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 one supplier. 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 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

Bone Density Conservation Agents

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	Radius Health, Inc.	70539-400	70539-400-04	4 BLISTER PACK in 1 BOX (70539-400-04) / 1 TABLET, EFFERVESCENT in 1 BLISTER PACK (70539-400-00)
BINOSTO	alendronate sodium	TABLET, EFFERVESCENT;ORAL	202344	NDA	Radius Health, Inc.	70539-400	70539-400-94	4 BLISTER PACK in 1 BOX (70539-400-94) / 1 TABLET, EFFERVESCENT in 1 BLISTER PACK (70539-400-00)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EFFERVESCENT;ORAL			Strength	EQ 70MG BASE
Approval Date:	Mar 12, 2012	TE:		RLD:	Yes
Patent:	9,592,195	Patent Expiration:	Dec 5, 2031	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 202344

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Radius	BINOSTO	alendronate sodium	TABLET, EFFERVESCENT;ORAL	202344-001	Mar 12, 2012	7,488,496	⤷ Get Started Free
Radius	BINOSTO	alendronate sodium	TABLET, EFFERVESCENT;ORAL	202344-001	Mar 12, 2012	7,964,212	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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