ORIGIN BIOSCIENCES INC FDA Approval NDA 214018

NDA 214018

ORIGIN BIOSCIENCES INC

FDA Drug Application

Application #214018

Documents

Letter2021-03-01
Label2021-02-26
Review2021-03-26
Letter2022-10-28
Label2022-11-01

Application Sponsors

NDA 214018ORIGIN BIOSCIENCES INC

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION9.5MG2NULIBRYFOSDENOPTERIN

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2021-02-26PRIORITY
EFFICACY; EfficacySUPPL2AP2022-10-27STANDARD

Submissions Property Types

ORIG1Null7
SUPPL2Null6

CDER Filings

ORIGIN BIOSCIENCES INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214018
            [companyName] => ORIGIN BIOSCIENCES INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"NULIBRY","activeIngredients":"FOSDENOPTERIN","strength":"9.5MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/26\/2021","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\\\/2021\\\/214018Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-02-26
        )

)

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