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paliperidone 6 mg

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.

sun pharmaceutical industries, inc.


2 years ago ROUND YELLOW 766 paliperidone 6 mg

ROUND YELLOW 766

16 HOW SUPPLIED/STORAGE AND HANDLING

PALIPERIDONE extended-release tablets are available in the following strengths and packages. 1.5 mg tablets are brown, circular, biconvex, beveled edged, film-coated tablets imprinted with “744” in black ink on one side and plain on the other side. NDC Number Size 47335-744-83 Bottle of 30 Tablets with Child Resistant Cap 47335-744-88 Bottle of 100 Tablets with Child Resistant Cap 3 mg tablets are white to off-white, circular, biconvex, beveled edged, film-coated tablets imprinted with “765” in black ink on one side and plain on the other side. NDC Number Size 47335-765-83 Bottle of 30 Tablets with Child Resistant Cap 47335-765-88 Bottle of 100 Tablets with Child Resistant Cap 6 mg tablets are yellow, circular, biconvex, beveled edged, film-coated tablets imprinted with “766” in black ink on one side and plain on the other side. NDC Number Size 47335-766-83 Bottle of 30 Tablets with Child Resistant Cap 47335-766-88 Bottle of 100 Tablets with Child Resistant Cap 9 mg tablets are pink, circular, biconvex, beveled edged, film-coated tablets imprinted with “767” in black ink on one side and plain on the other side. NDC Number Size 47335-767-83 Bottle of 30 Tablets with Child Resistant Cap 47335-767-88 Bottle of 100 Tablets with Child Resistant Cap Storage and Handling Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Protect from moisture. Keep out of reach of children.


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