ASTRAZENECA AB FDA Approval BLA 761289

BLA 761289

ASTRAZENECA AB

FDA Drug Application

Application #761289

Documents

Letter2022-10-24
Letter2022-10-31
Label2022-10-31
Medication Guide2022-10-31
Letter2022-11-01
Label2022-11-01
Medication Guide2022-11-01
Review2022-11-04

Application Sponsors

BLA 761289ASTRAZENECA AB

Marketing Status

Prescription001
Prescription002

Application Products

001INJECTABLE;INTRAVENOUS25MG/1.25ML(20MG/ML)0IMJUDOTREMELIMUMAB-ACTL
002INJECTABLE;INTRAVENOUS300MG/15ML(20MG/ML)0IMJUDOTREMELIMUMAB-ACTL

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2022-10-21PRIORITY

Submissions Property Types

ORIG1Null40

CDER Filings

ASTRAZENECA AB
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761289
            [companyName] => ASTRAZENECA AB
            [docInserts] => ["",""]
            [products] => [{"drugName":"IMJUDO","activeIngredients":"TREMELIMUMAB-ACTL","strength":"25MG\/1.25ML(20MG\/ML)","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"IMJUDO","activeIngredients":"TREMELIMUMAB-ACTL","strength":"300MG\/15ML(20MG\/ML)","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/21\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A; Orphan","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/761289Orig1s001ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-10-21
        )

)

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