DAIICHI SANKYO FDA Approval BLA 761139

BLA 761139

DAIICHI SANKYO

FDA Drug Application

Application #761139

Documents

Label2019-12-20
Letter2020-01-15
Review2020-01-17

Application Sponsors

BLA 761139DAIICHI SANKYO

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION100MG2ENHERTUFAM-TRASTUZUMAB DERUXTECAN-NXKI

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2019-12-20PRIORITY

Submissions Property Types

ORIG1Null6

CDER Filings

DAIICHI SANKYO
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761139
            [companyName] => DAIICHI SANKYO
            [docInserts] => ["",""]
            [products] => [{"drugName":"ENHERTU","activeIngredients":"FAM-TRASTUZUMAB DERUXTECAN-NXKI","strength":"100MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"12\/20\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761139s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"12\/20\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761139s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/761139Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/761139Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2019-12-20
        )

)

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