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Queensland Health
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Generated: April 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202167

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Summary for 202167
Tradename:LEVETIRACETAM
Applicant:Dexcel Pharma
Ingredient:levetiracetam
Patents:0
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details
Pharmacology for NDA: 202167
Suppliers and Packaging for NDA: 202167
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVETIRACETAM levetiracetam TABLET, EXTENDED RELEASE;ORAL 202167 ANDA AvKARE, Inc. 42291-387 N 42291-387-60
LEVETIRACETAM levetiracetam TABLET, EXTENDED RELEASE;ORAL 202167 ANDA AvKARE, Inc. 42291-388 N 42291-388-60

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength500MG
Approval Date:Sep 4, 2015TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength750MG
Approval Date:Sep 4, 2015TE:ABRLD:No

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