SAMSUNG BIOEPIS CO LTD FDA Approval BLA 761202

BLA 761202

SAMSUNG BIOEPIS CO LTD

FDA Drug Application

Application #761202

Documents

Label2021-09-20
Letter2021-09-21
Review2021-10-01

Application Sponsors

BLA 761202SAMSUNG BIOEPIS CO LTD

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION0.5MG(10MG/ML)0BYOOVIZRANIBIZUMAB-NUNA

FDA Submissions

TYPE 2; Type 2 - New Active IngredientORIG1AP2021-09-17STANDARD

Submissions Property Types

ORIG1Null40

CDER Filings

SAMSUNG BIOEPIS CO LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761202
            [companyName] => SAMSUNG BIOEPIS CO LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"BYOOVIZ","activeIngredients":"RANIBIZUMAB-NUNA","strength":"0.5MG(10MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"09\/17\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/761202s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"09\/17\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/761202s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/761202Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-09-17
        )

)

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