Drug Landscape ›
OXYGEN ›
Regulatory · United States
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
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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
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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
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FDA — authorised 5 July 2013
Application: NDA205817
Marketing authorisation holder: LINDE NORTH AMERICA INC
Local brand name: OXYGEN, USP
Indication: GAS — INHALATION
Status: approved
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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
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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
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FDA — authorised 14 July 2013
Application: NDA205820
Marketing authorisation holder: NORCO INC
Local brand name: OXYGEN, USP
Indication: GAS — INHALATION
Status: approved
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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
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FDA — authorised 2 August 2013
Application: NDA205889
Marketing authorisation holder: MATHESON TRI-GAS INC
Local brand name: OXYGEN, USP
Indication: GAS — INHALATION
Status: approved
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FDA — authorised 27 August 2013
Application: NDA205986
Marketing authorisation holder: PRAXAIR CANADA INC
Local brand name: OXYGEN, USP
Indication: GAS — INHALATION
Status: approved
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FDA — authorised 7 September 2013
Application: NDA206023
Marketing authorisation holder: AIRGAS USA LLC
Local brand name: OXYGEN, USP
Indication: GAS — INHALATION
Status: approved
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FDA — authorised 3 September 2017
Application: NDA210844
Marketing authorisation holder: PRAXAIR MEXICO
Local brand name: OXYGEN, USP
Indication: GAS — INHALATION
Status: approved
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FDA — authorised 17 December 2017
Application: NDA211270
Marketing authorisation holder: LINDE GAS PUERTO RICO INC
Indication: Medical Gas
Status: approved
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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
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FDA — authorised 2 June 2020
Application: NDA214857
Marketing authorisation holder: AIR LIQUIDE CANADA INC
Local brand name: OXYGEN, USP
Indication: GAS — INHALATION
Status: approved
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FDA — authorised 10 June 2022
Application: NDA217500
Marketing authorisation holder: ABSOLUTE AIR, LLC
Local brand name: OXYGEN, USP
Indication: GAS — INHALATION
Status: approved
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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.
Window: 20 April 2025 – 20 April 2026
Total reports: 41,953
Most-reported reactions
Dyspnoea — 9,395 reports (22.39%) Cough — 4,363 reports (10.4%) Headache — 4,314 reports (10.28%) Diarrhoea — 3,908 reports (9.32%) Fatigue — 3,872 reports (9.23%) Pneumonia — 3,841 reports (9.16%) Nausea — 3,728 reports (8.89%) Dizziness — 3,155 reports (7.52%) Oxygen Saturation Decreased — 2,855 reports (6.81%) 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.