Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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US Department of Justice
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Generated: August 26, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065191

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NDA 065191 describes AMOXICILLIN AND CLAVULANATE POTASSIUM, which is a drug marketed by Aurobindo Pharma Ltd, Hikma Pharms, Sandoz, Sandoz Inc, Sun Pharm Inds Ltd, Teva, Wockhardt Bio Ag, Apotex Inc, Micro Labs Ltd India, and Teva Pharms Usa, and is included in thirty-four NDAs. It is available from forty-three 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-six drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the amoxicillin; clavulanate potassium profile page.
Summary for 065191
Pharmacology for NDA: 065191
Mechanism of Actionbeta Lactamase Inhibitors
Suppliers and Packaging for NDA: 065191
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMOXICILLIN AND CLAVULANATE POTASSIUM amoxicillin; clavulanate potassium FOR SUSPENSION;ORAL 065191 ANDA West-Ward Pharmaceuticals Corp 0143-9981 0143-9981-01 100 mL in 1 BOTTLE (0143-9981-01)
AMOXICILLIN AND CLAVULANATE POTASSIUM amoxicillin; clavulanate potassium FOR SUSPENSION;ORAL 065191 ANDA West-Ward Pharmaceuticals Corp 0143-9981 0143-9981-50 50 mL in 1 BOTTLE (0143-9981-50)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength400MG/5ML;EQ 57MG BASE/5ML
Approval Date:Jan 25, 2005TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength200MG/5ML;EQ 28.5MG BASE/5ML
Approval Date:Jan 25, 2005TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
Teva
US Department of Justice
Express Scripts
McKinsey
Julphar

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