🇺🇸 SUPREP Bowel Prep Kit in United States

FDA authorised SUPREP Bowel Prep Kit on 5 August 2010 · 86 US adverse-event reports

Marketing authorisations

FDA — authorised 5 August 2010

  • Application: NDA022372
  • Marketing authorisation holder: AZURITY
  • Local brand name: SUPREP BOWEL PREP KIT
  • Indication: SOLUTION — ORAL
  • Status: approved

Read official source →

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. Nausea — 14 reports (16.28%)
  2. Vomiting — 14 reports (16.28%)
  3. Abdominal Pain — 11 reports (12.79%)
  4. Headache — 10 reports (11.63%)
  5. Dizziness — 8 reports (9.3%)
  6. Abdominal Distension — 7 reports (8.14%)
  7. Dehydration — 7 reports (8.14%)
  8. Muscle Spasms — 6 reports (6.98%)
  9. Diarrhoea — 5 reports (5.81%)
  10. Blood Potassium Decreased — 4 reports (4.65%)

Source database →

SUPREP Bowel Prep Kit in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Metabolic approved in United States

Frequently asked questions

Is SUPREP Bowel Prep Kit approved in United States?

Yes. FDA authorised it on 5 August 2010; FDA has authorised it.

Who is the marketing authorisation holder for SUPREP Bowel Prep Kit in United States?

AZURITY holds the US marketing authorisation.