NDA 214962

HANDA NEUROSCIENCE LLC

FDA Drug Application

Application #214962

Documents

• Letter: 2021-10-20
• Letter: 2021-12-28
• Label: 2021-12-28
• Review: 2022-03-30
• Label: 2022-12-12
• Medication Guide: 2022-12-12

Application Sponsors

NDA 214962

HANDA NEUROSCIENCE LLC

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002

Application Products

001	TABLET;ORALLY DISINTEGRATING	0.25MG	0	TASCENSO ODT	FINGOLIMOD LAURYL SULFATE
002	TABLET;ORALLY DISINTEGRATING	0.5MG	0	TASCENSO ODT	FINGOLIMOD LAURYL SULFATE

FDA Submissions

UNKNOWN;	ORIG	1	TA	2021-10-18	UNKNOWN
UNKNOWN;	ORIG	2	AP	2021-12-23	STANDARD

Submissions Property Types

ORIG	1	Null	31
ORIG	2	Null	31

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
        )

)