Application Nr Approved Date Route Status External Links
ANDA202645 2015-08-03 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Paliperidone Is 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 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 In Schizoaffective Disorder Was Established In Two 6-Week Trials In Adults.

All Formulated Excipients (8 Total)

Name Structure Kind Function Status
1. Cellulose Acetate CELLULOSE ACETATE Unresolved
2. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
3. Hypromelloses HYPROMELLOSES Unresolved
4. Ferrosoferric Oxide FERROSOFERRIC OXIDE Unresolved
5. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
6. Povidones POVIDONES Unresolved
7. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
8. Sodium Chloride SODIUM CHLORIDE Unresolved GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

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

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