BLA 761149

GENENTECH

FDA Drug Application

Application #761149

Documents

• Label: 2020-08-17
• Letter: 2020-08-17
• Review: 2020-09-11
• Letter: 2021-05-04
• Label: 2021-05-07
• Label: 2022-09-15
• Medication Guide: 2022-09-15
• Letter: 2022-09-15

Application Sponsors

BLA 761149

GENENTECH

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

120MG/ML

0

ENSPRYNG

SATRALIZUMAB

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2020-08-14	STANDARD
LABELING; Labeling	SUPPL	2	AP	2021-05-03	STANDARD
LABELING; Labeling	SUPPL	5	AP	2022-09-14	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	6
SUPPL	5	Null	15

CDER Filings

GENENTECH

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761149
            [companyName] => GENENTECH
            [docInserts] => ["",""]
            [products] => [{"drugName":"ENSPRYNG","activeIngredients":"SATRALIZUMAB","strength":"120MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"08\/14\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761149s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"08\/14\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761149s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/761149Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-08-14
        )

)