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Last Updated: November 12, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077494

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NDA 077494 describes RISPERIDONE, which is a drug marketed by Amneal Pharms, Ani Pharms Inc, Apotex Inc, Aurobindo Pharma Ltd, Lannett Co Inc, Precision Dose, Taro, Torrent, Tris Pharma Inc, West-ward Pharms Int, Wockhardt, Actavis Labs Fl Inc, Dr Reddys Labs Ltd, Heritage Pharma, Jubilant Generics, Mylan Pharms Inc, Par Pharm, Sandoz, Sun Pharm Inds Ltd, Zydus Pharms Usa, Ajanta Pharma Ltd, Celltrion, Ceyone, Chartwell Molecular, Jubilant Cadista, Mylan, Oxford Pharms, 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 forty-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. Forty-four suppliers are listed for this compound. Additional details are available on the risperidone profile page.
Summary for 077494
Applicant:Par Pharm
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) > 5 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

Approval Date:Apr 30, 2009TE:ABRLD:No

Profile for product number 003

Approval Date:Oct 26, 2009TE:ABRLD:No

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