Details for New Drug Application (NDA): 021455

✉ Email this page to a colleague

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DISCN	Dosage:	TABLET;ORAL			Strength	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons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DISCN	Dosage:	TABLET;ORAL			Strength	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons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

Subscribe to access the full database, or Sign Up
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	⤷ Sign Up	⤷ Sign Up
Hoffmann La Roche	BONIVA	ibandronate sodium	TABLET;ORAL	021455-001	May 16, 2003	⤷ Sign Up	⤷ Sign Up
Hoffmann La Roche	BONIVA	ibandronate sodium	TABLET;ORAL	021455-002	Mar 24, 2005	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.