Proventil HFA
PROVENTIL® HFA(albuterol sulfate)Inhalation Aerosol
Approved
Approval ID
12d06309-0483-48c6-a9f2-b25dcc31db72
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 4, 2011
Manufacturers
FDA
Rebel Distributors Corp.
DUNS: 118802834
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
NDC Product Code42254-004
Application NumberNDA020503
Marketing CategoryC73594
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateSeptember 8, 2009
Generic NameAlbuterol Sulfate
INGREDIENTS (4)
NorfluraneInactive
Code: DH9E53K1Y8
Classification: IACT
Albuterol SulfateActive
Quantity: 108 ug in 1 1
Code: 021SEF3731
Classification: ACTIB
alcoholInactive
Code: 3K9958V90M
Classification: IACT
Oleic acidInactive
Code: 2UMI9U37CP
Classification: IACT