Application Nr Approved Date Route Status External Links
ANDA079059 2012-12-12 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 Indicated For: Treatment Of Schizophrenia (1.1) As Monotherapy Or Adjunctive Therapy With Lithium Or Valproate, For The Treatment Of Acute Manic Or Mixed Episodes Associated With Bipolar I Disorder (1.2) Treatment Of Irritability Associated With Autistic Disorder (1.3) 1.1 Schizophrenia Risperidone Oral Solution Is Indicated For The Treatment Of Schizophrenia. Efficacy Was Established In 4 Short-Term Trials In Adults, 2 Short-Term Trials In Adolescents (ages 13 To 17 Years), And One Long-Term Maintenance Trial In Adults [see Clinical Studies (14.1) ]. 1.2 Bipolar Mania Monotherapy Risperidone Oral Solution Is Indicated For The Treatment Of Acute Manic Or Mixed Episodes Associated With Bipolar I Disorder. Efficacy Was Established In 2 Short-Term Trials In Adults And One Short-Term Trial In Children And Adolescents (ages 10 To 17 Years) [see Clinical Studies (14.2) ]. Adjunctive Therapy Risperidone Oral Solution Adjunctive Therapy With Lithium Or Valproate Is Indicated For The Treatment Of Acute Manic Or Mixed Episodes Associated With Bipolar I Disorder. Efficacy Was Established In One Short-Term Trial In Adults [see Clinical Studies (14.3) ]. 1.3 Irritability Associated With Autistic Disorder Risperidone Oral Solution Is Indicated For The Treatment Of Irritability Associated With Autistic Disorder, Including Symptoms Of Aggression Towards Others, Deliberate Self-Injuriousness, Temper Tantrums, And Quickly Changing Moods. Efficacy Was Established In 3 Short-Term Trials In Children And Adolescents (ages 5 To 17 Years) [see Clinical Studies (14.4) ].

All Formulated Excipients (4 Total)

Name Structure Kind Function Status
1. Benzoic Acid BENZOIC ACID Molecular PRES-Chemical preservative GRAS-Generally recognized as safe.
2. 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.
3. Sorbitol SORBITOL Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.
4. Tartaric Acid TARTARIC ACID 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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