GENENTECH INC FDA Approval BLA 761170

BLA 761170

GENENTECH INC

FDA Drug Application

Application #761170

Documents

Letter2020-06-30
Label2020-07-08

Application Sponsors

BLA 761170GENENTECH INC

Marketing Status

Prescription001

Application Products

001INJECTABLE;INTRAVENOUS, SUBCUTANEOUS1200MG;600MG;30000UNITS0PHESGOPERTUZUMAB;TRASTUZUMAB;HYALURONIDASE-ZZXF

FDA Submissions

TYPE 4; Type 4 - New CombinationORIG1AP2020-06-29STANDARD

Submissions Property Types

ORIG1Null6

CDER Filings

GENENTECH INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761170
            [companyName] => GENENTECH INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PHESGO","activeIngredients":"PERTUZUMAB;TRASTUZUMAB;HYALURONIDASE-ZZXF","strength":"1200MG;600MG;30000UNITS","dosageForm":"INJECTABLE;INTRAVENOUS, SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/29\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/761170Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-06-29
        )

)

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