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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
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Cerilliant
Medtronic
US Department of Justice
Fuji
Express Scripts
Farmers Insurance

Generated: January 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078474

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NDA 078474 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-seven 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-nine suppliers are listed for this compound. Additional details are available on the risperidone profile page.
Summary for 078474
Tradename:RISPERIDONE
Applicant:Sun Pharm Inds Ltd
Ingredient:risperidone
Patents:0
Therapeutic Class:Antipsychotics
Bipolar Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 078474
Medical Subject Heading (MeSH) Categories for 078474
Suppliers and Packaging for NDA: 078474
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RISPERIDONE risperidone TABLET, ORALLY DISINTEGRATING;ORAL 078474 ANDA Ranbaxy Pharmaceuticals Inc. 63304-643 63304-643-69 1 BLISTER PACK in 1 CARTON (63304-643-69) > 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
RISPERIDONE risperidone TABLET, ORALLY DISINTEGRATING;ORAL 078474 ANDA Ranbaxy Pharmaceuticals Inc. 63304-643 63304-643-17 10 POUCH in 1 BOX, UNIT-DOSE (63304-643-17) > 1 TABLET, ORALLY DISINTEGRATING in 1 POUCH (63304-643-11)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength3MG
Approval Date:Aug 6, 2010TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength4MG
Approval Date:Aug 6, 2010TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Chubb
Julphar
Argus Health
AstraZeneca
Novartis
Accenture
Colorcon
Cipla
Harvard Business School

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