Regulatory PathRegulatory requirements compared

Active substance

Helium

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
HELIUM, USPN/Agas · inhalationNORCO INCPrescription14 Jul 2013
HELIUM, USPN/Agas · inhalationAIRGAS USA LLCPrescription20 Jul 2013
HELIUM, USPN/Agas · inhalationPRAXAIR DISTRIBUTION MID-ATLANTIC LLCPrescription5 Aug 2013
HELIUM, USPN/Agas · inhalationPRAXAIR DISTRIBUTION INCPrescription5 Aug 2013
HELIUM, USPN/Agas · inhalationAIR LIQUIDE HEALTHCARE AMERICA CORPPrescription7 Sep 2013
HELIUM, USPN/Agas · inhalationLINDE GAS NORTH AMERICA LLCPrescription4 Mar 2014
HELIUM, USPN/Agas · inhalationNEXAIR LLCPrescription20 Feb 2016
HELIUM, USPN/Agas · inhalationA-OX WELDING SUPPLY CO, INC.Prescription23 Apr 2018
HELIUM, USPN/Agas · inhalationMATHESON TRI-GAS INCPrescription16 Oct 2018
HELIUM, USPN/Agas · inhalationROBERTS OXYGEN CO INCPrescription14 Jul 2019
HELIUM, USPN/Agas · inhalationA G L WELDING SUPPLY CO INCPrescription18 Aug 2019
HELIUM, USPN/Agas · inhalationILMO Products CompanyPrescription27 Oct 2019
HELIUM, USPN/Agas · inhalationWESTAIR GASES & EQUIPMENT INCPrescription27 Jun 2020
HELIUM, USPN/Agas · inhalationGENERAL AIR SERVICE & SUPPLY COMPANYPrescription26 Jul 2021
HELIUM, USPN/Agas · inhalationPRAXAIR INCDiscontinued21 Jul 2013
HELIUM, USPN/Agas · inhalationAIR PRODUCTS AND CHEMICALS INCDiscontinued

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
HELIUM 100%00572888100 %GAS · INHALATIONAIR LIQUIDE CANADA INC.
HELIUM USP0201447599 % / V/VGAS · INHALATIONLINDE CANADA INC.

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.