Application Nr Approved Date Route Status External Links
ANDA079088 2008-10-30 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 Tablets Are 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 Tablets Are Indicated For The Short-Term 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 Tablets Adjunctive Therapy With Lithium Or Valproate Is Indicated For The Short-Term 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 3 Short-Term Trials In Children And Adolescents (ages 5 To 17 Years) [see Clinical Studies (14.4)].

All Formulated Excipients (7 Total)

Name Structure Kind Function Status
1. Anhydrous Lactose ANHYDROUS LACTOSE Molecular
2. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
3. Hypromelloses HYPROMELLOSES Unresolved
4. 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.
5. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
6. Polyethylene Glycol 400 POLYETHYLENE GLYCOL 400 Unresolved
7. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

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

Comments