Details for New Drug Application (NDA): 203824

NDA 203824 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-six 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-nine suppliers are listed for this compound. Additional details are available on the amoxicillin; clavulanate potassium profile page.

Summary for 203824

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

Pharmacology for NDA: 203824

Mechanism of Action

beta Lactamase Inhibitors

Suppliers and Packaging for NDA: 203824

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AMOXICILLIN AND CLAVULANATE POTASSIUM	amoxicillin; clavulanate potassium	TABLET;ORAL	203824	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9249	0143-9249-20	20 TABLET in 1 BOTTLE (0143-9249-20)
AMOXICILLIN AND CLAVULANATE POTASSIUM	amoxicillin; clavulanate potassium	TABLET;ORAL	203824	ANDA	medsource pharmaceuticals	45865-980	45865-980-20	20 TABLET in 1 BOTTLE (45865-980-20)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	875MG;EQ 125MG BASE
Approval Date:	Aug 23, 2016	TE:	AB	RLD:	No

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