BRISTOL-MYERS SQUIBB FDA Approval BLA 225554

BLA 225554

BRISTOL-MYERS SQUIBB

FDA Drug Application

Application #225554

Documents

Label2022-03-07

Application Sponsors

BLA 225554BRISTOL-MYERS SQUIBB

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001INJECTABLE;INJECTION, SOLUTION40MG/4ML0OPDIVONIVOLUMAB
002INJECTABLE;INJECTION, SOLUTION100MG/10ML0OPDIVONIVOLUMAB
003INJECTABLE;INJECTION, SOLUTION120MG/12ML0OPDIVONIVOLUMAB
004INJECTABLE;INJECTION, SOLUTION240MG/124ML0OPDIVONIVOLUMAB

FDA Submissions

EFFICACY; EfficacyORIG1AP2022-03-04PRIORITY

CDER Filings

BRISTOL-MYERS SQUIBB
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 225554
            [companyName] => BRISTOL-MYERS SQUIBB
            [docInserts] => ["",""]
            [products] => [{"drugName":"OPDIVO","activeIngredients":"NIVOLUMAB","strength":"40MG\/4ML","dosageForm":"INJECTABLE;INJECTION, SOLUTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"OPDIVO","activeIngredients":"NIVOLUMAB","strength":"100MG\/10ML","dosageForm":"INJECTABLE;INJECTION, SOLUTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"OPDIVO","activeIngredients":"NIVOLUMAB","strength":"120MG\/12ML","dosageForm":"INJECTABLE;INJECTION, SOLUTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"OPDIVO","activeIngredients":"NIVOLUMAB","strength":"240MG\/124ML","dosageForm":"INJECTABLE;INJECTION, SOLUTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"03\/04\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/225554s112lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"03\/04\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/225554s112lbl.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-03-04
        )

)

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