NOVIMMUNE S.A. FDA Approval BLA 761107

BLA 761107

NOVIMMUNE S.A.

FDA Drug Application

Application #761107

Documents

Letter2018-11-20
Label2018-11-21
Review2018-12-17

Application Sponsors

BLA 761107NOVIMMUNE S.A.

Marketing Status

Prescription001
Prescription002

Application Products

001INJECTABLE;INJECTION10MG/2ML0GAMIFANTEMAPALUMAB-LZSG
002INJECTABLE;INJECTION50MG/10ML0GAMIFANTEMAPALUMAB-LZSG

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2018-11-20PRIORITY

Submissions Property Types

ORIG1Null15

CDER Filings

NOVIMMUNE S.A.
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            [ApplNo] => 761107
            [companyName] => NOVIMMUNE S.A.
            [docInserts] => ["",""]
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            [labels] => [{"actionDate":"11\/20\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/761107s000lbl.pdf\"}]","notes":""}]
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            [supplements] => 
            [actionDate] => 2018-11-20
        )

)

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