arformoterol tartrate
These highlights do not include all the information needed to use ARFORMOTEROL TARTRATE INHALATION SOLUTION safely and effectively. See full prescribing information for ARFORMOTEROL TARTRATE INHALATION SOLUTION. ARFORMOTEROL TARTRATE inhalation solution Initial U.S. Approval: 2006
Approved
Approval ID
e9eb1ac7-57aa-4ef8-aac3-14def5b883d0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 15, 2023
Manufacturers
FDA
Lifestar Pharma LLC
DUNS: 080268943
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
arformoterol tartrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70756-612
Application NumberANDA216128
Product Classification
M
Marketing Category
C73584
G
Generic Name
arformoterol tartrate
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateMarch 15, 2023
FDA Product Classification
INGREDIENTS (5)
ARFORMOTEROL TARTRATEActive
Quantity: 15 ug in 2 mL
Code: 5P8VJ2I235
Classification: ACTIM
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT