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Boehringer Ingelheim
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Generated: April 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201090

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NDA 201090 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 201090
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: 201090
Ingredient-typePenicillins
Mechanism of Actionbeta Lactamase Inhibitors
Suppliers and Packaging for NDA: 201090
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMOXICILLIN AND CLAVULANATE POTASSIUM amoxicillin; clavulanate potassium FOR SUSPENSION;ORAL 201090 ANDA NorthStar Rx LLC 16714-292 N 16714-292-01
AMOXICILLIN AND CLAVULANATE POTASSIUM amoxicillin; clavulanate potassium FOR SUSPENSION;ORAL 201090 ANDA NorthStar Rx LLC 16714-292 N 16714-292-02

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength200MG/5ML;EQ 28.5MG BASE/5ML
Approval Date:Dec 20, 2011TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength400MG/5ML;EQ 57MG BASE/5ML
Approval Date:Dec 20, 2011TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
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Fuji
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Fish and Richardson
Chinese Patent Office

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