Asenapine
These highlights do not include all the information needed to use ASENAPINE SUBLINGUAL TABLETS safely and effectively. See full prescribing information for ASENAPINE SUBLINGUAL TABLETS. ASENAPINE sublingual tablets Initial U.S. Approval: 2009
Approved
Approval ID
cf587c48-9cd2-4dc5-b0e9-21783c5633a6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 20, 2023
Manufacturers
FDA
Alembic Pharmaceuticals Limited
DUNS: 650574663
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Asenapine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code46708-544
Application NumberANDA206098
Product Classification
M
Marketing Category
C73584
G
Generic Name
Asenapine
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateJanuary 20, 2023
FDA Product Classification
INGREDIENTS (7)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
ASENAPINEActive
Quantity: 2.5 mg in 1 1
Code: JKZ19V908O
Classification: ACTIB
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 2165RE0K14
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
Asenapine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code46708-198
Application NumberANDA206098
Product Classification
M
Marketing Category
C73584
G
Generic Name
Asenapine
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateJanuary 20, 2023
FDA Product Classification
INGREDIENTS (7)
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
ASENAPINEActive
Quantity: 5 mg in 1 1
Code: JKZ19V908O
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 2165RE0K14
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
Asenapine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code46708-199
Application NumberANDA206098
Product Classification
M
Marketing Category
C73584
G
Generic Name
Asenapine
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateJanuary 20, 2023
FDA Product Classification
INGREDIENTS (7)
ASENAPINEActive
Quantity: 10 mg in 1 1
Code: JKZ19V908O
Classification: ACTIB
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 2165RE0K14
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT