IMMUNOMEDICS INC FDA Approval BLA 761115

BLA 761115

IMMUNOMEDICS INC

FDA Drug Application

Application #761115

Documents

Label2020-04-22
Letter2020-04-23
Review2020-05-19

Application Sponsors

BLA 761115IMMUNOMEDICS INC

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION180MG2TRODELVYSACITUZUMAB GOVITECAN-HZIY

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2020-04-22PRIORITY

Submissions Property Types

ORIG1Null7

CDER Filings

IMMUNOMEDICS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761115
            [companyName] => IMMUNOMEDICS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRODELVY","activeIngredients":"SACITUZUMAB GOVITECAN-HZIY","strength":"180MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"04\/22\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761115s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"04\/22\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761115s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/761115Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2020\\\/761115Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-04-22
        )

)

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.