BLA 225554

BRISTOL-MYERS SQUIBB

FDA Drug Application

Application #225554

Documents

• Label: 2022-03-07

Application Sponsors

BLA 225554

BRISTOL-MYERS SQUIBB

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	INJECTABLE;INJECTION, SOLUTION	40MG/4ML	0	OPDIVO	NIVOLUMAB
002	INJECTABLE;INJECTION, SOLUTION	100MG/10ML	0	OPDIVO	NIVOLUMAB
003	INJECTABLE;INJECTION, SOLUTION	120MG/12ML	0	OPDIVO	NIVOLUMAB
004	INJECTABLE;INJECTION, SOLUTION	240MG/124ML	0	OPDIVO	NIVOLUMAB

FDA Submissions

EFFICACY; Efficacy

ORIG

1

AP

2022-03-04

PRIORITY

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
        )

)