Oxygen Helium Mixture 40/60
O2 40 HE 60 MIX
Approved
Approval ID
60ceae1b-78ec-3520-e053-2a91aa0a5b27
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 18, 2017
Manufacturers
FDA
Aero All Gas Company
DUNS: 004532065
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Oxygen Helium Mixture 40/60
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code10014-008
Application NumberNDA205840
Product Classification
M
Marketing Category
C73594
G
Generic Name
Oxygen Helium Mixture 40/60
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateDecember 18, 2017
FDA Product Classification
INGREDIENTS (2)
OXYGENActive
Quantity: 400 mL in 1 L
Code: S88TT14065
Classification: ACTIB
HELIUMInactive
Quantity: 600 mL in 1 L
Code: 206GF3GB41
Classification: IACT