Binosto

Basic Information

Product Name

Binosto

FDA Product Code

0178-0101

Regulatory Information

NDC Product Code

0178-0101

Application Number

NDA202344

Marketing Category

C73594

Effective Date

October 22, 2018

Territorial Authority

USA

FDA Title

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

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

MONOSODIUM CITRATE

Code: 68538UP9SE

Class Code: IACT

SODIUM BICARBONATE

Code: 8MDF5V39QO

Class Code: IACT

SODIUM CARBONATE

Code: 45P3261C7T

Class Code: IACT

SUCRALOSE

Code: 96K6UQ3ZD4

Class Code: IACT

ANHYDROUS CITRIC ACID

Code: XF417D3PSL

Class Code: IACT

ACESULFAME POTASSIUM

Code: 23OV73Q5G9

Class Code: IACT

ALENDRONATE SODIUM

Quantity: 70 mg in 1 1

Code: 2UY4M2U3RA

Class Code: ACTIM

Active Moieties

ALENDRONIC ACID

Code: X1J18R4W8P

Basic Information

Regulatory Information

Company Information

Active Ingredients

MONOSODIUM CITRATE

SODIUM BICARBONATE

SODIUM CARBONATE

SUCRALOSE

ANHYDROUS CITRIC ACID

ACESULFAME POTASSIUM

Active Moieties

ALENDRONIC ACID