ABLYNX NV FDA Approval BLA 761112

BLA 761112

ABLYNX NV

FDA Drug Application

Application #761112

Documents

Label2019-02-06
Letter2019-02-13
Review2019-03-15

Application Sponsors

BLA 761112ABLYNX NV

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION11MG/VIAL0CABLIVICAPLACIZUMAB-YHDP

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2019-02-06PRIORITY

Submissions Property Types

ORIG1Null2

CDER Filings

ABLYNX NV
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761112
            [companyName] => ABLYNX NV
            [docInserts] => ["",""]
            [products] => [{"drugName":"CABLIVI","activeIngredients":"CAPLACIZUMAB-YHDP","strength":"11MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"02\/06\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761112Orig1s000ltr.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"02\/06\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761112Orig1s000ltr.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/761112Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/761112Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2019-02-06
        )

)

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