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Last Updated: September 19, 2020

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Details for New Drug Application (NDA): 076904

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NDA 076904 describes RISPERIDONE, which is a drug marketed by Amneal Pharms, Ani Pharms Inc, Aurobindo Pharma Ltd, Hikma, Lannett Co Inc, Pharm Assoc, Precision Dose, Taro, Torrent, Tris Pharma Inc, 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, Apotex Inc, Celltrion, Chartwell Molecular, Jubilant Cadista, Mylan, Oxford Pharms, Prinston Inc, Ratiopharm, Renata, Rising, 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 thirty-three 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 076904
Tradename:RISPERIDONE
Applicant:Hikma
Ingredient:risperidone
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 076904
Medical Subject Heading (MeSH) Categories for 076904
Suppliers and Packaging for NDA: 076904
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RISPERIDONE risperidone SOLUTION;ORAL 076904 ANDA West-Ward Pharmaceuticals Corp 0054-0063 0054-0063-44 30 mL in 1 BOTTLE (0054-0063-44)
RISPERIDONE risperidone SOLUTION;ORAL 076904 ANDA ATLANTIC BIOLOGICALS CORP. 17856-0063 17856-0063-1 120 SYRINGE in 1 BOX, UNIT-DOSE (17856-0063-1) > 1 mL in 1 SYRINGE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength1MG/ML
Approval Date:Jul 29, 2009TE:AARLD:No

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