🇺🇸 Air in United States

FDA authorised Air on 5 July 2013 · 922 US adverse-event reports

Marketing authorisations

FDA — authorised 5 July 2013

  • Application: NDA205764
  • Marketing authorisation holder: LINDE NORTH AMERICA INC
  • Status: approved

FDA — authorised 5 July 2013

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

FDA — authorised 5 July 2013

  • Application: NDA205767
  • Marketing authorisation holder: LINDE NORTH AMERICA INC
  • Status: approved

FDA — authorised 13 July 2013

  • Application: NDA205796
  • Marketing authorisation holder: MACHINE & WELDING SUPPLY CO
  • Status: approved

FDA — authorised 14 July 2013

  • Application: NDA205804
  • Marketing authorisation holder: PURITY CYLINDER GASES, INC
  • 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. Dyspnoea — 193 reports (20.93%)
  2. Drug Ineffective — 112 reports (12.15%)
  3. Headache — 90 reports (9.76%)
  4. Asthma — 84 reports (9.11%)
  5. Pain — 81 reports (8.79%)
  6. Cough — 79 reports (8.57%)
  7. Nausea — 77 reports (8.35%)
  8. Pneumonia — 74 reports (8.03%)
  9. Product Quality Issue — 67 reports (7.27%)
  10. Fatigue — 65 reports (7.05%)

Source database →

Other Respiratory approved in United States

Frequently asked questions

Is Air approved in United States?

Yes. FDA authorised it on 5 July 2013; FDA authorised it on 5 July 2013; FDA authorised it on 5 July 2013.

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

LINDE NORTH AMERICA INC holds the US marketing authorisation.