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Last Updated: September 27, 2020

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Details for New Drug Application (NDA): 205707

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NDA 205707 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-four NDAs. It is available from twenty-seven 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. Twenty-seven suppliers are listed for this compound. Additional details are available on the amoxicillin; clavulanate potassium profile page.
Summary for 205707
Pharmacology for NDA: 205707
Mechanism of Actionbeta Lactamase Inhibitors
Suppliers and Packaging for NDA: 205707
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMOXICILLIN AND CLAVULANATE POTASSIUM amoxicillin; clavulanate potassium TABLET;ORAL 205707 ANDA Micro Labs Limited 42571-160 42571-160-01 100 TABLET, FILM COATED in 1 BOTTLE (42571-160-01)
AMOXICILLIN AND CLAVULANATE POTASSIUM amoxicillin; clavulanate potassium TABLET;ORAL 205707 ANDA Micro Labs Limited 42571-160 42571-160-11 10 BLISTER PACK in 1 CARTON (42571-160-11) > 10 TABLET, FILM COATED in 1 BLISTER PACK (42571-160-32)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG;EQ 125MG BASE
Approval Date:Dec 30, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG;EQ 125MG BASE
Approval Date:Dec 30, 2016TE:ABRLD:No

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