Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Cipla
Daiichi Sankyo
Healthtrust
Colorcon
Citi
Covington
Express Scripts
Boehringer Ingelheim

Generated: June 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078744

« Back to Dashboard

NDA 078744 describes RISPERIDONE, which is a drug marketed by Amneal Pharms, Ani Pharms Inc, Apotex Inc, Bio Pharm Inc, Lannett Co Inc, Lifestar Pharma, 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 078744
Tradename:RISPERIDONE
Applicant:Wockhardt
Ingredient:risperidone
Patents:0
Therapeutic Class:Antipsychotics
Bipolar Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 078744
Medical Subject Heading (MeSH) Categories for 078744
Suppliers and Packaging for NDA: 078744
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RISPERIDONE risperidone SOLUTION;ORAL 078744 ANDA WOCKHARDT LIMITED 55648-692 E 55648-692-01
RISPERIDONE risperidone SOLUTION;ORAL 078744 ANDA WOCKHARDT USA LLC. 64679-692 E 64679-692-01

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;ORALStrength1MG/ML
Approval Date:Oct 8, 2009TE:RLD:No

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

US Army
Cerilliant
Johnson and Johnson
Dow
Federal Trade Commission
Healthtrust
Teva
Chinese Patent Office
Express Scripts

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.