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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 065317

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NDA 065317 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 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-three suppliers are listed for this compound. Additional details are available on the amoxicillin; clavulanate potassium profile page.

Summary for 065317

Tradename:	AMOXICILLIN AND CLAVULANATE POTASSIUM
Applicant:	Apotex Inc
Ingredient:	amoxicillin; clavulanate potassium
Patents:	0

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	875MG;EQ 125MG BASE
Approval Date:	Oct 20, 2008	TE:		RLD:	No

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