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Generated: December 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065093

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NDA 065093 describes AMOXICILLIN AND CLAVULANATE POTASSIUM, which is a drug marketed by Aurobindo Pharma Ltd, Hikma Pharms, Sandoz, Sandoz Inc, Sun Pharm Inds Ltd, Teva, Wockhardt, Wockhardt Eu Operatn, Apotex Inc, Micro Labs Ltd India, and Teva Pharms Usa, and is included in thirty-three NDAs. It is available from forty-four 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-four drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the amoxicillin; clavulanate potassium profile page.

Summary for 065093

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 065093

Ingredient-typePenicillins
Mechanism of Actionbeta Lactamase Inhibitors

Suppliers and Packaging for NDA: 065093

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMOXICILLIN AND CLAVULANATE POTASSIUM amoxicillin; clavulanate potassium TABLET;ORAL 065093 ANDA Mylan Pharmaceuticals Inc. 0378-0832 0378-0832-01 100 TABLET, FILM COATED in 1 BOTTLE (0378-0832-01)
AMOXICILLIN AND CLAVULANATE POTASSIUM amoxicillin; clavulanate potassium TABLET;ORAL 065093 ANDA Blenheim Pharmacal, Inc. 10544-951 10544-951-06 6 TABLET, FILM COATED in 1 BOTTLE (10544-951-06)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength875MG;EQ 125MG BASE
Approval Date:Nov 21, 2002TE:ABRLD:No


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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