Details for New Drug Application (NDA): 065189

NDA 065189 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-five 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-eight suppliers are listed for this compound. Additional details are available on the amoxicillin; clavulanate potassium profile page.

Summary for 065189

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

Pharmacology for NDA: 065189

Mechanism of Action

beta Lactamase Inhibitors

Suppliers and Packaging for NDA: 065189

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AMOXICILLIN AND CLAVULANATE POTASSIUM	amoxicillin; clavulanate potassium	TABLET;ORAL	065189	ANDA	Sandoz Inc	0781-1874	0781-1874-31	30 TABLET, FILM COATED in 1 BOTTLE (0781-1874-31)
AMOXICILLIN AND CLAVULANATE POTASSIUM	amoxicillin; clavulanate potassium	TABLET;ORAL	065189	ANDA	Northstar RxLLC	16714-476	16714-476-01	30 TABLET, FILM COATED in 1 BOTTLE (16714-476-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	250MG;EQ 125MG BASE
Approval Date:	Aug 23, 2005	TE:	AB	RLD:	No

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