GENENTECH INC FDA Approval BLA 761263

BLA 761263

GENENTECH INC

FDA Drug Application

Application #761263

Documents

Label2022-12-23
Medication Guide2022-12-23
Letter2022-12-23

Application Sponsors

BLA 761263GENENTECH INC

Marketing Status

Prescription001
Prescription002

Application Products

001INJECTABLE;INJECTION1MG/ML0LUNSUMIOMOSUNETUZUMAB-AXGB
002INJECTABLE;INJECTION30MG/30ML0LUNSUMIOMOSUNETUZUMAB-AXGB

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2022-12-22PRIORITY

Submissions Property Types

ORIG1Null6

CDER Filings

GENENTECH INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761263
            [companyName] => GENENTECH INC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2022\/761263s000lbl.pdf#page=21"]
            [products] => [{"drugName":"LUNSUMIO","activeIngredients":"MOSUNETUZUMAB-AXGB","strength":"1MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"LUNSUMIO","activeIngredients":"MOSUNETUZUMAB-AXGB","strength":"30MG\/30ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"12\/22\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/761263s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"12\/22\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/761263s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/761263Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-12-22
        )

)

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