BLA 761121

GENENTECH

FDA Drug Application

Application #761121

Documents

• Label: 2019-06-10
• Review: 2019-07-02
• Letter: 2019-07-03
• Letter: 2021-01-12
• Label: 2021-01-12

Application Sponsors

BLA 761121

GENENTECH

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE;INJECTION	140MG	0	POLIVY	POLATUZUMAB VEDOTIN-PIIQ
002	POWDER;INTRAVENOUS	30MG/VIAL	0	POLIVY	POLATUZUMAB VEDOTIN-PIIQ

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2019-06-10	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2020-09-18	N/A

Submissions Property Types

ORIG

1

Null

6

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
        )

)