Basic Information
SAPHRIS
0456-2405
Regulatory Information
0456-2405
NDA022117
C73594
July 31, 2023
USA
These highlights do not include all the information needed to use SAPHRIS (asenapine) sublingual tablets safely and effectively. See full prescribing information for SAPHRIS. SAPHRIS (asenapine) sublingual tablets Initial U.S. Approval: 2009
HUMAN PRESCRIPTION DRUG LABEL
17
Company Information
144796497
Active Ingredients
GELATIN, UNSPECIFIED
Code: 2G86QN327L
Class Code: IACT
mannitol
Code: 3OWL53L36A
Class Code: IACT
SUCRALOSE
Code: 96K6UQ3ZD4
Class Code: IACT
Active Moieties
Asenapine
Code: JKZ19V908O