HANDA NEUROSCIENCE LLC FDA Approval NDA 214962

NDA 214962

HANDA NEUROSCIENCE LLC

FDA Drug Application

Application #214962

Documents

Letter2021-10-20

Application Sponsors

NDA 214962HANDA NEUROSCIENCE LLC

Marketing Status

None (Tentative Approval)001
None (Tentative Approval)002

Application Products

001TABLET;ORALLY DISINTEGRATING0.25MG0TASCENSO ODTFINGOLIMOD LAURYL SULFATE
002TABLET;ORALLY DISINTEGRATING0.5MG0TASCENSO ODTFINGOLIMOD LAURYL SULFATE

FDA Submissions

UNKNOWN; ORIG1TA2021-10-18UNKNOWN

Submissions Property Types

ORIG1Null31

CDER Filings

HANDA NEUROSCIENCE LLC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214962
            [companyName] => HANDA NEUROSCIENCE LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"TASCENSO ODT","activeIngredients":"FINGOLIMOD LAURYL SULFATE","strength":"0.25MG","dosageForm":"TABLET;ORALLY DISINTEGRATING","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"TASCENSO ODT","activeIngredients":"FINGOLIMOD LAURYL SULFATE","strength":"0.5MG","dosageForm":"TABLET;ORALLY DISINTEGRATING","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/18\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"UNKNOWN","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-10-18
        )

)

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