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Serving hundreds of leading biopharmaceutical companies globally:

Teva
Argus Health
Mallinckrodt
QuintilesIMS
UBS
Citi
Johnson and Johnson
Accenture
Medtronic

Generated: April 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 064013

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NDA 064013 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 thirty-six 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. Thirty-seven suppliers are listed for this compound. Additional details are available on the amoxicillin; clavulanate potassium profile page.
Summary for 064013
Tradename:AMOXICILLIN
Applicant:Teva
Ingredient:amoxicillin
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 064013
Ingredient-typePenicillins
Medical Subject Heading (MeSH) Categories for 064013
Suppliers and Packaging for NDA: 064013
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMOXICILLIN amoxicillin TABLET, CHEWABLE;ORAL 064013 ANDA Teva Pharmaceuticals USA Inc 0093-2267 N 0093-2267-01
AMOXICILLIN amoxicillin TABLET, CHEWABLE;ORAL 064013 ANDA Teva Pharmaceuticals USA Inc 0093-2268 N 0093-2268-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, CHEWABLE;ORALStrength250MG
Approval Date:Dec 22, 1992TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, CHEWABLE;ORALStrength125MG
Approval Date:Sep 11, 1995TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Fuji
Colorcon
AstraZeneca
UBS
Federal Trade Commission
Harvard Business School
Boehringer Ingelheim
US Department of Justice
Express Scripts

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