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QuintilesIMS
Dow
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Cipla
Healthtrust
Moodys
Fish and Richardson
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Generated: April 27, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065334

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NDA 065334 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 065334
Tradename:AMOXICILLIN
Applicant:Aurobindo
Ingredient:amoxicillin
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 065334
Ingredient-typePenicillins
Medical Subject Heading (MeSH) Categories for 065334
Suppliers and Packaging for NDA: 065334
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMOXICILLIN amoxicillin FOR SUSPENSION;ORAL 065334 ANDA Rebel Distributors Corp. 21695-294 E 21695-294-00
AMOXICILLIN amoxicillin FOR SUSPENSION;ORAL 065334 ANDA Aidarex Pharmaceuticals LLC 33261-463 N 33261-463-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength200MG/5ML
Approval Date:Dec 28, 2006TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength400MG/5ML
Approval Date:Dec 28, 2006TE:ABRLD:No

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