SANOFI AVENTIS US FDA Approval BLA 761113

BLA 761113

SANOFI AVENTIS US

FDA Drug Application

Application #761113

Documents

Label2020-03-02
Letter2020-03-04
Review2020-03-25

Application Sponsors

BLA 761113SANOFI AVENTIS US

Marketing Status

Prescription001
Prescription002

Application Products

001INJECTABLE;INJECTION100MG/5ML (20MG/ML)0SARCLISAISATUXIMAB-IRFC
002INJECTABLE;INJECTION500MG/25ML (20MG/ML)0SARCLISAISATUXIMAB-IRFC

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2020-03-02STANDARD

Submissions Property Types

ORIG1Null15

CDER Filings

SANOFI AVENTIS US
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761113
            [companyName] => SANOFI AVENTIS US
            [docInserts] => ["",""]
            [products] => [{"drugName":"SARCLISA","activeIngredients":"ISATUXIMAB-IRFC","strength":"100MG\/5ML (20MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"SARCLISA","activeIngredients":"ISATUXIMAB-IRFC","strength":"500MG\/25ML (20MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"03\/02\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761113s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"03\/02\/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\\\/761113s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/761113Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2020\\\/761113Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-03-02
        )

)

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