Oxygen Helium Mixture 30/70
O2 30 HE 70 MIX
Approved
Approval ID
60cee881-4199-10bb-e053-2a91aa0afce7
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 30/70
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code10014-018
Application NumberNDA205840
Product Classification
M
Marketing Category
C73594
G
Generic Name
Oxygen Helium Mixture 30/70
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateDecember 18, 2017
FDA Product Classification
INGREDIENTS (2)
OXYGENActive
Quantity: 300 mL in 1 L
Code: S88TT14065
Classification: ACTIB
HELIUMInactive
Quantity: 700 mL in 1 L
Code: 206GF3GB41
Classification: IACT