GENENTECH FDA Approval BLA 761121

BLA 761121

GENENTECH

FDA Drug Application

Application #761121

Documents

Label2019-06-10
Review2019-07-02
Letter2019-07-03

Application Sponsors

BLA 761121GENENTECH

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION140MG0POLIVYPOLATUZUMAB VEDOTIN-PIIQ

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2019-06-10PRIORITY

Submissions Property Types

ORIG1Null6

CDER Filings

GENENTECH
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761121
            [companyName] => GENENTECH
            [docInserts] => ["",""]
            [products] => [{"drugName":"POLIVY","activeIngredients":"POLATUZUMAB VEDOTIN-PIIQ","strength":"140MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"06\/10\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761121s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"06\/10\/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\\\/761121s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/761121Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/761121Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2019-06-10
        )

)

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