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Serving leading biopharmaceutical companies globally:

Deloitte
Cantor Fitzgerald
Boehringer Ingelheim
Healthtrust
Mallinckrodt
Daiichi Sankyo
Chinese Patent Office
Federal Trade Commission
US Department of Justice
Colorcon

Generated: January 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203987

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NDA 203987 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 203987
Tradename:IBANDRONATE SODIUM
Applicant:Emcure Pharms Ltd
Ingredient:ibandronate sodium
Patents:0
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 203987
Ingredient-typeDiphosphonates
Suppliers and Packaging for NDA: 203987
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IBANDRONATE SODIUM ibandronate sodium INJECTABLE;INTRAVENOUS 203987 ANDA Heritage Pharmaceuticals Inc. 23155-162 23155-162-31 3 mL in 1 VIAL, GLASS (23155-162-31)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrengthEQ 3MG BASE/3ML
Approval Date:Sep 2, 2014TE:APRLD:No

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Serving leading biopharmaceutical companies globally:

Covington
Cerilliant
Express Scripts
Mallinckrodt
QuintilesIMS
UBS
Harvard Business School
Dow
Fuji

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