BLA 761197

GENENTECH INC

FDA Drug Application

Application #761197

Documents

• Letter: 2021-10-25
• Label: 2021-10-25
• Letter: 2022-04-19
• Label: 2022-04-20
• Review: 2022-09-21

Application Sponsors

BLA 761197

GENENTECH INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

100MG/ML

0

SUSVIMO

RANOBIZUMAB

FDA Submissions

TYPE 2; Type 2 - New Active Ingredient	ORIG	1	AP	2021-10-22	PRIORITY
LABELING; Labeling	SUPPL	2	AP	2022-04-18	STANDARD

Submissions Property Types

ORIG	1	Null	40
SUPPL	2	Null	7

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
        )

)