Asenapine
Asenapine is listed in the FDA National Drug Code directory with 6 NDC codes, marketed under brand name including Asenapine. Available dosage form: tablet.
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 AN D USAGE SAPHRIS is 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 SAPHRIS is 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