Application Nr Approved Date Route Status External Links
ANDA076288 2008-09-15 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Risperidone Tablets Are 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 Tablets Are Indicated For The Treatment Of Schizophrenia. Efficacy Was Established In Four Short-Term Trials In Adults, Two 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 Tablets Are Indicated For The Treatment Of Acute Manic Or Mixed Episodes Associated With Bipolar I Disorder. Efficacy Was Established In Two 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 Tablets Adjunctive Therapy With Lithium Or Valproate Are 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 Tablets Are 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 Three Short-Term Trials In Children And Adolescents (ages 5 To 17 Years) [see Clinical Studies (14.4)].

All Formulated Excipients (10 Total)

Name Structure Kind Function Status
1. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
2. Docusate Sodium DOCUSATE SODIUM Molecular
3. Hypromelloses HYPROMELLOSES Unresolved
4. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
5. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
6. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
7. Polydextrose POLYDEXTROSE Unresolved MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
8. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
9. Sodium Benzoate SODIUM BENZOATE Molecular
10. Sodium Lauryl Sulfate SODIUM LAURYL SULFATE Molecular AF-Antifoaming (or defoaming) agent , CTG-Component or coating , EMUL-Emulsifier , SANI-Sanitizing agent , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.

Active Ingredients ( 1 Total)

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

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