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US Department of Justice
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Queensland Health
Argus Health
Cantor Fitzgerald

Generated: April 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078941

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NDA 078941 describes ENTACAPONE, which is a drug marketed by Ajanta Pharma Ltd, Aurobindo Pharma Ltd, Macleods Pharms Ltd, Mylan Pharms Inc, Sun Pharma Global, and Wockhardt Ltd, and is included in six NDAs. It is available from eight suppliers. Additional details are available on the ENTACAPONE profile page.

The generic ingredient in ENTACAPONE is entacapone. There are nineteen drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the entacapone profile page.
Summary for 078941
Applicant:Wockhardt Ltd
Therapeutic Class:Antiparkinson Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 078941
Suppliers and Packaging for NDA: 078941
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ENTACAPONE entacapone TABLET;ORAL 078941 ANDA Wockhardt Limited 55648-711 N 55648-711-02
ENTACAPONE entacapone TABLET;ORAL 078941 ANDA Wockhardt Limited 55648-711 N 55648-711-03

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Aug 16, 2012TE:ABRLD:No

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