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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 201003


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NDA 201003 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-two 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-seven suppliers are listed for this compound. Additional details are available on the risperidone profile page.
Summary for 201003
Tradename:RISPERIDONE
Applicant:Ajanta Pharma Ltd
Ingredient:risperidone
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 201003
Medical Subject Heading (MeSH) Categories for 201003
Suppliers and Packaging for NDA: 201003
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RISPERIDONE risperidone TABLET;ORAL 201003 ANDA Ajanta Pharma USA Inc. 27241-001 27241-001-06 60 TABLET in 1 BOTTLE (27241-001-06)
RISPERIDONE risperidone TABLET;ORAL 201003 ANDA Ajanta Pharma USA Inc. 27241-001 27241-001-50 500 TABLET in 1 BOTTLE (27241-001-50)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.25MG
Approval Date:Aug 24, 2011TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG
Approval Date:Aug 24, 2011TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Aug 24, 2011TE:ABRLD:No

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