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Generated: October 22, 2018

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Details for New Drug Application (NDA): 065066

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NDA 065066 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-two 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. Forty-five suppliers are listed for this compound. Additional details are available on the amoxicillin; clavulanate potassium profile page.
Summary for 065066
Pharmacology for NDA: 065066
Ingredient-typePenicillins
Mechanism of Actionbeta Lactamase Inhibitors
Suppliers and Packaging for NDA: 065066
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMOXICILLIN AND CLAVULANATE POTASSIUM amoxicillin; clavulanate potassium FOR SUSPENSION;ORAL 065066 ANDA Sandoz Inc 0781-6102 0781-6102-46 100 mL in 1 BOTTLE (0781-6102-46)
AMOXICILLIN AND CLAVULANATE POTASSIUM amoxicillin; clavulanate potassium FOR SUSPENSION;ORAL 065066 ANDA Sandoz Inc 0781-6104 0781-6104-46 100 mL in 1 BOTTLE (0781-6104-46)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength200MG/5ML;EQ 28.5MG BASE/5ML
Approval Date:Jun 5, 2002TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength400MG/5ML;EQ 57MG BASE/5ML
Approval Date:Jun 5, 2002TE:ABRLD:No

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