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Last Updated: December 29, 2025

Details for New Drug Application (NDA): 065255

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NDA 065255 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 065255

Tradename:	AMOXICILLIN
Applicant:	Hikma
Ingredient:	amoxicillin
Patents:	0

Pharmacology for NDA: 065255

Medical Subject Heading (MeSH) Categories for 065255

Anti-Bacterial Agents

Suppliers and Packaging for NDA: 065255

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AMOXICILLIN	amoxicillin	TABLET;ORAL	065255	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9285	0143-9285-01	100 TABLET, COATED in 1 BOTTLE (0143-9285-01)
AMOXICILLIN	amoxicillin	TABLET;ORAL	065255	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9285	0143-9285-20	20 TABLET, COATED in 1 BOTTLE (0143-9285-20)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	875MG
Approval Date:	Mar 29, 2006	TE:	AB	RLD:	No

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