BLA 761169

REGENERON PHARMACEUTICALS

FDA Drug Application

Application #761169

Documents

• Letter: 2020-10-15
• Label: 2020-10-15
• Review: 2020-11-12
• Letter: 2022-05-16
• Label: 2022-05-16

Application Sponsors

BLA 761169

REGENERON PHARMACEUTICALS

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION; INJECTION

16.7MG/1ML

0

INMAZEB

ATOLTIVIMAB; ODESIVIMAB; MAFTIVIMAB

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2020-10-14	PRIORITY
LABELING; Labeling	SUPPL	3	AP	2022-05-13	STANDARD

Submissions Property Types

ORIG	1	Null	40
SUPPL	3	Null	7

CDER Filings

REGENERON PHARMACEUTICALS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761169
            [companyName] => REGENERON PHARMACEUTICALS
            [docInserts] => ["",""]
            [products] => [{"drugName":"INMAZEB","activeIngredients":"ATOLTIVIMAB; ODESIVIMAB; MAFTIVIMAB","strength":"16.7MG\/1ML","dosageForm":"SOLUTION; INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"10\/14\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761169s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"10\/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\\\/761169s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/761169Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-10-14
        )

)