BLA 761234

BRISTOL MYERS SQUIBB

FDA Drug Application

Application #761234

Documents

• Label: 2022-03-18
• Medication Guide: 2022-03-18
• Letter: 2022-03-21
• Review: 2022-04-15

Application Sponsors

BLA 761234

BRISTOL MYERS SQUIBB

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INTRAVENOUS

240MG;80MG

0

OPDUALAG

NIVOLUMAB;ELATLIMAB-RMBW

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity

ORIG

1

AP

2022-03-18

PRIORITY

Submissions Property Types

ORIG

1

Null

6

CDER Filings

BRISTOL MYERS SQUIBB

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761234
            [companyName] => BRISTOL MYERS SQUIBB
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2022\/761234s000lbl.pdf#page=23"]
            [products] => [{"drugName":"OPDUALAG","activeIngredients":"NIVOLUMAB;ELATLIMAB-RMBW","strength":"240MG;80MG","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"03\/18\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/761234s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"03\/18\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/761234s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/761234Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-03-18
        )

)