Risperidone

Product manufactured by Wockhardt Limited

Application Nr Approved Date Route Status External Links
ANDA078744 2009-10-08 Oral DISCN Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1indications And Usage Risperidone Is An Atypical Antipsychotic Agent Indicated For: Treatment Of Schizophrenia In Adults (1.1) Alone, Or In Combination With Lithium Or Valproate, For The Short-Term Treatment Of Acute Manic Or Mixed Episodes Associated With Bipolar I Disorder In Adults (1.2) Due To Janssen Pharmaceuticals Corporation’s Marketing Exclusivity Rights, This Drug Product Is Not Labeled For Use In Pediatric Patients With Schizophrenia, Bipolar Mania Or Autistic Disorder.(1.1,1.2,1.3) 1.1schizophrenia Adults Risperidone Oral Solution Is Indicated For The Acute And Maintenance Treatment Of Schizophrenia [see Clinical Studies (14.1)]. Adolescents Due To Janssen Pharmaceuticals Corporation’s Marketing Exclusivity Rights, This Drug Product Is Not Labeled For Use In Pediatric Patients With Schizophrenia. Pediatric Use Information For The Treatment Of Pediatric Patients With Schizophrenia, 13 To 17 Years Of Age, Is Approved For Janssen Pharmaceuticals Corporation’s Risperidone Drug Products. 1.2bipolar Mania Monotherapy - Adults And Pediatrics Risperidone Oral Solution Is Indicated For The Short-Term Treatment Of Acute Manic Or Mixed Episodes Associated With Bipolar I Disorder In Adults [see Clinical Studies (14.2)]. Due To Janssen Pharmaceuticals Corporation’s Marketing Exclusivity Rights, This Drug Product Is Not Labeled For Use In Pediatric Patients With Bipolar Mania. Pediatric Use Information For The Treatment Of Pediatric Patients With Bipolar Mania, 10 To 17 Years Of Age, Is Approved For Janssen Pharmaceuticals Corporation’s Risperidone Drug Products. Combination Therapy – Adults The Combination Of Risperidone Oral Solution With Lithium Or Valproate Is Indicated For The Short-Term Treatment Of Acute Manic Or Mixed Episodes Associated With Bipolar I Disorder [see Clinical Studies (14.3)]. 1.3irritability Associated With Autistic Disorder Pediatrics Due To Janssen Pharmaceuticals Corporation’s Marketing Exclusivity Rights, This Drug Product Is Not Labeled For Use In Pediatric Patients With Irritability Associated With Autistic Disorder. Information Regarding The Treatment Of Pediatric Patients With Irritability Associated With Autistic Disorder, 5 To 16 Years Of Age, Is Approved For Janssen Pharmaceuticals Corporation’s Risperidone Drug Products.

All Formulated Excipients (5 Total)

Name Structure Kind Function Status
1. Malic Acid MALIC ACID Molecular
2. Hydroxypropyl .beta.-Cyclodextrin HYDROXYPROPYL .BETA.-CYCLODEXTRIN Unresolved
3. Methylparaben Sodium METHYLPARABEN SODIUM Molecular
4. Saccharin Sodium SACCHARIN SODIUM Molecular
5. Edetate Disodium EDETATE DISODIUM Molecular

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Risperidone RISPERIDONE ZINC538312

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