You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 29, 2024

Details for New Drug Application (NDA): 077494


✉ Email this page to a colleague

« Back to Dashboard


NDA 077494 describes RISPERIDONE, which is a drug marketed by Teva Pharms Usa Inc, Amneal Pharms, Ani Pharms, Apozeal Pharms, Aurobindo Pharma Ltd, Chartwell Molecular, Hikma, Lannett Co Inc, Pharm Assoc, Precision Dose, Taro, Tris Pharma Inc, Wockhardt, Actavis Labs Fl Inc, Chartwell Rx, Dash Pharms, Dr Reddys Labs Ltd, Jubilant Generics, Par Pharm, Sandoz, Sun Pharm Inds Ltd, Zydus Pharms Usa, Ajanta Pharma Ltd, Amneal, Apotex Inc, Celltrion, Heritage Pharma Avet, Jubilant Cadista, Prinston Inc, Ratiopharm, Rising, Sun Pharm Inds Inc, Synthon Pharms, Torrent Pharms, Watson Labs, West Ward Pharms, Westminster Pharms, and Zydus Pharms Usa Inc, and is included in forty-five NDAs. It is available from thirty-one 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. Thirty-six suppliers are listed for this compound. Additional details are available on the risperidone profile page.
Summary for 077494
Tradename:RISPERIDONE
Applicant:Par Pharm
Ingredient:risperidone
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 077494
Medical Subject Heading (MeSH) Categories for 077494
Suppliers and Packaging for NDA: 077494
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RISPERIDONE risperidone TABLET, ORALLY DISINTEGRATING;ORAL 077494 ANDA Par Pharmaceutical, Inc. 49884-212 49884-212-55 5 BLISTER PACK in 1 CARTON (49884-212-55) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (49884-212-52)
RISPERIDONE risperidone TABLET, ORALLY DISINTEGRATING;ORAL 077494 ANDA Par Pharmaceutical, Inc. 49884-311 49884-311-55 5 BLISTER PACK in 1 CARTON (49884-311-55) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength0.25MG
Approval Date:Apr 30, 2009TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength0.5MG
Approval Date:Apr 30, 2009TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength1MG
Approval Date:Oct 26, 2009TE:ABRLD: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. 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.