IMMUNOCORE LTD FDA Approval BLA 761228

BLA 761228

IMMUNOCORE LTD

FDA Drug Application

Application #761228

Documents

Label2022-01-26
Letter2022-01-27
Review2022-02-23

Application Sponsors

BLA 761228IMMUNOCORE LTD

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION100MCG/0.5ML0KIMMTRAKTEBENTAFUSP-TEBN

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2022-01-25PRIORITY

Submissions Property Types

ORIG1Null30

CDER Filings

IMMUNOCORE LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761228
            [companyName] => IMMUNOCORE LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"KIMMTRAK","activeIngredients":"TEBENTAFUSP-TEBN","strength":"100MCG\/0.5ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"01\/25\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/761228s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"01\/25\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/761228s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/761228Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-01-25
        )

)

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