Binosto
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
09765234-01bc-40f7-b9bb-c167056f3909
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 16, 2023
Manufacturers
FDA
Radius Health, Inc.
DUNS: 146676262
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 Code70539-400
Application NumberNDA202344
Product Classification
M
Marketing Category
C73594
G
Generic Name
alendronate sodium
Product Specifications
Route of AdministrationORAL
Effective DateOctober 22, 2023
FDA Product Classification
INGREDIENTS (6)
ANHYDROUS CITRIC ACIDInactive
Quantity: 839.63 mg in 1 1
Code: XF417D3PSL
Classification: IACT
MONOSODIUM CITRATEInactive
Quantity: 1900 mg in 1 1
Code: 68538UP9SE
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALENDRONATE SODIUMActive
Quantity: 91.37 mg in 1 1
Code: 2UY4M2U3RA
Classification: ACTIM
SODIUM BICARBONATEInactive
Quantity: 751 mg in 1 1
Code: 8MDF5V39QO
Classification: IACT
SODIUM CARBONATEInactive
Quantity: 430 mg in 1 1
Code: 45P3261C7T
Classification: IACT