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Last Updated: July 14, 2020

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Details for New Drug Application (NDA): 202344


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NDA 202344 describes BINOSTO, which is a drug marketed by Ascend Theraps Us and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the BINOSTO profile page.

The generic ingredient in BINOSTO is alendronate sodium. There are twenty-five drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the alendronate sodium profile page.
Summary for 202344
Tradename:BINOSTO
Applicant:Ascend Theraps Us
Ingredient:alendronate sodium
Patents:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 202344
Medical Subject Heading (MeSH) Categories for 202344
Suppliers and Packaging for NDA: 202344
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BINOSTO alendronate sodium TABLET, EFFERVESCENT;ORAL 202344 NDA ASCEND Therapeutics 17139-400 17139-400-01 1 TABLET, EFFERVESCENT in 1 CARTON (17139-400-01)
BINOSTO alendronate sodium TABLET, EFFERVESCENT;ORAL 202344 NDA ASCEND Therapeutics 17139-400 17139-400-04 4 TABLET, EFFERVESCENT in 1 CARTON (17139-400-04)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EFFERVESCENT;ORALStrengthEQ 70MG BASE
Approval Date:Mar 12, 2012TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Aug 11, 2023Product Flag?YSubstance Flag?YDelist Request?
Patent:  Start TrialPatent Expiration:Mar 6, 2023Product Flag?YSubstance Flag?YDelist Request?

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Harvard Business School
Johnson and Johnson
Express Scripts
Medtronic
McKesson

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