asenapine asenapine maleate tablet
1 INDICATIONS AND USAGE Asenapine sublingual tablets are indicated for: Schizophrenia in adults [see Clinical Studies (14.1) ] Bipolar I disorder [see Clinical Studies (14.2) ] Acute monotherapy of manic or mixed episodes, in adults and pediatric patients 10 to 17 years of age Adjunctive treatment to lithium or valproate in adults Maintenance monotherapy treatment in adults Asenapine sublingual tablets are an atypical antipsychotic indicated for ( 1 ): Schizophrenia in adults Bipolar I disorder Acute monotherapy treatment of manic or mixed episodes, in adults and pediatric patients 10 to 17 years of age Adjunctive treatment to lithium or valproate in adults Maintenance monotherapy treatment in adults
breckenridge pharmaceutical, inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING Asenapine sublingual tablets are supplied as: 5 mg Tablets round, white, uncoated tablets debossed "B" on one side and "1" on the other side. Child-resistant packaging Box of 60 - 6 blisters with 10 tablets NDC 51991-359-60 Hospital Unit Dose Box of 100 - 10 blisters with 10 tablets NDC 51991-359-11 10 mg Tablets round, white, uncoated tablets debossed "B" on one side and "2" on the other side. Child-resistant packaging Box of 60 - 6 blisters with 10 tablets NDC 51991-361-60 Hospital Unit Dose Box of 100 - 10 blisters with 10 tablets NDC 51991-361-11 2.5 mg Tablets, black cherry flavor white colored, round shaped, uncoated tablets debossed with "B" on one side and "5" on the other side. Child-resistant packaging Box of 60 - 6 blisters with 10 tablets NDC 51991-928-60 Hospital Unit Dose Box of 100 - 10 blisters with 10 tablets NDC 51991-928-11 5 mg Tablets, black cherry flavor round, white, uncoated tablets debossed "B" on one side and "3" on the other side. Child-resistant packaging Box of 60 - 6 blisters with 10 tablets NDC 51991-358-60 Hospital Unit Dose Box of 100 - 10 blisters with 10 tablets NDC 51991-358-11 10 mg Tablets, black cherry flavor round, white, uncoated tablets debossed "B" on one side and "4" on the other side. Child-resistant packaging Box of 60 - 6 blisters with 10 tablets NDC 51991-360-60 Hospital Unit Dose Box of 100 - 10 blisters with 10 tablets NDC 51991-360-11 Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].
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