Heliox
Heliox 30/70
Approved
Approval ID
eadb21f3-7938-9d4a-e053-2995a90a54ae
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 17, 2023
Manufacturers
FDA
A-OX WELDING SUPPLY CO., INC.
DUNS: 024372385
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Heliox
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code10297-070
Application NumberNDA205767
Product Classification
M
Marketing Category
C73594
G
Generic Name
Heliox
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateOctober 17, 2023
FDA Product Classification
INGREDIENTS (2)
HELIUMInactive
Quantity: 700 mL in 1 L
Code: 206GF3GB41
Classification: IACT
OXYGENActive
Quantity: 300 mL in 1 L
Code: S88TT14065
Classification: ACTIB