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Serving leading biopharmaceutical companies globally:

Cerilliant
Moodys
Daiichi Sankyo
Dow
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Argus Health
Express Scripts
Healthtrust
Chinese Patent Office
Covington

Generated: December 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065358

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NDA 065358 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 065358

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

Pharmacology for NDA: 065358

Ingredient-typePenicillins
Mechanism of Actionbeta Lactamase Inhibitors

Suppliers and Packaging for NDA: 065358

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMOXICILLIN AND CLAVULANATE POTASSIUM amoxicillin; clavulanate potassium FOR SUSPENSION;ORAL 065358 ANDA Mylan Pharmaceuticals Inc. 0378-0835 0378-0835-75 75 mL in 1 BOTTLE, DISPENSING (0378-0835-75)
AMOXICILLIN AND CLAVULANATE POTASSIUM amoxicillin; clavulanate potassium FOR SUSPENSION;ORAL 065358 ANDA Mylan Pharmaceuticals Inc. 0378-0835 0378-0835-34 125 mL in 1 BOTTLE, DISPENSING (0378-0835-34)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength600MG/5ML;EQ 42.9MG BASE/5ML
Approval Date:Aug 13, 2007TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Deloitte
Covington
Boehringer Ingelheim
Federal Trade Commission
Baxter
Colorcon
US Department of Justice
Merck
Argus Health
Novartis

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