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Generated: May 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050564

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NDA 050564 describes AUGMENTIN '500', which is a drug marketed by Dr Reddys Labs Inc and is included in one NDA. It is available from three suppliers. Additional details are available on the AUGMENTIN '500' profile page.

The generic ingredient in AUGMENTIN '500' 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 050564
Tradename:AUGMENTIN '500'
Applicant:Dr Reddys Labs Inc
Ingredient:amoxicillin; clavulanate potassium
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 050564
Ingredient-typePenicillins
Mechanism of Actionbeta Lactamase Inhibitors
Suppliers and Packaging for NDA: 050564
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AUGMENTIN '250' amoxicillin; clavulanate potassium TABLET;ORAL 050564 NDA Dr. Reddy's Laboratories Inc 43598-006 N 43598-006-14
AUGMENTIN '250' amoxicillin; clavulanate potassium TABLET;ORAL 050564 NDA Dr. Reddy's Laboratories Inc 43598-006 N 43598-006-78

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength250MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Aug 6, 1984TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength500MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Aug 6, 1984TE:RLD:Yes

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