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BioPharmaceutical Business Intelligence

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  • Identify first generic entrants
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Serving leading biopharmaceutical companies globally:

Queensland Health
US Army
Moodys
UBS
Boehringer Ingelheim
Dow
Covington
Baxter
Cipla
McKinsey

Generated: December 15, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076228

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NDA 076228 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-six 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-eight suppliers are listed for this compound. Additional details are available on the risperidone profile page.

Summary for 076228

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Antipsychotics
Bipolar Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 076228

Medical Subject Heading (MeSH) Categories for 076228

Suppliers and Packaging for NDA: 076228

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RISPERIDONE risperidone TABLET;ORAL 076228 ANDA State of Florida DOH Central Pharmacy 53808-0310 53808-0310-1 30 TABLET, FILM COATED in 1 BLISTER PACK (53808-0310-1)
RISPERIDONE risperidone TABLET;ORAL 076228 ANDA Contract Pharmacy Services-PA 67046-640 67046-640-30 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-640-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.25MG
Approval Date:Jun 30, 2008TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG
Approval Date:Jun 30, 2008TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Jun 30, 2008TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Argus Health
US Army
Chubb
Queensland Health
UBS
Moodys
Daiichi Sankyo
Farmers Insurance
Cantor Fitzgerald
Chinese Patent Office

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