Levalbuterol tartrate HFA inhalation
These highlights do not include all the information needed to use Levalbuterol tartrate HFA inhalation aerosol safely and effectively. See full prescribing information for Levalbuterol tartrate HFA inhalation aerosol. Levalbuterol tartrate HFA inhalation aerosol, for oral inhalation use Initial U.S. Approval: 1999
Approved
Approval ID
ac85703a-17a2-4f0b-87f4-78f1756d2f85
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 1, 2023
Manufacturers
FDA
Actavis Pharma, Inc.
DUNS: 119723554
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
levalbuterol tartrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0591-2927
Application NumberNDA021730
Product Classification
M
Marketing Category
C73605
G
Generic Name
levalbuterol tartrate
Product Specifications
Route of AdministrationORAL
Effective DateJuly 1, 2023
FDA Product Classification
INGREDIENTS (4)
LEVALBUTEROL TARTRATEActive
Quantity: 45 ug in 1 1
Code: ADS4I3E22M
Classification: ACTIM
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
NORFLURANEInactive
Code: DH9E53K1Y8
Classification: IACT
OLEIC ACIDInactive
Code: 2UMI9U37CP
Classification: IACT