🇺🇸 medical in United States

FDA authorised medical on 5 July 2013 · 622 US adverse-event reports

Marketing authorisations

FDA — authorised 5 July 2013

  • Application: NDA205765
  • Marketing authorisation holder: LINDE NORTH AMERICA INC
  • Status: approved

FDA — authorised 14 July 2013

  • Application: NDA205820
  • Marketing authorisation holder: NORCO INC
  • Status: approved

FDA — authorised 7 September 2013

  • Application: NDA206023
  • Marketing authorisation holder: AIRGAS USA LLC
  • Status: approved

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 — 101 reports (16.24%)
  2. Diarrhoea — 80 reports (12.86%)
  3. Fatigue — 72 reports (11.58%)
  4. Headache — 63 reports (10.13%)
  5. Pain — 58 reports (9.32%)
  6. Dizziness — 57 reports (9.16%)
  7. Dyspnoea — 52 reports (8.36%)
  8. Vomiting — 49 reports (7.88%)
  9. Drug Ineffective — 46 reports (7.4%)
  10. Arthralgia — 44 reports (7.07%)

Source database →

medical 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 medical approved in United States?

Yes. FDA authorised it on 5 July 2013; FDA authorised it on 14 July 2013; FDA authorised it on 7 September 2013.

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

LINDE NORTH AMERICA INC holds the US marketing authorisation.