Application Nr Approved Date Route Status External Links
ANDA203802 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Paliperidone Extended-Release Tablets Are An Atypical Antipsychotic Agent Indicated For Treatment Of Schizophrenia ( 1.1 ) Adults: Efficacy Was Established In Three 6-Week Trials And One Maintenance Trial. ( 14.1 ) Adolescents (ages 12-17): Efficacy Was Established In One 6-Week Trial. ( 14.1 ) Treatment Of Schizoaffective Disorder As Monotherapy And As An Adjunct To Mood Stabilizers And/or Antidepressants. ( 1.2 ) Efficacy Was Established In Two 6-Week Trials In Adult Patients. ( 14.2 ) 1.1 Schizophrenia Paliperidone Extended-Release Tablets Are Indicated For The Treatment Of Schizophrenia [see Clinical Studies (14.1) ] . The Efficacy Of Paliperidone Extended-Release Tablets In Schizophrenia Was Established In Three 6-Week Trials In Adults And One 6-Week Trial In Adolescents, As Well As One Maintenance Trial In Adults. 1.2 Schizoaffective Disorder Paliperidone Extended-Release Tablets Are Indicated For The Treatment Of Schizoaffective Disorder As Monotherapy And An Adjunct To Mood Stabilizers And/or Antidepressant Therapy [see Clinical Studies (14.2) ] . The Efficacy Of Paliperidone Extended-Release Tablets In Schizoaffective Disorder Was Established In Two 6-Week Trials In Adults.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Paliperidone PALIPERIDONE ZINC4214700

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