🇺🇸 vitamins in United States

FDA authorised vitamins on 21 February 2001 · 80,523 US adverse-event reports

Marketing authorisations

FDA — authorised 21 February 2001

  • Application: NDA021265
  • Marketing authorisation holder: SANDOZ CANADA INC
  • Status: supplemented

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.

Most-reported reactions

  1. Fatigue — 11,692 reports (14.52%)
  2. Nausea — 9,755 reports (12.11%)
  3. Drug Ineffective — 9,070 reports (11.26%)
  4. Headache — 8,392 reports (10.42%)
  5. Diarrhoea — 8,351 reports (10.37%)
  6. Pain — 7,219 reports (8.97%)
  7. Dizziness — 7,073 reports (8.78%)
  8. Off Label Use — 6,845 reports (8.5%)
  9. Dyspnoea — 6,460 reports (8.02%)
  10. Arthralgia — 5,666 reports (7.04%)

Source database →

Other Other approved in United States

Frequently asked questions

Is vitamins approved in United States?

Yes. FDA authorised it on 21 February 2001; FDA has authorised it.

Who is the marketing authorisation holder for vitamins in United States?

SANDOZ CANADA INC holds the US marketing authorisation.