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Serving hundreds of leading biopharmaceutical companies globally:

Generated: April 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 079158

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NDA 079158 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, 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 079158

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

Pharmacology for NDA: 079158

Medical Subject Heading (MeSH) Categories for 079158

Antipsychotic Agents
Dopamine Antagonists
Serotonin Antagonists

Suppliers and Packaging for NDA: 079158

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
RISPERIDONE	risperidone	SOLUTION;ORAL	079158	ANDA	Par Pharmaceutical	0603-9424	N	0603-9424-45

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	1MG/ML
Approval Date:	Dec 3, 2010	TE:	AA	RLD:	No

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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt

Johnson and Johnson

Federal Trade Commission

McKesson

Chubb

US Department of Justice

Baxter

Deloitte

Dow

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