RIDGEBACK BIOTHERAPEUTICS FDA Approval BLA 761172

BLA 761172

RIDGEBACK BIOTHERAPEUTICS

FDA Drug Application

Application #761172

Documents

Letter2020-12-22
Label2020-12-21
Review2021-01-12

Application Sponsors

BLA 761172RIDGEBACK BIOTHERAPEUTICS

Marketing Status

Prescription001

Application Products

001POWDER;IV (INFUSION)400MG/VIAL0EBANGAANSUVIMAB-ZYKL

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2020-12-21PRIORITY

Submissions Property Types

ORIG1Null40

CDER Filings

RIDGEBACK BIOTHERAPEUTICS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761172
            [companyName] => RIDGEBACK BIOTHERAPEUTICS
            [docInserts] => ["",""]
            [products] => [{"drugName":"EBANGA","activeIngredients":"ANSUVIMAB-ZYKL","strength":"400MG\/VIAL","dosageForm":"POWDER;IV (INFUSION)","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/21\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A; Orphan","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/761172Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-12-21
        )

)

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