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Generated: April 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078871

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NDA 078871 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, 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 forty-five 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. Forty-seven suppliers are listed for this compound. Additional details are available on the risperidone profile page.
Summary for 078871
Tradename:RISPERIDONE
Applicant:Wockhardt
Ingredient:risperidone
Patents:0
Therapeutic Class:Antipsychotics
Bipolar Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 078871
Medical Subject Heading (MeSH) Categories for 078871
Suppliers and Packaging for NDA: 078871
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RISPERIDONE risperidone TABLET;ORAL 078871 ANDA DOH CENTRAL PHARMACY 53808-0565 N 53808-0565-1
RISPERIDONE risperidone TABLET;ORAL 078871 ANDA WOCKHARDT LIMITED 55648-553 N 55648-553-04

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.25MG
Approval Date:Oct 9, 2008TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG
Approval Date:Oct 9, 2008TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Oct 9, 2008TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

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