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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Queensland Health
Federal Trade Commission
Fish and Richardson
Daiichi Sankyo
Harvard Business School

Generated: March 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204030

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NDA 204030 describes AMOXICILLIN, which is a drug marketed by Am Antibiotics, Aurobindo, Dava Pharms Inc, Hikma Pharms, Labs Atral, Mylan, Sandoz, Sun Pharm Inds Ltd, Teva, Aurobindo Pharma Ltd, Hikma, Wockhardt Bio Ag, Apothecon, Sandoz Inc, Apotex Inc, Micro Labs Ltd India, and Teva Pharms Usa, and is included in seventy-five NDAs. It is available from fifty-five suppliers. Additional details are available on the AMOXICILLIN profile page.

The generic ingredient in AMOXICILLIN 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 204030
Applicant:Aurobindo Pharma Ltd
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 204030
Medical Subject Heading (MeSH) Categories for 204030
Suppliers and Packaging for NDA: 204030
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMOXICILLIN amoxicillin FOR SUSPENSION;ORAL 204030 ANDA Aurobindo Pharma Limited 65862-706 N 65862-706-80
AMOXICILLIN amoxicillin FOR SUSPENSION;ORAL 204030 ANDA Aurobindo Pharma Limited 65862-706 N 65862-706-55

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength125MG/5ML
Approval Date:Sep 15, 2014TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength250MG/5ML
Approval Date:Sep 15, 2014TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
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