GENENTECH FDA Approval BLA 761149

BLA 761149

GENENTECH

FDA Drug Application

Application #761149

Documents

Label2020-08-17
Letter2020-08-17
Review2020-09-11

Application Sponsors

BLA 761149GENENTECH

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION120MG/ML0ENSPRYNGSATRALIZUMAB

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2020-08-14STANDARD

Submissions Property Types

ORIG1Null7

CDER Filings

GENENTECH
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761149
            [companyName] => GENENTECH
            [docInserts] => ["",""]
            [products] => [{"drugName":"ENSPRYNG","activeIngredients":"SATRALIZUMAB","strength":"120MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"08\/14\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761149s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"08\/14\/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\\\/761149s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/761149Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-08-14
        )

)

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