ASTRAZENECA AB FDA Approval BLA 761123

BLA 761123

ASTRAZENECA AB

FDA Drug Application

Application #761123

Documents

Label2021-08-02
Letter2021-08-02
Review2021-08-17

Application Sponsors

BLA 761123ASTRAZENECA AB

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION300MG/2ML(150MG/ML)0SAPHNELOANIFROLUMAB-FNIA

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2021-07-30STANDARD

Submissions Property Types

ORIG1Null7

CDER Filings

ASTRAZENECA AB
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761123
            [companyName] => ASTRAZENECA AB
            [docInserts] => ["",""]
            [products] => [{"drugName":"SAPHNELO","activeIngredients":"ANIFROLUMAB-FNIA","strength":"300MG\/2ML(150MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"07\/30\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/761123s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"07\/30\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/761123s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/761123Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-07-30
        )

)

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