BioPharmaceutical Business Intelligence

  • Analyze global market entry opportunities
  • Identify first generic entrants
  • Obtain formulation and manufacturing information
➤ Start Trial

or, See Plans & Pricing

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

Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Deloitte
Novartis
US Army
Mallinckrodt
McKinsey
Accenture
US Department of Justice
UBS
Harvard Business School

Generated: January 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090839

« Back to Dashboard

NDA 090839 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 090839
Tradename:RISPERIDONE
Applicant:Jubilant Generics
Ingredient:risperidone
Patents:0
Therapeutic Class:Antipsychotics
Bipolar Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 090839
Medical Subject Heading (MeSH) Categories for 090839
Suppliers and Packaging for NDA: 090839
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RISPERIDONE risperidone TABLET, ORALLY DISINTEGRATING;ORAL 090839 ANDA Jubilant Cadista Pharmaceuticals Inc. 59746-010 59746-010-32 3 BLISTER PACK in 1 CARTON (59746-010-32) > 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
RISPERIDONE risperidone TABLET, ORALLY DISINTEGRATING;ORAL 090839 ANDA Jubilant Cadista Pharmaceuticals Inc. 59746-010 59746-010-22 7 BLISTER PACK in 1 CARTON (59746-010-22) > 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength0.5MG
Approval Date:Nov 4, 2011TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength1MG
Approval Date:Nov 4, 2011TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength2MG
Approval Date:Nov 4, 2011TE:ABRLD:No

Complete Access Available with Subscription

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

Serving leading biopharmaceutical companies globally:

Mallinckrodt
Julphar
Dow
Covington
Daiichi Sankyo
Moodys
Cantor Fitzgerald
AstraZeneca
McKinsey

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.

botpot