LEO PHARMA AS FDA Approval BLA 761180

BLA 761180

LEO PHARMA AS

FDA Drug Application

Application #761180

Documents

Label2021-12-28
Letter2021-12-28

Application Sponsors

BLA 761180LEO PHARMA AS

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION150MG/ML0ADBRYTRALOKINUMAB

FDA Submissions

TYPE 1/4; Type 1 - New Molecular Entity and Type 4 - New CombinationORIG1AP2021-12-27STANDARD

Submissions Property Types

ORIG1Null6

CDER Filings

LEO PHARMA AS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761180
            [companyName] => LEO PHARMA AS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ADBRY","activeIngredients":"TRALOKINUMAB","strength":"150MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"12\/27\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/761180s001lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"12\/27\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/761180s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/761180Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-12-27
        )

)

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