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Generated: October 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078828

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NDA 078828 describes RISPERIDONE, which is a drug marketed by Amneal Pharms, Ani Pharms Inc, Apotex Inc, Aurobindo Pharma Ltd, Bio Pharm Inc, Lannett Co Inc, Precision Dose, Taro, Tris Pharma Inc, 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, Chartwell Molecular, Jubilant Cadista, Mylan, Oxford Pharms, Pliva Hrvatska Doo, Prinston Inc, Ratiopharm, Renata, 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-four 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. Fifty-six suppliers are listed for this compound. Additional details are available on the risperidone profile page.
Summary for 078828
Tradename:RISPERIDONE
Applicant:Jubilant Cadista
Ingredient:risperidone
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 078828

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength0.25MG
Approval Date:Mar 23, 2009TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength0.5MG
Approval Date:Mar 23, 2009TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength1MG
Approval Date:Mar 23, 2009TE:RLD:No

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