Details for New Drug Application (NDA): 021455

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NDA 021455 describes BONIVA, which is a drug marketed by Roche and Hoffmann La Roche and is included in two NDAs. Additional details are available on the BONIVA profile page.

The generic ingredient in BONIVA is ibandronate sodium. There are sixteen drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the ibandronate sodium profile page.

Summary for 021455

Tradename:	BONIVA
Applicant:	Hoffmann La Roche
Ingredient:	ibandronate sodium
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	May 16, 2003	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Mar 24, 2005	TE:		RLD:	Yes

Expired US Patents for NDA 021455

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Hoffmann La Roche	BONIVA	ibandronate sodium	TABLET;ORAL	021455-002	Mar 24, 2005	6,294,196	⤷ Subscribe
Hoffmann La Roche	BONIVA	ibandronate sodium	TABLET;ORAL	021455-001	May 16, 2003	4,927,814	⤷ Subscribe
Hoffmann La Roche	BONIVA	ibandronate sodium	TABLET;ORAL	021455-002	Mar 24, 2005	7,410,957	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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