PROAIRHFA
These highlights do not include all the information needed to use PROAIR HFA safely and effectively. See full prescribing information for PROAIR HFA Inhalation Aerosol. PROAIR HFA (albuterol sulfate) INHALATION AEROSOLInitial U.S. Approval: 1981
Approved
Approval ID
22367ff1-5edf-429a-955a-728e42695f60
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 4, 2011
Manufacturers
FDA
H.J. Harkins Company, Inc.
DUNS: 147681894
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
albuterol sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52959-978
Application NumberNDA021457
Product Classification
M
Marketing Category
C73594
G
Generic Name
albuterol sulfate
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateNovember 4, 2011
FDA Product Classification
INGREDIENTS (3)
NORFLURANEInactive
Code: DH9E53K1Y8
Classification: IACT
ALBUTEROL SULFATEActive
Quantity: 90 ug in 1 1
Code: 021SEF3731
Classification: ACTIM
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT