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Colorcon
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Accenture
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Baxter
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Generated: June 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050755

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NDA 050755 describes AUGMENTIN ES-600, which is a drug marketed by Dr Reddys Labs Inc and is included in one NDA. It is available from four suppliers. Additional details are available on the AUGMENTIN ES-600 profile page.

The generic ingredient in AUGMENTIN ES-600 is amoxicillin; clavulanate potassium. There are forty-five 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 050755
Tradename:AUGMENTIN ES-600
Applicant:Dr Reddys Labs Inc
Ingredient:amoxicillin; clavulanate potassium
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 050755
Ingredient-typePenicillins
Mechanism of Actionbeta Lactamase Inhibitors
Suppliers and Packaging for NDA: 050755
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AUGMENTIN ES-600 amoxicillin; clavulanate potassium FOR SUSPENSION;ORAL 050755 NDA Aidarex Pharmaceuticals LLC 33261-600 N 33261-600-01
AUGMENTIN ES-600 amoxicillin; clavulanate potassium FOR SUSPENSION;ORAL 050755 NDA Aidarex Pharmaceuticals LLC 33261-970 N 33261-970-01

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:FOR SUSPENSION;ORALStrength600MG/5ML;EQ 42.9MG BASE/5ML
Approval Date:Jun 22, 2001TE:RLD:Yes

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Serving hundreds of leading biopharmaceutical companies globally:

Citi
Daiichi Sankyo
McKinsey
Cipla
Medtronic
McKesson
Fuji
US Department of Justice
Express Scripts

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