Application 214962

Type
NDA
Sponsor
HANDA NEUROSCIENCE LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TASCENSO ODTFINGOLIMOD LAURYL SULFATETABLET;ORALLY DISINTEGRATING0.25MGNoNo
002TASCENSO ODTFINGOLIMOD LAURYL SULFATETABLET;ORALLY DISINTEGRATING0.5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70709-062TASCENSO ODTFingolimod Lauryl SulfateCycle Pharmaceuticals LtdNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81152SUPPL 2025-02-07
80995SUPPL 2025-02-05
80994SUPPL 2025-02-05
78730SUPPL 2024-07-02
78694SUPPL 2024-06-06
75060SUPPL 2023-08-14
75048SUPPL 2023-08-11
75047ORIG 2022-12-12
72859ORIG2022-12-12
72858ORIG2022-12-12
70655ORIG2022-03-30
69790ORIG2021-12-28
69789ORIG2021-12-28
69036ORIG2021-10-20