paliperidone
paliperidone is listed in the FDA National Drug Code directory with 26 NDC codes, marketed under brand names including Paliperidone, PALIPERIDONE, INVEGA. Available dosage forms: powder, tablet, extended release, tablet, film coated, extended release.
Drug Details
- Generic Name
- paliperidone
- Brand Names
- Paliperidone, PALIPERIDONE, INVEGA, paliperidone
- Application Number
- ANDA212807
- Sponsor
- Jubilant Biosys limited
- NDC Codes
- 26
- Dosage Forms
- POWDER, TABLET, EXTENDED RELEASE, TABLET, FILM COATED, EXTENDED RELEASE
- Routes
- ORAL
- Active Ingredients
- PALIPERIDONE
Indications and Usage
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 to 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.