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
NDC Product Code46123-109
Application NumberNDA205849
Marketing CategoryC73594
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateNovember 16, 2023
Generic NameAir
INGREDIENTS (2)
NITROGENInactive
Code: N762921K75
Classification: IACT
OXYGENActive
Quantity: 210 mL in 1 L
Code: S88TT14065
Classification: ACTIB