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Serving leading biopharmaceutical companies globally:

QuintilesIMS
Chinese Patent Office
Baxter
Teva
Mallinckrodt
Deloitte
Colorcon
Covington
Queensland Health
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Generated: January 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065109

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NDA 065109 describes AMOXICILLIN AND CLAVULANATE POTASSIUM, which is a drug marketed by Aurobindo Pharma Ltd, Hikma Pharms, Sandoz, Sandoz Inc, Sun Pharm Inds Ltd, Teva, Wockhardt, Wockhardt Eu Operatn, Apotex Inc, Micro Labs Ltd India, and Teva Pharms Usa, and is included in thirty-three NDAs. It is available from forty-five suppliers. Additional details are available on the AMOXICILLIN AND CLAVULANATE POTASSIUM profile page.

The generic ingredient in AMOXICILLIN AND CLAVULANATE POTASSIUM is amoxicillin; clavulanate potassium. There are forty-four drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the amoxicillin; clavulanate potassium profile page.
Summary for 065109
Tradename:AMOXICILLIN AND CLAVULANATE POTASSIUM
Applicant:Sun Pharm Inds Ltd
Ingredient:amoxicillin; clavulanate potassium
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 065109
Mechanism of Actionbeta Lactamase Inhibitors
Suppliers and Packaging for NDA: 065109
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMOXICILLIN AND CLAVULANATE POTASSIUM amoxicillin; clavulanate potassium TABLET;ORAL 065109 ANDA RedPharm Drug Inc. 67296-0716 67296-0716-1 14 TABLET, FILM COATED in 1 BOTTLE (67296-0716-1)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength500MG;EQ 125MG BASE
Approval Date:Nov 4, 2002TE:RLD:No

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Serving leading biopharmaceutical companies globally:

US Department of Justice
Boehringer Ingelheim
Healthtrust
Harvard Business School
Cerilliant
AstraZeneca
Colorcon
Fish and Richardson
Argus Health

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