FDA — authorised 13 October 1976
- Application: NDA011963
- Marketing authorisation holder: FERA PHARMS LLC
- Indication: Supplement
- Status: approved
🇺🇸 Iodide in United States
FDA authorised Iodide on 13 October 1976 · 3,944 US adverse-event reports
Marketing authorisations
FDA — authorised 27 May 1982
- Application: NDA018671
- Marketing authorisation holder: CARDINAL HEALTH 418
- Indication: Labeling
- Status: approved
FDA — authorised 28 February 1989
- Application: ANDA071910
- Marketing authorisation holder: CURIUM
- Status: supplemented
FDA — authorised 28 February 1989
- Application: ANDA071909
- Marketing authorisation holder: CURIUM
- Status: approved
FDA — authorised 13 September 2000
- Application: NDA018664
- Marketing authorisation holder: ANBEX
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 10 September 2002
- Application: ANDA076350
- Marketing authorisation holder: BTG INTL
- Status: approved
FDA — authorised 24 March 2016
- Application: ANDA206211
- Marketing authorisation holder: MISSION PHARMACAL
- Status: approved
FDA — authorised 5 February 2020
- Application: ANDA209166
- Marketing authorisation holder: INTL ISOTOPES
- 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: 3,944
Most-reported reactions
- Hypothyroidism — 1,121 reports (28.42%)
- Fatigue — 349 reports (8.85%)
- Dyspnoea — 347 reports (8.8%)
- Diarrhoea — 344 reports (8.72%)
- Nausea — 338 reports (8.57%)
- Headache — 317 reports (8.04%)
- Fall — 293 reports (7.43%)
- Arthralgia — 282 reports (7.15%)
- Asthenia — 278 reports (7.05%)
- Dizziness — 275 reports (6.97%)
Iodide 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 Iodide approved in United States?
Yes. FDA authorised it on 13 October 1976; FDA authorised it on 27 May 1982; FDA authorised it on 28 February 1989.
Who is the marketing authorisation holder for Iodide in United States?
FERA PHARMS LLC holds the US marketing authorisation.