🇺🇸 Gastroview in United States

FDA authorised Gastroview on 2 September 1981 · 54 US adverse-event reports

Marketing authorisations

FDA — authorised 2 September 1981

  • Application: ANDA087388
  • Marketing authorisation holder: LIEBEL-FLARSHEIM
  • 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. Urticaria — 9 reports (16.67%)
  2. Incorrect Route Of Drug Administration — 7 reports (12.96%)
  3. Medication Error — 6 reports (11.11%)
  4. Nausea — 6 reports (11.11%)
  5. Dyspnoea — 5 reports (9.26%)
  6. Renal Failure — 5 reports (9.26%)
  7. Vomiting — 5 reports (9.26%)
  8. Convulsion — 4 reports (7.41%)
  9. Death — 4 reports (7.41%)
  10. Acute Kidney Injury — 3 reports (5.56%)

Source database →

Gastroview in other countries

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

Other Gastroenterology approved in United States

Frequently asked questions

Is Gastroview approved in United States?

Yes. FDA authorised it on 2 September 1981; FDA has authorised it.

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

LIEBEL-FLARSHEIM holds the US marketing authorisation.