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Serving 500+ biopharmaceutical companies globally:

QuintilesIMS
Fish and Richardson
Queensland Health
Federal Trade Commission
Harvard Business School
Covington
Dow
Accenture
US Army
Novartis

Generated: August 20, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078948

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NDA 078948 describes IBANDRONATE SODIUM, which is a drug marketed by Aurobindo Pharma Ltd, Watson Labs Teva, Apotex Inc, Sagent Pharms, Sun Pharm Inds Ltd, Accord Hlthcare, Mylan Labs Ltd, Emcure Pharms Ltd, Mylan Pharms Inc, Sun Pharm Inds, Dr Reddys Labs Ltd, and Orchid Hlthcare, and is included in fourteen NDAs. It is available from twelve 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. Fourteen suppliers are listed for this compound. Additional details are available on the ibandronate sodium profile page.

Summary for NDA: 078948

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 078948

Ingredient-typeDiphosphonates

Suppliers and Packaging for NDA: 078948

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IBANDRONATE SODIUM
ibandronate sodium
TABLET;ORAL 078948 ANDA Golden State Medical Supply, Inc. 60429-643 60429-643-73 3 BLISTER PACK in 1 PACKAGE (60429-643-73) > 1 TABLET, FILM COATED in 1 BLISTER PACK
IBANDRONATE SODIUM
ibandronate sodium
TABLET;ORAL 078948 ANDA Apotex Corp 60505-2795 60505-2795-0 3 BLISTER PACK in 1 PACKAGE (60505-2795-0) > 1 TABLET, FILM COATED in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 150MG BASE
Approval Date:Mar 19, 2012TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

Farmers Insurance
Daiichi Sankyo
Healthtrust
Mallinckrodt
QuintilesIMS
McKesson
Teva
UBS
US Army
Medtronic

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 verifification 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.

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