Binosto
BINOSTO (alendronate sodium) effervescent tablets for oral solution These highlights do not include all the information needed to use BINOSTO safely and effectively. See full prescribing information for BINOSTO. BINOSTO (alendronate sodium) effervescent tablets for oral solution Initial U.S. Approval: 1995
Approved
Approval ID
b278a11a-b8d7-49f3-9b38-29b67c4c417e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 20, 2023
Manufacturers
FDA
ASCEND Therapeutics
DUNS: 133780051
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
alendronate sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code17139-400
Application NumberNDA202344
Product Classification
M
Marketing Category
C73594
G
Generic Name
alendronate sodium
Product Specifications
Route of AdministrationORAL
Effective DateDecember 20, 2023
FDA Product Classification
INGREDIENTS (7)
ACESULFAME POTASSIUMInactive
Code: 23OV73Q5G9
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
ALENDRONATE SODIUMActive
Quantity: 70 mg in 1 1
Code: 2UY4M2U3RA
Classification: ACTIM
MONOSODIUM CITRATEInactive
Code: 68538UP9SE
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
SODIUM CARBONATEInactive
Code: 45P3261C7T
Classification: IACT