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Serving leading biopharmaceutical companies globally:

Colorcon
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Generated: January 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076908

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NDA 076908 describes RISPERIDONE, which is a drug marketed by Amneal Pharms, Ani Pharms Inc, Apotex Inc, Bio Pharm Inc, Lifestar Pharma, Precision Dose, Silarx Pharms Inc, Taro, Tris Pharma Inc, Vintage, West-ward Pharms Int, Wockhardt, Actavis Labs Fl Inc, Dr Reddys Labs Ltd, Jubilant Generics, Mylan Pharms Inc, Par Pharm, Sandoz, Sun Pharm Inds Ltd, Teva, Zydus Pharms Usa, Ajanta Pharma Ltd, Aurobindo Pharma, Cipla, Jubilant Cadista, Mylan, Oxford Pharms, Pliva Hrvatska Doo, Prinston Inc, Ratiopharm, Sun Pharm Inds Inc, Synthon Pharms, Torrent Pharms, Watson Labs, West Ward Pharms, and Zydus Pharms Usa Inc, and is included in forty-four NDAs. It is available from fifty-eight suppliers. Additional details are available on the RISPERIDONE profile page.

The generic ingredient in RISPERIDONE is risperidone. There are thirty drug master file entries for this compound. Sixty suppliers are listed for this compound. Additional details are available on the risperidone profile page.
Summary for 076908
Tradename:RISPERIDONE
Applicant:Teva
Ingredient:risperidone
Patents:0
Therapeutic Class:Antipsychotics
Bipolar Agents
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 076908

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength0.5MG
Approval Date:Mar 12, 2012TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength1MG
Approval Date:Mar 12, 2012TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength2MG
Approval Date:Mar 12, 2012TE:ABRLD:No

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Dow
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QuintilesIMS
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Deloitte
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Chinese Patent Office
Fish and Richardson

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