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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Accenture
US Department of Justice
Johnson and Johnson
Mallinckrodt
Daiichi Sankyo
Healthtrust
McKesson
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Generated: May 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065228

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NDA 065228 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-three suppliers. Additional details are available on the AMOXICILLIN profile page.

The generic ingredient in AMOXICILLIN is amoxicillin; clavulanate potassium. There are forty-five drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the amoxicillin; clavulanate potassium profile page.
Summary for 065228
Tradename:AMOXICILLIN
Applicant:Sandoz
Ingredient:amoxicillin
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 065228
Ingredient-typePenicillins
Medical Subject Heading (MeSH) Categories for 065228
Suppliers and Packaging for NDA: 065228
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMOXICILLIN amoxicillin TABLET;ORAL 065228 ANDA Sandoz Inc 0781-5060 N 0781-5060-01
AMOXICILLIN amoxicillin TABLET;ORAL 065228 ANDA Sandoz Inc 0781-5060 N 0781-5060-20

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Jul 13, 2005TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength875MG
Approval Date:Jul 13, 2005TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
Dow
Argus Health
Colorcon
Healthtrust
Federal Trade Commission
Chinese Patent Office
Baxter
Julphar

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