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Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
US Army
Harvard Business School
Teva
QuintilesIMS
Baxter
Farmers Insurance
Express Scripts
Dow

Generated: April 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065119

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NDA 065119 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-five 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 065119
Tradename:AMOXICILLIN
Applicant:Teva
Ingredient:amoxicillin
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 065119
Ingredient-typePenicillins
Medical Subject Heading (MeSH) Categories for 065119
Suppliers and Packaging for NDA: 065119
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMOXICILLIN amoxicillin FOR SUSPENSION;ORAL 065119 ANDA Teva Pharmaceuticals USA Inc 0093-4160 N 0093-4160-73
AMOXICILLIN amoxicillin FOR SUSPENSION;ORAL 065119 ANDA Teva Pharmaceuticals USA Inc 0093-4160 N 0093-4160-76

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength200MG/5ML
Approval Date:Dec 4, 2002TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength400MG/5ML
Approval Date:Dec 4, 2002TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
US Department of Justice
Cerilliant
Medtronic
Queensland Health
Farmers Insurance
Fuji
Boehringer Ingelheim
Julphar

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