TAIHO ONCOLOGY FDA Approval NDA 214801

NDA 214801

TAIHO ONCOLOGY

FDA Drug Application

Application #214801

Documents

Letter2022-10-03
Label2022-10-05
Review2022-11-08

Application Sponsors

NDA 214801TAIHO ONCOLOGY

Marketing Status

Prescription001

Application Products

001TABLET, FILM COATED4MG0LYTGOBIFUTIBATINIB

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2022-09-30PRIORITY

Submissions Property Types

ORIG1Null2

CDER Filings

TAIHO ONCOLOGY
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214801
            [companyName] => TAIHO ONCOLOGY
            [docInserts] => ["",""]
            [products] => [{"drugName":"LYTGOBI","activeIngredients":"FUTIBATINIB","strength":"4MG","dosageForm":"TABLET, FILM COATED","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/30\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/214801Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-09-30
        )

)

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