JANSSEN BIOTECH FDA Approval BLA 761210

BLA 761210

JANSSEN BIOTECH

FDA Drug Application

Application #761210

Documents

Label2021-05-21
Letter2021-05-24

Application Sponsors

BLA 761210JANSSEN BIOTECH

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION350MG/7ML(50MG/ML)0RYBREVANTAMIVANTAMAB-VMJW

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2021-05-21PRIORITY

Submissions Property Types

ORIG1Null7

CDER Filings

JANSSEN BIOTECH
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761210
            [companyName] => JANSSEN BIOTECH
            [docInserts] => ["",""]
            [products] => [{"drugName":"RYBREVANT","activeIngredients":"AMIVANTAMAB-VMJW","strength":"350MG\/7ML(50MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"05\/21\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/761210s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"05\/21\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/761210s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/761210Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-05-21
        )

)

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