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Details for New Drug Application (NDA): 065333

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NDA 065333 describes AMOXICILLIN AND CLAVULANATE POTASSIUM, which is a drug marketed by Teva, Sun Pharm Inds Ltd, Apotex Inc, Sandoz Inc, Wockhardt Eu Operatn, Hikma Pharms, Sandoz, Wockhardt, Aurobindo Pharma Ltd, and Teva Pharms Usa, and is included in thirty-one NDAs. It is available from thirty-nine suppliers. Additional details are available on the AMOXICILLIN AND CLAVULANATE POTASSIUM profile page.

The generic ingredient in AMOXICILLIN AND CLAVULANATE POTASSIUM is amoxicillin; clavulanate potassium. There are forty-three drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the amoxicillin; clavulanate potassium profile page.

Summary for NDA: 065333

Tradename:
AMOXICILLIN AND CLAVULANATE POTASSIUM
Applicant:
Apotex Inc
Ingredient:
amoxicillin; clavulanate potassium
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength250MG;EQ 125MG BASE
Approval Date:Feb 24, 2009TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength500MG;EQ 125MG BASE
Approval Date:Feb 24, 2009TE:RLD:No


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