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Generated: March 17, 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 Bio Ag, Apotex Inc, Micro Labs Ltd India, and Teva Pharms Usa, and is included in thirty-three NDAs. It is available from forty-six 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. Fifty suppliers are listed for this compound. Additional details are available on the amoxicillin; clavulanate potassium profile page.
Summary for 065109
Applicant:Sun Pharm Inds Ltd
Ingredient:amoxicillin; clavulanate potassium
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 E 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 hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
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Express Scripts

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