Air
AIR -109
Approved
Approval ID
dfd24dc4-78dd-48a9-944e-64550ab76072
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 16, 2023
Manufacturers
FDA
Roberts Oxygen Company, Inc.
DUNS: 042646877
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Air
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code46123-109
Application NumberNDA205849
Product Classification
M
Marketing Category
C73594
G
Generic Name
Air
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateNovember 16, 2023
FDA Product Classification
INGREDIENTS (2)
NITROGENInactive
Code: N762921K75
Classification: IACT
OXYGENActive
Quantity: 210 mL in 1 L
Code: S88TT14065
Classification: ACTIB