Asenapine
These highlights do not include all the information needed to use asenapine sublingual tablets safely and effectively. See full prescribing information for asenapine . asenapine sublingual tablets Initial U.S. Approval: 2009
Approved
Approval ID
86a40942-8d6b-478c-995f-3c346b197463
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 24, 2017
Manufacturers
FDA
Greenstone LLC
DUNS: 825560733
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 Code59762-1091
Application NumberNDA022117
Product Classification
M
Marketing Category
C73605
G
Generic Name
asenapine maleate
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateOctober 18, 2023
FDA Product Classification
INGREDIENTS (4)
GELATINInactive
Code: 2G86QN327L
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
ASENAPINE MALEATEActive
Quantity: 2.5 mg in 1 1
Code: CU9463U2E2
Classification: ACTIM
asenapine maleate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59762-2888
Application NumberNDA022117
Product Classification
M
Marketing Category
C73605
G
Generic Name
asenapine maleate
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateOctober 18, 2023
FDA Product Classification
INGREDIENTS (4)
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
ASENAPINE MALEATEActive
Quantity: 10 mg in 1 1
Code: CU9463U2E2
Classification: ACTIM
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
asenapine maleate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59762-2012
Application NumberNDA022117
Product Classification
M
Marketing Category
C73605
G
Generic Name
asenapine maleate
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateOctober 18, 2023
FDA Product Classification
INGREDIENTS (4)
ASENAPINE MALEATEActive
Quantity: 5 mg in 1 1
Code: CU9463U2E2
Classification: ACTIM
GELATINInactive
Code: 2G86QN327L
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT