TASCENSO ODT
These highlights do not include all the information needed to use TASCENSO ODT™ safely and effectively. See full prescribing information for TASCENSO ODT. TASCENSO ODT (fingolimod) orally disintegrating tablets Initial U.S. Approval: 2010
Approved
Approval ID
bf8e7f89-ea09-43c7-a7eb-e44724350721
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 17, 2023
Manufacturers
FDA
Cycle Pharmaceuticals Ltd
DUNS: 218215530
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fingolimod Lauryl Sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70709-065
Application NumberNDA214962
Product Classification
M
Marketing Category
C73594
G
Generic Name
Fingolimod Lauryl Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 24, 2023
FDA Product Classification
INGREDIENTS (6)
Fingolimod Lauryl SulfateActive
Quantity: 0.5 mg in 1 1
Code: J3HZQ9BE2S
Classification: ACTIM
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
Sodium ChlorideInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
Fingolimod Lauryl Sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70709-062
Application NumberNDA214962
Product Classification
M
Marketing Category
C73594
G
Generic Name
Fingolimod Lauryl Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 24, 2023
FDA Product Classification
INGREDIENTS (6)
Fingolimod Lauryl SulfateActive
Quantity: 0.25 mg in 1 1
Code: J3HZQ9BE2S
Classification: ACTIM
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
Sodium ChlorideInactive
Code: 451W47IQ8X
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT