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Last Updated: January 17, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021858

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NDA 021858 describes BONIVA, which is a drug marketed by Roche and Hoffmann La Roche and is included in two NDAs. It is available from one supplier. There are three patents protecting this drug and two Paragraph IV challenges. 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. Eleven suppliers are listed for this compound. Additional details are available on the ibandronate sodium profile page.
Summary for 021858
Ingredient:ibandronate sodium
Formulation / Manufacturing:see details
Pharmacology for NDA: 021858
Suppliers and Packaging for NDA: 021858
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BONIVA ibandronate sodium INJECTABLE;INTRAVENOUS 021858 NDA Genentech, Inc. 0004-0191 0004-0191-09 1 SYRINGE, GLASS in 1 CARTON (0004-0191-09) > 3 mL in 1 SYRINGE, GLASS
Paragraph IV (Patent) Challenges for 021858
Tradename Dosage Ingredient NDA Submissiondate
BONIVA INJECTABLE;INTRAVENOUS ibandronate sodium 021858 2007-08-31

Profile for product number 001

Approval Date:Jan 6, 2006TE:RLD:Yes

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Serving leading biopharmaceutical companies globally:

Harvard Business School
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