NDC 47335-0767-83
Paliperidone 9 mg/1 TABLET, FILM COATED, EXTENDED RELEASE
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NDC
47335-0767-83
Generic Name
Paliperidone
Brand Name
Paliperidone
Strength
9 mg/1
Dosage Form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Package Size
—
Labeler
Sun Pharmaceutical Industries, Inc.
FDA Drug Information
Indications & 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 )…
Source: FDA. For professional use only. Not a substitute for prescribing information.
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