GENENTECH INC FDA Approval BLA 761197

BLA 761197

GENENTECH INC

FDA Drug Application

Application #761197

Documents

Letter2021-10-25
Label2021-10-25

Application Sponsors

BLA 761197GENENTECH INC

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION100MG/ML0SUSVIMORANOBIZUMAB

FDA Submissions

TYPE 2; Type 2 - New Active IngredientORIG1AP2021-10-22PRIORITY

Submissions Property Types

ORIG1Null40

CDER Filings

GENENTECH INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761197
            [companyName] => GENENTECH INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"SUSVIMO","activeIngredients":"RANOBIZUMAB","strength":"100MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"10\/22\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/761197s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"10\/22\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/761197s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/761197Orig1s000_ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-10-22
        )

)

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