HORIZON THERAPEUTICS IRELAND FDA Approval BLA 761143

BLA 761143

HORIZON THERAPEUTICS IRELAND

FDA Drug Application

Application #761143

Documents

Letter2020-01-22
Label2020-01-22
Review2020-03-02

Application Sponsors

BLA 761143HORIZON THERAPEUTICS IRELAND

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION500MG2TEPEZZATEPROTUMUMAB-TRBW

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2020-01-21PRIORITY

Submissions Property Types

ORIG1Null2

CDER Filings

HORIZON THERAPEUTICS IRELAND
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761143
            [companyName] => HORIZON THERAPEUTICS IRELAND
            [docInserts] => ["",""]
            [products] => [{"drugName":"TEPEZZA","activeIngredients":"TEPROTUMUMAB-TRBW","strength":"500MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"01\/21\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761143s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"01\/21\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761143s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/761143Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2020\\\/761143Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-01-21
        )

)

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