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Details for New Drug Application (NDA): 021858

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NDA 021858 describes BONIVA, which is a drug marketed by Hoffmann La Roche and Roche and is included in two NDAs. It is available from two suppliers. There are five 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. Fifteen suppliers are listed for this compound. There are two tentative approvals for this compound. Additional details are available on the ibandronate sodium profile page.

Summary for NDA: 021858

Tradename:
BONIVA
Applicant:
Roche
Ingredient:
ibandronate sodium
Patents:0
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 021858

Ingredient-typeDiphosphonates

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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrengthEQ 3MG BASE/3ML
Approval Date:Jan 6, 2006TE:APRLD:Yes

Expired Orange Book Patents for NDA: 021858

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Roche
BONIVA
ibandronate sodium
INJECTABLE;INTRAVENOUS021858-001Jan 6, 20064,927,814► subscribe
Roche
BONIVA
ibandronate sodium
INJECTABLE;INTRAVENOUS021858-001Jan 6, 20065,662,918► subscribe
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