BioPharmaceutical Business Intelligence

  • Analyze global market entry opportunities
  • Identify first generic entrants
  • Drug patents in 130+ countries
➤ Start Trial

or, See Plans & Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Mallinckrodt
Boehringer Ingelheim
AstraZeneca
Novartis
US Department of Justice
Colorcon
Healthtrust
Cantor Fitzgerald
Dow
Cipla

Generated: January 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065373

« Back to Dashboard

NDA 065373 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-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-four drug master file entries for this compound. Fifty suppliers are listed for this compound. Additional details are available on the amoxicillin; clavulanate potassium profile page.
Summary for 065373
Tradename:AMOXICILLIN AND CLAVULANATE POTASSIUM
Applicant:Hikma Pharms
Ingredient:amoxicillin; clavulanate potassium
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 065373
Ingredient-typePenicillins
Mechanism of Actionbeta Lactamase Inhibitors
Suppliers and Packaging for NDA: 065373
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMOXICILLIN AND CLAVULANATE POTASSIUM amoxicillin; clavulanate potassium FOR SUSPENSION;ORAL 065373 ANDA West-ward Pharmaceutical Corp 0143-9853 0143-9853-75 75 mL in 1 BOTTLE (0143-9853-75)
AMOXICILLIN AND CLAVULANATE POTASSIUM amoxicillin; clavulanate potassium FOR SUSPENSION;ORAL 065373 ANDA West-ward Pharmaceutical Corp 0143-9853 0143-9853-24 200 mL in 1 BOTTLE (0143-9853-24)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength600MG/5ML;EQ 42.9MG BASE/5ML
Approval Date:Nov 9, 2007TE:ABRLD:No

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

Accenture
Dow
Teva
Julphar
Covington
Mallinckrodt
Chubb
Fish and Richardson
QuintilesIMS

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.

botpot