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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 202344


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NDA 202344 describes BINOSTO, which is a drug marketed by Radius and is included in one NDA. It is available from two suppliers. There is one patent 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. Twenty-two suppliers are listed for this compound. Additional details are available on the alendronate sodium profile page.
Summary for 202344
Tradename:BINOSTO
Applicant:Radius
Ingredient:alendronate sodium
Patents:1
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:⤷  Sign UpPatent Expiration:Dec 5, 2031Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 202344

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Radius BINOSTO alendronate sodium TABLET, EFFERVESCENT;ORAL 202344-001 Mar 12, 2012 ⤷  Sign Up ⤷  Sign Up
Radius BINOSTO alendronate sodium TABLET, EFFERVESCENT;ORAL 202344-001 Mar 12, 2012 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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