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 SolutionInitial U.S. Approval: 2006.
Approved
Approval ID
cf1f2d1b-0455-4113-9647-507faf49fdd0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 14, 2023
Manufacturers
FDA
Lupin Pharmaceuticals, Inc.
DUNS: 089153071
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 Code70748-175
Application NumberANDA213068
Product Classification
M
Marketing Category
C73584
G
Generic Name
Arformoterol tartrate
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateDecember 14, 2023
FDA Product Classification
INGREDIENTS (5)
ARFORMOTEROL TARTRATEActive
Quantity: 15 ug in 2 mL
Code: 5P8VJ2I235
Classification: ACTIM
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT