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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 065344

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NDA 065344 describes AMOXICILLIN, which is a drug marketed by Aurobindo, Chartwell, Hikma Pharms, Labs Atral, Micro Labs, Mylan, Sandoz, Strides Pharma, Sun Pharm Inds Ltd, Teva, Aurobindo Pharma Ltd, Chartwell Rx, Endo Operations, Hikma, 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-five 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-nine suppliers are listed for this compound. Additional details are available on the amoxicillin; clavulanate potassium profile page.

Summary for 065344

Tradename:	AMOXICILLIN
Applicant:	Chartwell Rx
Ingredient:	amoxicillin
Patents:	0

Medical Subject Heading (MeSH) Categories for 065344

Anti-Bacterial Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	875MG
Approval Date:	Jan 15, 2009	TE:		RLD:	No

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