Asenapine
Drug Details
- Generic Name
- Asenapine
- Brand Names
- Asenapine
- Application Number
- ANDA206098
- Sponsor
- Alembic Pharmaceuticals Inc.
- NDC Codes
- 6
- Dosage Forms
- TABLET
- Routes
- SUBLINGUAL
- Active Ingredients
- ASENAPINE
Indications and Usage
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