ADC Therapeutics SA FDA Approval BLA 761196

BLA 761196

ADC Therapeutics SA

FDA Drug Application

Application #761196

Documents

Label2021-04-23
Letter2021-04-27

Application Sponsors

BLA 761196ADC Therapeutics SA

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION10MG0ZYNLONTALONCASTUXIMAB TESIRINE-LPYL

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2021-04-23PRIORITY

Submissions Property Types

ORIG1Null23

CDER Filings

ADC Therapeutics SA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761196
            [companyName] => ADC Therapeutics SA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZYNLONTA","activeIngredients":"LONCASTUXIMAB TESIRINE-LPYL","strength":"10MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"04\/23\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/761196s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"04\/23\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/761196s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/761196Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-04-23
        )

)

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