Application Nr Approved Date Route Status External Links
ANDA078909 2009-07-29 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Risperidone Is An Atypical Antipsychotic Agent Indicated For: Treatment Of Schizophrenia In Adults And Adolescents Aged 13-17 Years(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 And Alone In Children And Adolescents Aged 10-17 Years (1.2) Treatment Of Irritability Associated With Autistic Disorder In Children And Adolescents Aged 5-16 Years (1.3) 1.1 Schizophrenia Adults Risperidone Oral Solution Is Indicated For The Acute And Maintenance Treatment Of Schizophrenia [see Clinical Studies (14.1) ]. Adolescents Risperidone Oral Solution Is Indicated For The Treatment Of Schizophrenia In Adolescents Aged 13 To 17 Years [see Clinical Studies (14.1) ]. 1.2 Bipolar 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 And In Children And Adolescents Aged 10 To 17 Years[see Clinical Studies (14.2) ]. Combination Therapy – Adults The Combination Of Risperidone 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) ]. 1.3 Irritability Associated With Autistic Disorder Pediatrics Risperidone Oral Solution Is Indicated For The Treatment Of Irritability Associated With Autistic Disorder In Children And Adolescents Aged 5 To16 Years, Including Symptoms Of Aggression Towards Others, Deliberate Self-Injuriousness, Temper Tantrums, And Quickly Changing Moods [see Clinical Studies (14.4) ].

All Formulated Excipients (2 Total)

Name Structure Kind Function Status
1. Sodium Hydroxide SODIUM HYDROXIDE Unresolved BC-Boiler compound , B&N-Buffer & neutralizing agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
2. Sorbitol SORBITOL Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

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

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