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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 065132


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NDA 065132 describes AMOXICILLIN AND CLAVULANATE POTASSIUM, which is a drug marketed by Aurobindo Pharma, Aurobindo Pharma Ltd, Cipla, Deva Holding As, Hikma Pharms, Micro Labs, Micro Labs Ltd India, Sandoz, Sandoz Inc, Sun Pharm Inds Ltd, Teva, Chartwell Rx, Apotex Inc, and Teva Pharms Usa, and is included in forty-one NDAs. It is available from thirty-five 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-six drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the amoxicillin; clavulanate potassium profile page.
Summary for 065132

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:FOR SUSPENSION;ORALStrength200MG/5ML;EQ 28.5MG BASE/5ML
Approval Date:Mar 19, 2003TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:FOR SUSPENSION;ORALStrength400MG/5ML;EQ 57MG BASE/5ML
Approval Date:Mar 19, 2003TE:RLD:No

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