SAPHRIS
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
Approved
Approval ID
5429f134-839f-4ffc-9944-55f51238def8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 1, 2021
Manufacturers
FDA
Allergan, Inc.
DUNS: 144796497
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Asenapine Maleate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0456-2402
Application NumberNDA022117
Product Classification
M
Marketing Category
C73594
G
Generic Name
Asenapine Maleate
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateJuly 31, 2023
FDA Product Classification
INGREDIENTS (4)
ASENAPINE MALEATEActive
Quantity: 2.5 mg in 1 1
Code: CU9463U2E2
Classification: ACTIM
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
mannitolInactive
Code: 3OWL53L36A
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
Asenapine Maleate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0456-2405
Application NumberNDA022117
Product Classification
M
Marketing Category
C73594
G
Generic Name
Asenapine Maleate
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateJuly 31, 2023
FDA Product Classification
INGREDIENTS (4)
ASENAPINE MALEATEActive
Quantity: 5 mg in 1 1
Code: CU9463U2E2
Classification: ACTIM
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
mannitolInactive
Code: 3OWL53L36A
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
Asenapine Maleate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0456-2410
Application NumberNDA022117
Product Classification
M
Marketing Category
C73594
G
Generic Name
Asenapine Maleate
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateJuly 31, 2023
FDA Product Classification
INGREDIENTS (4)
ASENAPINE MALEATEActive
Quantity: 10 mg in 1 1
Code: CU9463U2E2
Classification: ACTIM
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
mannitolInactive
Code: 3OWL53L36A
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT