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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Cantor Fitzgerald
Medtronic
Harvard Business School
Moodys
Fish and Richardson
Mallinckrodt
Chinese Patent Office
Express Scripts

Generated: April 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078997

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NDA 078997 describes IBANDRONATE SODIUM, which is a drug marketed by Accord Hlthcare, Apotex Inc, Aurobindo Pharma Ltd, Emcure Pharms Ltd, Mylan Labs Ltd, Sagent Pharms, Sun Pharm Inds Ltd, Dr Reddys Labs Ltd, Macleods Pharms Ltd, Mylan Pharms Inc, Orchid Hlthcare, Sun Pharm Industries, and Watson Labs Teva, and is included in fifteen NDAs. It is available from thirteen suppliers. Additional details are available on the IBANDRONATE SODIUM profile page.

The generic ingredient in IBANDRONATE SODIUM is ibandronate sodium. There are sixteen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the ibandronate sodium profile page.
Summary for 078997
Tradename:IBANDRONATE SODIUM
Applicant:Dr Reddys Labs Ltd
Ingredient:ibandronate sodium
Patents:0
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 078997
Ingredient-typeDiphosphonates
Suppliers and Packaging for NDA: 078997
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IBANDRONATE SODIUM ibandronate sodium TABLET;ORAL 078997 ANDA Dr. Reddy's Laboratories Limited 55111-575 N 55111-575-03

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 150MG BASE
Approval Date:Apr 30, 2012TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
AstraZeneca
Dow
Colorcon
Moodys
Deloitte
Cerilliant
Farmers Insurance
Harvard Business School

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