SEAGEN FDA Approval BLA 761208

BLA 761208

SEAGEN

FDA Drug Application

Application #761208

Documents

Label2021-09-20
Medication Guide2021-09-20
Letter2021-09-21
Review2021-10-07

Application Sponsors

BLA 761208SEAGEN

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION40MG0TIVDAKTISOTUMAB VEDOTIN-TFTV

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2021-09-20PRIORITY

Submissions Property Types

ORIG1Null40

CDER Filings

SEAGEN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761208
            [companyName] => SEAGEN
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2021\/761208s000lbl.pdf#page=21"]
            [products] => [{"drugName":"TIVDAK","activeIngredients":"TISOTUMAB VEDOTIN-TFTV","strength":"40MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"09\/20\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/761208s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"09\/20\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/761208s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/761208Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-09-20
        )

)

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