BLA 125527

BRISTOL MYERS SQUIBB

FDA Drug Application

Application #125527

Documents

• Letter: 2015-03-05
• Label: 2015-03-04
• Review: 2016-09-30

Application Sponsors

BLA 125527

BRISTOL MYERS SQUIBB

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE;INJECTION	40MG/4ML	0	OPDIVO	NIVOLUMAB
002	INJECTABLE;INJECTION	100MG/10ML	0	OPDIVO	NIVOLUMAB

FDA Submissions

TYPE 9- BLA; Type 9 - New indication submitted as distinct BLA, consolidated

ORIG

1

AP

2015-03-04

PRIORITY

Submissions Property Types

ORIG

1

Null

40

CDER Filings

BRISTOL MYERS SQUIBB

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 125527
            [companyName] => BRISTOL MYERS SQUIBB
            [docInserts] => ["",""]
            [products] => [{"drugName":"OPDIVO","activeIngredients":"NIVOLUMAB","strength":"40MG\/4ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"OPDIVO","activeIngredients":"NIVOLUMAB","strength":"100MG\/10ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"03\/04\/2015","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/125527s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"03\/04\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/125527s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/125527Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/125527Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2015-03-04
        )

)