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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 065324

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NDA 065324 describes AMOXICILLIN, which is a drug marketed by Aurobindo, Chartwell, Hikma Pharms, Labs Atral, Micro Labs, Mylan, Sandoz, Strides Pharma Intl, Sun Pharm Inds Ltd, Teva, Aurobindo Pharma Ltd, Chartwell Rx, Hikma, Ph Health, Apothecon, Aurobindo Pharma, Cipla, Deva Holding As, Micro Labs Ltd India, Sandoz Inc, Apotex Inc, and Teva Pharms Usa, and is included in eighty-five NDAs. It is available from thirty-seven suppliers. Additional details are available on the AMOXICILLIN profile page.

The generic ingredient in AMOXICILLIN is amoxicillin; clavulanate potassium. There are forty-six drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the amoxicillin; clavulanate potassium profile page.

Summary for 065324

Tradename:	AMOXICILLIN
Applicant:	Aurobindo Pharma Ltd
Ingredient:	amoxicillin
Patents:	0

Medical Subject Heading (MeSH) Categories for 065324

Anti-Bacterial Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, FOR SUSPENSION;ORAL			Strength	200MG
Approval Date:	Jan 17, 2007	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, FOR SUSPENSION;ORAL			Strength	400MG
Approval Date:	Jan 17, 2007	TE:		RLD:	No

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