SECUADO
These highlights do not include all the information needed to use SECUADO (asenapine) transdermal system safely and effectively. See full prescribing information for SECUADO. SECUADO (asenapine) transdermal system Initial U.S. Approval: 2009
Approved
Approval ID
685eaf44-5944-4f38-afba-0a4fc0b3462b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 28, 2023
Manufacturers
FDA
Noven Therapeutics, LLC
DUNS: 166888268
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 Code68968-0174
Application NumberNDA212268
Product Classification
M
Marketing Category
C73594
G
Generic Name
ASENAPINE
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateMay 22, 2023
FDA Product Classification
INGREDIENTS (6)
ASENAPINEActive
Quantity: 7.6 mg in 1 d
Code: JKZ19V908O
Classification: ACTIB
POLYISOBUTYLENE (1100000 MW)Inactive
Code: FLT10CH37X
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
ISOPROPYL PALMITATEInactive
Code: 8CRQ2TH63M
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
SODIUM ACETATE ANHYDROUSInactive
Code: NVG71ZZ7P0
Classification: IACT
ASENAPINE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68968-0173
Application NumberNDA212268
Product Classification
M
Marketing Category
C73594
G
Generic Name
ASENAPINE
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateMay 22, 2023
FDA Product Classification
INGREDIENTS (6)
ASENAPINEActive
Quantity: 5.7 mg in 1 d
Code: JKZ19V908O
Classification: ACTIB
POLYISOBUTYLENE (1100000 MW)Inactive
Code: FLT10CH37X
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
SODIUM ACETATE ANHYDROUSInactive
Code: NVG71ZZ7P0
Classification: IACT
ISOPROPYL PALMITATEInactive
Code: 8CRQ2TH63M
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
ASENAPINE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68968-0172
Application NumberNDA212268
Product Classification
M
Marketing Category
C73594
G
Generic Name
ASENAPINE
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateMay 22, 2023
FDA Product Classification
INGREDIENTS (6)
ASENAPINEActive
Quantity: 3.8 mg in 1 d
Code: JKZ19V908O
Classification: ACTIB
POLYISOBUTYLENE (1100000 MW)Inactive
Code: FLT10CH37X
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
SODIUM ACETATE ANHYDROUSInactive
Code: NVG71ZZ7P0
Classification: IACT
ISOPROPYL PALMITATEInactive
Code: 8CRQ2TH63M
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT