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
f2feda53-54b9-4e40-8a01-9e7b45cb3d8c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 9, 2024
Manufacturers
FDA
Alembic Pharmaceuticals Inc.
DUNS: 079288842
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 Code62332-633
Application NumberANDA214779
Product Classification
M
Marketing Category
C73584
G
Generic Name
Arformoterol tartrate
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateMay 16, 2022
FDA Product Classification
INGREDIENTS (5)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ARFORMOTEROL TARTRATEActive
Quantity: 15 ug in 2 mL
Code: 5P8VJ2I235
Classification: ACTIM
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT