Details for New Drug Application (NDA): 204755

NDA 204755 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 204755

Tradename:	AMOXICILLIN AND CLAVULANATE POTASSIUM
Applicant:	Micro Labs Ltd India
Ingredient:	amoxicillin; clavulanate potassium
Patents:	0

Pharmacology for NDA: 204755

Mechanism of Action

beta Lactamase Inhibitors

Suppliers and Packaging for NDA: 204755

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AMOXICILLIN AND CLAVULANATE POTASSIUM	amoxicillin; clavulanate potassium	TABLET;ORAL	204755	ANDA	Micro Labs Limited	42571-162	42571-162-01	100 TABLET, FILM COATED in 1 BOTTLE (42571-162-01)
AMOXICILLIN AND CLAVULANATE POTASSIUM	amoxicillin; clavulanate potassium	TABLET;ORAL	204755	ANDA	Micro Labs Limited	42571-162	42571-162-42	20 TABLET, FILM COATED in 1 BOTTLE (42571-162-42)

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	875MG;EQ 125MG BASE
Approval Date:	Dec 30, 2016	TE:	AB	RLD:	No

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