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Generated: December 11, 2018

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Details for New Drug Application (NDA): 065064

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NDA 065064 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-three 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-six suppliers are listed for this compound. Additional details are available on the amoxicillin; clavulanate potassium profile page.
Summary for 065064
Pharmacology for NDA: 065064
Mechanism of Actionbeta Lactamase Inhibitors
Suppliers and Packaging for NDA: 065064
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMOXICILLIN AND CLAVULANATE POTASSIUM amoxicillin; clavulanate potassium TABLET;ORAL 065064 ANDA Sandoz Inc 0781-1831 0781-1831-13 100 TABLET, FILM COATED in 1 BOX, UNIT-DOSE (0781-1831-13)
AMOXICILLIN AND CLAVULANATE POTASSIUM amoxicillin; clavulanate potassium TABLET;ORAL 065064 ANDA Sandoz Inc 0781-1831 0781-1831-20 20 TABLET, FILM COATED in 1 BOTTLE (0781-1831-20)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG;EQ 125MG BASE
Approval Date:Mar 15, 2002TE:ABRLD:No

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