FDA — authorised 16 June 2013
- Application: NDA205704
- Marketing authorisation holder: AIR LIQUIDE AMERICA SPECIALITY GASES
- Local brand name: NITROUS OXIDE, USP
- Indication: GAS — INHALATION
- Status: approved
🇺🇸 Dinitrogen Oxide in United States
FDA authorised Dinitrogen Oxide on 16 June 2013
Marketing authorisations
FDA — authorised 3 September 2013
- Application: NDA206009
- Marketing authorisation holder: NITROUS OXIDE CORP
- Local brand name: NITROUS OXIDE, USP
- Indication: GAS — INHALATION
- Status: approved
FDA — authorised 6 September 2013
- Application: NDA206014
- Marketing authorisation holder: NITROUS OXIDE OF CANADA
- Local brand name: NITROUS OXIDE, USP
- Indication: GAS — INHALATION
- Status: approved
FDA — authorised 25 November 2014
- Application: NDA208069
- Marketing authorisation holder: STRATA MEDICAL INNOVATIONS
- Local brand name: NITROUS OXIDE, USP
- Indication: GAS — INHALATION
- Status: approved
FDA — authorised 9 January 2017
- Application: NDA209989
- Marketing authorisation holder: MATHESON TRI-GAS INC
- Local brand name: NITROUS OXIDE, USP
- Indication: GAS — INHALATION
- Status: approved
FDA
- Status: approved
Dinitrogen Oxide in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Pain approved in United States
Frequently asked questions
Is Dinitrogen Oxide approved in United States?
Yes. FDA authorised it on 16 June 2013; FDA authorised it on 3 September 2013; FDA authorised it on 6 September 2013.
Who is the marketing authorisation holder for Dinitrogen Oxide in United States?
AIR LIQUIDE AMERICA SPECIALITY GASES holds the US marketing authorisation.