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Details for New Drug Application (NDA): 065161

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NDA 065161 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: 065161

Tradename:
AMOXICILLIN AND CLAVULANATE POTASSIUM
Applicant:
Sun Pharm Inds Ltd
Ingredient:
amoxicillin; clavulanate potassium
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 065161

Mechanism of Actionbeta Lactamase Inhibitors

Suppliers and Packaging for NDA: 065161

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMOXICILLIN AND CLAVULANATE POTASSIUM
amoxicillin; clavulanate potassium
TABLET, CHEWABLE;ORAL 065161 ANDA Physicians Total Care, Inc. 54868-0286 54868-0286-0 20 TABLET, CHEWABLE in 1 BOTTLE (54868-0286-0)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, CHEWABLE;ORALStrength200MG;EQ 28.5MG BASE
Approval Date:Dec 3, 2003TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, CHEWABLE;ORALStrength400MG;EQ 57MG BASE
Approval Date:Dec 3, 2003TE:RLD:No


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