder: THE FEINSTEIN INST
- Status: approved
🇺🇸 Fluoride in United States
FDA authorised Fluoride on 19 November 2014 · 2,426 US adverse-event reports
Marketing authorisations
FDA — authorised 27 February 2015
- Application: ANDA204542
- Marketing authorisation holder: PRECISION NUCLEAR
- Status: approved
FDA — authorised 30 July 2015
- Application: ANDA203780
- Marketing authorisation holder: CARDINAL HEALTH 414
- Status: approved
FDA — authorised 28 September 2015
- Application: ANDA203890
- Marketing authorisation holder: PETNET
- Status: approved
FDA — authorised 24 June 2020
- Application: ANDA203777
- Marketing authorisation holder: 3D IMAGING DRUG
- Indication: Manufacturing (CMC)
- 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: 2,426
Most-reported reactions
- Fatigue — 301 reports (12.41%)
- Nausea — 285 reports (11.75%)
- Vomiting — 248 reports (10.22%)
- Pyrexia — 245 reports (10.1%)
- Pain — 238 reports (9.81%)
- Diarrhoea — 233 reports (9.6%)
- Dizziness — 226 reports (9.32%)
- Headache — 225 reports (9.27%)
- Pneumonia — 213 reports (8.78%)
- Arthralgia — 212 reports (8.74%)
Fluoride in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Fluoride approved in United States?
Yes. FDA authorised it on 19 November 2014; FDA authorised it on 27 February 2015; FDA authorised it on 30 July 2015.
Who is the marketing authorisation holder for Fluoride in United States?
THE FEINSTEIN INST holds the US marketing authorisation.