BLA 761041

GENENTECH INC

FDA Drug Application

Application #761041

Documents

• Label: 2016-10-18
• Letter: 2016-10-20
• Medication Guide: 2016-11-28
• Review: 2016-12-27
• Summary Review: 2016-12-27

Application Sponsors

BLA 761041

GENENTECH INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE; INJECTION

1200MG/20ML

0

TECENTRIQ

ATEZOLIZUMAB

FDA Submissions

TYPE 9- BLA; Type 9 - New indication submitted as distinct BLA, consolidated

ORIG

1

AP

2016-10-18

PRIORITY

Submissions Property Types

ORIG

1

Null

15

CDER Filings

GENENTECH INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761041
            [companyName] => GENENTECH INC
            [docInserts] => ["Medication Guide","http:\/\/www.fda.gov\/downloads\/Drugs\/DrugSafety\/ucm530718.pdf"]
            [products] => [{"drugName":"TECENTRIQ","activeIngredients":"ATEZOLIZUMAB","strength":"1200MG\/20ML","dosageForm":"INJECTABLE; INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"10\/18\/2016","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/761041s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"10\/18\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/761041s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/761041Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/761041Orig1_toc.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/761041Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2016-10-18
        )

)