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Serving leading biopharmaceutical companies globally:

Fuji
Moodys
US Army
Teva
Accenture
Federal Trade Commission
Argus Health
UBS
Queensland Health
Express Scripts

Generated: January 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076288

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NDA 076288 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 076288
Tradename:RISPERIDONE
Applicant:Mylan
Ingredient:risperidone
Patents:0
Therapeutic Class:Antipsychotics
Bipolar Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 076288
Medical Subject Heading (MeSH) Categories for 076288
Suppliers and Packaging for NDA: 076288
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RISPERIDONE risperidone TABLET;ORAL 076288 ANDA Mylan Pharmaceuticals Inc. 0378-3502 0378-3502-91 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3502-91)
RISPERIDONE risperidone TABLET;ORAL 076288 ANDA Mylan Pharmaceuticals Inc. 0378-3502 0378-3502-05 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3502-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.25MG
Approval Date:Sep 15, 2008TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG
Approval Date:Sep 15, 2008TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Sep 15, 2008TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Baxter
Colorcon
Johnson and Johnson
Healthtrust
Medtronic
Boehringer Ingelheim
QuintilesIMS
Moodys
Accenture

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