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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 078474


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NDA 078474 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 078474
Tradename:RISPERIDONE
Applicant:Sun Pharm Inds Ltd
Ingredient:risperidone
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 078474
Medical Subject Heading (MeSH) Categories for 078474
Suppliers and Packaging for NDA: 078474
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RISPERIDONE risperidone TABLET, ORALLY DISINTEGRATING;ORAL 078474 ANDA Sun Pharmaceutical Industries, Inc. 63304-643 63304-643-05 500 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (63304-643-05)
RISPERIDONE risperidone TABLET, ORALLY DISINTEGRATING;ORAL 078474 ANDA Sun Pharmaceutical Industries, Inc. 63304-643 63304-643-17 10 POUCH in 1 BOX, UNIT-DOSE (63304-643-17) / 1 TABLET, ORALLY DISINTEGRATING in 1 POUCH (63304-643-11)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength3MG
Approval Date:Aug 6, 2010TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength4MG
Approval Date:Aug 6, 2010TE:ABRLD:No

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