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Generated: April 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065117

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NDA 065117 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-seven 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-five 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 065117
Tradename:AMOXICILLIN AND CLAVULANATE POTASSIUM
Applicant:Sandoz Inc
Ingredient:amoxicillin; clavulanate potassium
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 065117
Ingredient-typePenicillins
Mechanism of Actionbeta Lactamase Inhibitors
Suppliers and Packaging for NDA: 065117
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMOXICILLIN AND CLAVULANATE POTASSIUM amoxicillin; clavulanate potassium TABLET;ORAL 065117 ANDA Northstar RxLLC 16714-494 N 16714-494-01
AMOXICILLIN AND CLAVULANATE POTASSIUM amoxicillin; clavulanate potassium TABLET;ORAL 065117 ANDA Unit Dose Services 50436-6052 N 50436-6052-1

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG;EQ 125MG BASE
Approval Date:Nov 27, 2002TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
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Cipla
Healthtrust
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Covington
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US Army

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