Asenapine Maleate
Asenapine Maleate is listed in the FDA National Drug Code directory with 17 NDC codes, marketed under brand name including SAPHRIS. Available dosage forms: tablet, powder.
Drug Details
- Generic Name
- Asenapine Maleate
- Brand Names
- SAPHRIS
- Application Number
- NDA022117
- Sponsor
- Allergan, Inc.
- NDC Codes
- 17
- Dosage Forms
- TABLET, POWDER
- Routes
- SUBLINGUAL
- Active Ingredients
- ASENAPINE MALEATE
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