🇺🇸 Chloraprep in United States

FDA authorised Chloraprep on 14 July 2000 · 14,852 US adverse-event reports

Marketing authorisations

FDA — authorised 14 July 2000

  • Application: NDA020832
  • Marketing authorisation holder: BECTON DICKINSON CO
  • Status: approved

FDA — authorised 7 October 2002

  • Application: NDA021555
  • Marketing authorisation holder: BECTON DICKINSON CO
  • 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. Rash — 1,722 reports (11.59%)
  2. Pruritus — 1,653 reports (11.13%)
  3. Sinusitis — 1,573 reports (10.59%)
  4. Joint Swelling — 1,515 reports (10.2%)
  5. Fatigue — 1,462 reports (9.84%)
  6. Hypersensitivity — 1,440 reports (9.7%)
  7. Folliculitis — 1,399 reports (9.42%)
  8. Swelling — 1,365 reports (9.19%)
  9. Pain — 1,363 reports (9.18%)
  10. Impaired Healing — 1,360 reports (9.16%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Chloraprep approved in United States?

Yes. FDA authorised it on 14 July 2000; FDA authorised it on 7 October 2002; FDA has authorised it.

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

BECTON DICKINSON CO holds the US marketing authorisation.