Documents
Application Sponsors
BLA 125554 | BRISTOL MYERS SQUIBB | |
Marketing Status
Application Products
001 | INJECTABLE;INJECTION | 40MG/4ML | 2 | OPDIVO | NIVOLUMAB |
FDA Submissions
TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2014-12-22 | PRIORITY |
EFFICACY; Efficacy | SUPPL | 2 | AP | 2015-09-30 | PRIORITY |
LABELING; Labeling | SUPPL | 3 | AP | 2015-04-14 | STANDARD |
LABELING; Labeling | SUPPL | 4 | AP | 2015-04-14 | STANDARD |
EFFICACY; Efficacy | SUPPL | 5 | AP | 2015-10-09 | PRIORITY |
EFFICACY; Efficacy | SUPPL | 7 | AP | 2016-01-23 | PRIORITY |
EFFICACY; Efficacy | SUPPL | 12 | AP | 2015-11-23 | PRIORITY |
EFFICACY; Efficacy | SUPPL | 16 | AP | 2016-10-04 | STANDARD |
EFFICACY; Efficacy | SUPPL | 17 | AP | 2016-09-13 | STANDARD |
EFFICACY; Efficacy | SUPPL | 18 | AP | 2016-09-13 | STANDARD |
EFFICACY; Efficacy | SUPPL | 19 | AP | 2016-05-17 | PRIORITY |
EFFICACY; Efficacy | SUPPL | 22 | AP | 2016-11-10 | PRIORITY |
EFFICACY; Efficacy | SUPPL | 24 | AP | 2017-02-02 | PRIORITY |
EFFICACY; Efficacy | SUPPL | 31 | AP | 2017-04-25 | PRIORITY |
EFFICACY; Efficacy | SUPPL | 34 | AP | 2017-07-31 | PRIORITY |
EFFICACY; Efficacy | SUPPL | 35 | AP | 2018-01-09 | STANDARD |
EFFICACY; Efficacy | SUPPL | 36 | AP | 2018-01-09 | STANDARD |
EFFICACY; Efficacy | SUPPL | 37 | AP | 2018-01-09 | STANDARD |
EFFICACY; Efficacy | SUPPL | 38 | AP | 2018-01-09 | STANDARD |
EFFICACY; Efficacy | SUPPL | 39 | AP | 2018-01-09 | STANDARD |
LABELING; Labeling | SUPPL | 40 | AP | 2017-09-06 | STANDARD |
EFFICACY; Efficacy | SUPPL | 41 | AP | 2017-09-22 | PRIORITY |
EFFICACY; Efficacy | SUPPL | 42 | AP | 2019-03-07 | PRIORITY |
EFFICACY; Efficacy | SUPPL | 44 | AP | 2018-02-15 | STANDARD |
EFFICACY; Efficacy | SUPPL | 45 | AP | 2018-02-15 | STANDARD |
EFFICACY; Efficacy | SUPPL | 48 | AP | 2018-03-05 | STANDARD |
EFFICACY; Efficacy | SUPPL | 49 | AP | 2018-03-05 | STANDARD |
EFFICACY; Efficacy | SUPPL | 50 | AP | 2018-03-05 | STANDARD |
EFFICACY; Efficacy | SUPPL | 51 | AP | 2018-03-05 | STANDARD |
EFFICACY; Efficacy | SUPPL | 52 | AP | 2018-03-05 | STANDARD |
EFFICACY; Efficacy | SUPPL | 55 | AP | 2017-12-20 | PRIORITY |
LABELING; Labeling | SUPPL | 56 | AP | 2018-02-13 | STANDARD |
EFFICACY; Efficacy | SUPPL | 58 | AP | 2018-04-16 | PRIORITY |
EFFICACY; Efficacy | SUPPL | 61 | AP | 2018-03-05 | STANDARD |
EFFICACY; Efficacy | SUPPL | 62 | AP | 2018-03-05 | STANDARD |
EFFICACY; Efficacy | SUPPL | 63 | AP | 2018-07-10 | PRIORITY |
EFFICACY; Efficacy | SUPPL | 64 | AP | 2018-03-05 | STANDARD |
EFFICACY; Efficacy | SUPPL | 65 | AP | 2018-03-05 | STANDARD |
EFFICACY; Efficacy | SUPPL | 66 | AP | 2018-03-05 | STANDARD |
EFFICACY; Efficacy | SUPPL | 67 | AP | 2018-08-16 | PRIORITY |
LABELING; Labeling | SUPPL | 69 | AP | 2018-11-15 | STANDARD |
EFFICACY; Efficacy | SUPPL | 70 | AP | 2019-04-18 | STANDARD |
LABELING; Labeling | SUPPL | 71 | AP | 2020-11-10 | STANDARD |
LABELING; Labeling | SUPPL | 72 | AP | 2019-02-01 | STANDARD |
LABELING; Labeling | SUPPL | 73 | AP | 2019-05-02 | STANDARD |
LABELING; Labeling | SUPPL | 75 | AP | 2019-09-18 | STANDARD |
EFFICACY; Efficacy | SUPPL | 78 | AP | 2020-03-10 | PRIORITY |
EFFICACY; Efficacy | SUPPL | 80 | AP | 2020-05-15 | PRIORITY |
EFFICACY; Efficacy | SUPPL | 81 | AP | 2020-06-10 | PRIORITY |
EFFICACY; Efficacy | SUPPL | 82 | AP | 2020-05-26 | PRIORITY |
LABELING; Labeling | SUPPL | 83 | AP | 2020-06-23 | STANDARD |
EFFICACY; Efficacy | SUPPL | 84 | AP | 2020-09-18 | STANDARD |
EFFICACY; Efficacy | SUPPL | 85 | AP | 2020-09-18 | STANDARD |
LABELING; Labeling | SUPPL | 86 | AP | 2020-09-25 | STANDARD |
EFFICACY; Efficacy | SUPPL | 89 | AP | 2020-10-02 | PRIORITY |
EFFICACY; Efficacy | SUPPL | 90 | AP | 2021-01-22 | PRIORITY |
EFFICACY; Efficacy | SUPPL | 91 | AP | 2021-04-16 | PRIORITY |
EFFICACY; Efficacy | SUPPL | 92 | AP | 2021-05-20 | PRIORITY |
LABELING; Labeling | SUPPL | 95 | AP | 2020-12-29 | STANDARD |
EFFICACY; Efficacy | SUPPL | 97 | AP | 2021-08-19 | PRIORITY |
LABELING; Labeling | SUPPL | 98 | AP | 2021-03-30 | STANDARD |
EFFICACY; Efficacy | SUPPL | 99 | AP | 2021-07-15 | STANDARD |
EFFICACY; Efficacy | SUPPL | 105 | AP | 2022-05-27 | STANDARD |
EFFICACY; Efficacy | SUPPL | 106 | AP | 2022-05-27 | STANDARD |
LABELING; Labeling | SUPPL | 107 | AP | 2021-07-23 | STANDARD |
EFFICACY; Efficacy | SUPPL | 108 | AP | 2022-05-11 | STANDARD |
LABELING; Labeling | SUPPL | 109 | AP | 2022-02-25 | STANDARD |
EFFICACY; Efficacy | SUPPL | 112 | AP | 2022-03-04 | PRIORITY |
EFFICACY; Efficacy | SUPPL | 114 | AP | 2022-07-14 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 7 |
SUPPL | 2 | Null | 7 |
SUPPL | 5 | Null | 6 |
SUPPL | 7 | Null | 15 |
SUPPL | 12 | Null | 15 |
SUPPL | 16 | Null | 6 |
SUPPL | 17 | Null | 7 |
SUPPL | 18 | Null | 7 |
SUPPL | 19 | Null | 15 |
SUPPL | 22 | Null | 7 |
SUPPL | 24 | Null | 7 |
SUPPL | 31 | Null | 7 |
SUPPL | 34 | Null | 6 |
SUPPL | 35 | Null | 6 |
SUPPL | 36 | Null | 7 |
SUPPL | 37 | Null | 15 |
SUPPL | 38 | Null | 6 |
SUPPL | 39 | Null | 6 |
SUPPL | 40 | Null | 6 |
SUPPL | 41 | Null | 7 |
SUPPL | 42 | Null | 7 |
SUPPL | 44 | Null | 7 |
SUPPL | 45 | Null | 15 |
SUPPL | 48 | Null | 7 |
SUPPL | 49 | Null | 7 |
SUPPL | 50 | Null | 7 |
SUPPL | 51 | Null | 15 |
SUPPL | 52 | Null | 6 |
SUPPL | 55 | Null | 7 |
SUPPL | 56 | Null | 15 |
SUPPL | 58 | Null | 30 |
SUPPL | 61 | Null | 6 |
SUPPL | 62 | Null | 7 |
SUPPL | 63 | Null | 7 |
SUPPL | 64 | Null | 15 |
SUPPL | 65 | Null | 6 |
SUPPL | 66 | Null | 6 |
SUPPL | 67 | Null | 6 |
SUPPL | 69 | Null | 7 |
SUPPL | 70 | Null | 7 |
SUPPL | 71 | Null | 6 |
SUPPL | 72 | Null | 7 |
SUPPL | 73 | Null | 7 |
SUPPL | 75 | Null | 7 |
SUPPL | 78 | Null | 6 |
SUPPL | 80 | Null | 15 |
SUPPL | 81 | Null | 6 |
SUPPL | 82 | Null | 2 |
SUPPL | 83 | Null | 7 |
SUPPL | 84 | Null | 15 |
SUPPL | 85 | Null | 6 |
SUPPL | 86 | Null | 6 |
SUPPL | 89 | Null | 7 |
SUPPL | 90 | Null | 2 |
SUPPL | 91 | Null | 7 |
SUPPL | 92 | Null | 15 |
SUPPL | 95 | Orphan | 5 |
SUPPL | 97 | Null | 7 |
SUPPL | 98 | Null | 15 |
SUPPL | 99 | Null | 6 |
SUPPL | 105 | Null | 6 |
SUPPL | 106 | Null | 6 |
SUPPL | 107 | Null | 7 |
SUPPL | 108 | Null | 7 |
SUPPL | 109 | Null | 15 |
SUPPL | 112 | Null | 6 |
SUPPL | 114 | Null | 7 |
CDER Filings
BRISTOL MYERS SQUIBB
cder:Array
(
[0] => Array
(
[ApplNo] => 125554
[companyName] => BRISTOL MYERS SQUIBB
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/125554s083lbl.pdf#page=95"]
[products] => [{"drugName":"OPDIVO","activeIngredients":"NIVOLUMAB","strength":"40MG\/4ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
[labels] => [{"actionDate":"06\/23\/2020","submission":"SUPPL-83","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125554s083lbl.pdf\"}]","notes":""},{"actionDate":"06\/10\/2020","submission":"SUPPL-81","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125554s081lbl.pdf\"}]","notes":""},{"actionDate":"05\/26\/2020","submission":"SUPPL-82","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125554s082lbl.pdf\"}]","notes":""},{"actionDate":"05\/15\/2020","submission":"SUPPL-80","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label 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(PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125554s072lbl.pdf\"}]","notes":""},{"actionDate":"11\/15\/2018","submission":"SUPPL-69","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125554s069lbl.pdf\"}]","notes":""},{"actionDate":"08\/16\/2018","submission":"SUPPL-67","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125554s067lbl.pdf\"}]","notes":""},{"actionDate":"07\/10\/2018","submission":"SUPPL-63","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125554s063lbl.pdf\"}]","notes":""},{"actionDate":"04\/16\/2018","submission":"SUPPL-58","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125554s058lbl.pdf\"}]","notes":""},{"actionDate":"03\/05\/2018","submission":"SUPPL-66","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125554s048s049s050s051s052s061s062s064s065s066lbl.pdf\"}]","notes":""},{"actionDate":"03\/05\/2018","submission":"SUPPL-65","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label 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(PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/125554s012lbl.pdf\"}]","notes":""},{"actionDate":"11\/23\/2015","submission":"SUPPL-1","supplementCategories":"Efficacy-Accelerated Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/125554s001lbl.pdf\"}]","notes":""},{"actionDate":"10\/09\/2015","submission":"SUPPL-5","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/125554s005lbl.pdf\"}]","notes":""},{"actionDate":"09\/30\/2015","submission":"SUPPL-2","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/125554s002lbl.pdf\"}]","notes":""},{"actionDate":"12\/22\/2014","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/125554lbl.pdf\"}]","notes":""}]
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[actionDate] => 2020-06-23
)
)