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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 065319


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NDA 065319 describes AMOXICILLIN, which is a drug marketed by Aurobindo, Chartwell, Hikma Pharms, Labs Atral, Micro Labs, Mylan, Sandoz, Strides Pharma, Sun Pharm Inds Ltd, Teva, Aurobindo Pharma Ltd, Chartwell Rx, Dava Pharms Inc, Hikma, Wockhardt Bio Ag, Apothecon, Aurobindo Pharma, Deva Holding As, Micro Labs Ltd India, Sandoz Inc, Apotex Inc, and Teva Pharms Usa, and is included in eighty-five NDAs. It is available from thirty-five suppliers. Additional details are available on the AMOXICILLIN profile page.

The generic ingredient in AMOXICILLIN is amoxicillin; clavulanate potassium. There are forty-six drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the amoxicillin; clavulanate potassium profile page.
Summary for 065319
Tradename:AMOXICILLIN
Applicant:Wockhardt Bio Ag
Ingredient:amoxicillin
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 065319

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength400MG/5ML
Approval Date:Jun 18, 2007TE:ABRLD:No

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