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Fish and Richardson
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US Department of Justice
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Generated: May 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091399

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Summary for 091399
Tradename:LEVETIRACETAM
Applicant:Lupin Ltd
Ingredient:levetiracetam
Patents:0
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details
Pharmacology for NDA: 091399
Suppliers and Packaging for NDA: 091399
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVETIRACETAM levetiracetam TABLET, EXTENDED RELEASE;ORAL 091399 ANDA LUPIN LIMITED 57297-117 E 57297-117-02
LEVETIRACETAM levetiracetam TABLET, EXTENDED RELEASE;ORAL 091399 ANDA LUPIN LIMITED 57297-117 E 57297-117-07

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength500MG
Approval Date:Sep 12, 2011TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength750MG
Approval Date:Sep 12, 2011TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
Farmers Insurance
AstraZeneca
Cantor Fitzgerald
Julphar
Fuji
QuintilesIMS
Harvard Business School
Healthtrust

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