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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Daiichi Sankyo
Chinese Patent Office
Healthtrust
Fish and Richardson
Covington
UBS
Cipla
Merck

Generated: April 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201091

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NDA 201091 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 thirty-four 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. Thirty-seven suppliers are listed for this compound. Additional details are available on the amoxicillin; clavulanate potassium profile page.
Summary for 201091
Tradename:AMOXICILLIN AND CLAVULANATE POTASSIUM
Applicant:Aurobindo Pharma Ltd
Ingredient:amoxicillin; clavulanate potassium
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 201091
Ingredient-typePenicillins
Mechanism of Actionbeta Lactamase Inhibitors
Suppliers and Packaging for NDA: 201091
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMOXICILLIN AND CLAVULANATE POTASSIUM amoxicillin; clavulanate potassium FOR SUSPENSION;ORAL 201091 ANDA NorthStar Rx LLC 16714-294 N 16714-294-03
AMOXICILLIN AND CLAVULANATE POTASSIUM amoxicillin; clavulanate potassium FOR SUSPENSION;ORAL 201091 ANDA NorthStar Rx LLC 16714-294 N 16714-294-02

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength600MG/5ML;EQ 42.9MG BASE/5ML
Approval Date:Dec 20, 2011TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Dow
Medtronic
Covington
Cipla
US Army
Cerilliant
Teva
Daiichi Sankyo
McKinsey

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