🇺🇸 OXYGEN in United States

FDA authorised OXYGEN on 16 June 2013 · 41,953 US adverse-event reports

Marketing authorisations

FDA — authorised 16 June 2013

  • Application: NDA205713
  • Marketing authorisation holder: AIR LIQUID INDUSTRIAL US LP
  • Local brand name: OXYGEN, USP
  • Indication: GAS — INHALATION
  • Status: approved

Read official source →

FDA — authorised 16 June 2013

  • Application: NDA205712
  • Marketing authorisation holder: AIR LIQUID INDUSTRIAL US LP
  • Local brand name: OXYGEN, USP
  • Indication: GAS — INHALATION
  • Status: approved

Read official source →

FDA — authorised 23 June 2013

  • Application: NDA205737
  • Marketing authorisation holder: AIR LIQUIDE LARGE INDUSTRIES US LP
  • Local brand name: OXYGEN, USP
  • Indication: GAS — INHALATION
  • Status: approved

Read official source →

FDA — authorised 5 July 2013

  • Application: NDA205817
  • Marketing authorisation holder: LINDE NORTH AMERICA INC
  • Local brand name: OXYGEN, USP
  • Indication: GAS — INHALATION
  • Status: approved

Read official source →

FDA — authorised 5 July 2013

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

FDA — authorised 5 July 2013

  • Application: NDA205767
  • Marketing authorisation holder: LINDE NORTH AMERICA INC
  • Local brand name: OXYGEN, USP
  • Indication: GAS — INHALATION
  • Status: approved

Read official source →

FDA — authorised 5 July 2013

  • Application: NDA205818
  • Marketing authorisation holder: LINDE GAS PUERTO RICO INC
  • Local brand name: OXYGEN, USP
  • Indication: GAS — INHALATION
  • Status: approved

Read official source →

FDA — authorised 14 July 2013

  • Application: NDA205820
  • Marketing authorisation holder: NORCO INC
  • Local brand name: OXYGEN, USP
  • Indication: GAS — INHALATION
  • Status: approved

Read official source →

FDA — authorised 23 July 2013

  • Application: NDA205865
  • Marketing authorisation holder: AIR PRODUCTS AND CHEMICALS INC
  • Local brand name: OXYGEN, USP
  • Indication: GAS — INHALATION
  • Status: approved

Read official source →

FDA — authorised 2 August 2013

  • Application: NDA205889
  • Marketing authorisation holder: MATHESON TRI-GAS INC
  • Local brand name: OXYGEN, USP
  • Indication: GAS — INHALATION
  • Status: approved

Read official source →

FDA — authorised 27 August 2013

  • Application: NDA205986
  • Marketing authorisation holder: PRAXAIR CANADA INC
  • Local brand name: OXYGEN, USP
  • Indication: GAS — INHALATION
  • Status: approved

Read official source →

FDA — authorised 7 September 2013

  • Application: NDA206023
  • Marketing authorisation holder: AIRGAS USA LLC
  • Local brand name: OXYGEN, USP
  • Indication: GAS — INHALATION
  • Status: approved

Read official source →

FDA — authorised 3 September 2017

  • Application: NDA210844
  • Marketing authorisation holder: PRAXAIR MEXICO
  • Local brand name: OXYGEN, USP
  • Indication: GAS — INHALATION
  • Status: approved

Read official source →

FDA — authorised 17 December 2017

  • Application: NDA211270
  • Marketing authorisation holder: LINDE GAS PUERTO RICO INC
  • Indication: Medical Gas
  • Status: approved

Read official source →

FDA — authorised 24 August 2018

  • Application: NDA212314
  • Marketing authorisation holder: UNIVERSAL INDUSTRIAL GASES, INC
  • Status: approved

FDA — authorised 10 September 2018

  • Application: NDA211739
  • Marketing authorisation holder: CRISTAL ASU LLC
  • Local brand name: OXYGEN, USP
  • Indication: GAS — INHALATION
  • Status: approved

Read official source →

FDA — authorised 2 June 2020

  • Application: NDA214857
  • Marketing authorisation holder: AIR LIQUIDE CANADA INC
  • Local brand name: OXYGEN, USP
  • Indication: GAS — INHALATION
  • Status: approved

Read official source →

FDA — authorised 10 June 2022

  • Application: NDA217500
  • Marketing authorisation holder: ABSOLUTE AIR, LLC
  • Local brand name: OXYGEN, USP
  • Indication: GAS — INHALATION
  • Status: approved

Read official source →

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 — 9,395 reports (22.39%)
  2. Cough — 4,363 reports (10.4%)
  3. Headache — 4,314 reports (10.28%)
  4. Diarrhoea — 3,908 reports (9.32%)
  5. Fatigue — 3,872 reports (9.23%)
  6. Pneumonia — 3,841 reports (9.16%)
  7. Nausea — 3,728 reports (8.89%)
  8. Dizziness — 3,155 reports (7.52%)
  9. Oxygen Saturation Decreased — 2,855 reports (6.81%)
  10. Death — 2,522 reports (6.01%)

Source database →

OXYGEN in other countries

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

Frequently asked questions

Is OXYGEN approved in United States?

Yes. FDA authorised it on 16 June 2013; FDA authorised it on 16 June 2013; FDA authorised it on 23 June 2013.

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

AIR LIQUID INDUSTRIAL US LP holds the US marketing authorisation.