You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 11, 2025

Details for New Drug Application (NDA): 091537

✉ Email this page to a colleague

« Back to Dashboard

NDA 091537 describes RISPERIDONE, which is a drug marketed by Amneal, Nanomi, Teva Pharms Usa Inc, Amneal Pharms, Ani Pharms, Apozeal Pharms, Aurobindo Pharma Ltd, Chartwell Molecular, Hikma, Lannett Co Inc, Pharm Assoc, Precision Dose, Sun Pharma Canada, Tris Pharma Inc, Wockhardt Bio Ag, Actavis Labs Fl Inc, Anda Repository, Chartwell Rx, Dash Pharms, Jubilant Generics, Ph Health, Sandoz, Sun Pharm Inds Ltd, Zydus Pharms Usa, Ajanta Pharma Ltd, Apotex Inc, Dr Reddys Labs Ltd, Heritage Pharma Avet, Ipca Labs Ltd, Jubilant Cadista, Novitium Pharma, Prinston Inc, Ratiopharm, Renata, Rising, Sun Pharm Inds Inc, Synthon Pharms, Torrent Pharms, Watson Labs, West Ward Pharms, and Zydus Pharms Usa Inc, and is included in forty-eight NDAs. It is available from thirty-five 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. Forty suppliers are listed for this compound. Additional details are available on the risperidone profile page.

Summary for 091537

Tradename:	RISPERIDONE
Applicant:	Dash Pharms
Ingredient:	risperidone
Patents:	0

Pharmacology for NDA: 091537

Medical Subject Heading (MeSH) Categories for 091537

Antipsychotic Agents
Dopamine Antagonists
Serotonin Antagonists

Suppliers and Packaging for NDA: 091537

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
RISPERIDONE	risperidone	TABLET, ORALLY DISINTEGRATING;ORAL	091537	ANDA	Natco Pharma USA LLC	69339-181	69339-181-03	30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (69339-181-03)
RISPERIDONE	risperidone	TABLET, ORALLY DISINTEGRATING;ORAL	091537	ANDA	Natco Pharma USA LLC	69339-182	69339-182-03	30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (69339-182-03)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	0.5MG
Approval Date:	Mar 30, 2011	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	1MG
Approval Date:	Mar 30, 2011	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	2MG
Approval Date:	Mar 30, 2011	TE:		RLD:	No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification 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.