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 Is An Atypical Antipsychotic Agent Indicated For: Treatment Of Schizophrenia In Adults And Adolescents Aged 13 To 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 To 17 Years. (1.2) Treatment Of Irritability Associated With Autistic Disorder In Children And Adolescents Aged 5 To 16 Years. (1.3) 1.1 Schizophrenia Adults Risperidone Tablets Are Indicated For The Acute And Maintenance Treatment Of Schizophrenia [see Clinical Studies (14.1)]. Adolescents Risperidone Tablets Are 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 Tablets Are 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 Tablets With Lithium Or Valproate Are 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 Tablets Are Indicated For The Treatment Of Irritability Associated With Autistic Disorder In Children And Adolescents Aged 5 To 16 Years, Including Symptoms Of Aggression Towards Others, Deliberate Self-Injuriousness, Temper Tantrums And Quickly Changing Moods [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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