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Generated: October 22, 2018

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Details for New Drug Application (NDA): 079158

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NDA 079158 describes RISPERIDONE, which is a drug marketed by Amneal Pharms, Ani Pharms Inc, Apotex Inc, Aurobindo Pharma Ltd, Bio Pharm Inc, Lannett Co Inc, Precision Dose, Taro, Tris Pharma Inc, West-ward Pharms Int, Wockhardt, Actavis Labs Fl Inc, Dr Reddys Labs Ltd, Jubilant Generics, Mylan Pharms Inc, Par Pharm, Sandoz, Sun Pharm Inds Ltd, Teva, Zydus Pharms Usa, Ajanta Pharma Ltd, Aurobindo Pharma, Chartwell Molecular, Jubilant Cadista, Mylan, Oxford Pharms, Pliva Hrvatska Doo, 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 fifty-four 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. Fifty-six suppliers are listed for this compound. Additional details are available on the risperidone profile page.
Summary for 079158
Tradename:RISPERIDONE
Applicant:Lannett Co Inc
Ingredient:risperidone
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 079158
Medical Subject Heading (MeSH) Categories for 079158
Suppliers and Packaging for NDA: 079158
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RISPERIDONE risperidone SOLUTION;ORAL 079158 ANDA Par Pharmaceutical 0603-9424 0603-9424-45 1 BOTTLE in 1 CARTON (0603-9424-45) > 30 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength1MG/ML
Approval Date:Dec 3, 2010TE:AARLD:No

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