BRISTOL MYERS SQUIBB FDA Approval BLA 125554

Application #125554

Documents

Letter	2014-12-24
Letter	2015-11-24
Letter	2015-10-14
Label	2016-05-17
Summary Review	2015-01-21
Letter	2016-01-25
Letter	2015-11-24
Letter	2016-05-19
Label	2014-12-22
Label	2015-11-25
Label	2015-10-09
Label	2015-11-23
Review	2015-01-21
Letter	2016-09-15
Letter	2016-09-15
Label	2016-09-28
Label	2016-09-28
Label	2016-10-06
Letter	2016-10-06
Label	2015-10-01
Letter	2015-10-02
Letter	2016-11-15
Label	2016-11-10
Label	2017-02-02
Letter	2017-02-03
Label	2017-04-26
Letter	2017-04-27
Label	2017-08-01
Letter	2017-08-02
Label	2017-09-07
Letter	2017-09-08
Label	2017-09-22
Letter	2017-09-25
Label	2017-12-20
Letter	2017-12-27
Label	2018-01-09
Letter	2018-01-11
Letter	2018-01-11
Letter	2018-01-11
Letter	2018-01-11
Letter	2018-01-11
Label	2018-02-14
Letter	2018-02-14
Label	2018-02-16
Label	2018-02-16
Letter	2018-02-23
Letter	2018-02-23
Label	2018-03-06
Label	2018-03-06
Label	2018-03-06
Label	2018-03-06
Label	2018-03-06
Label	2018-03-06
Label	2018-03-06
Label	2018-03-06
Label	2018-03-06
Label	2018-03-06
Letter	2018-03-12
Letter	2018-03-12
Letter	2018-03-12
Letter	2018-03-12
Letter	2018-03-12
Letter	2018-03-12
Letter	2018-03-12
Letter	2018-03-12
Letter	2018-03-12
Letter	2018-03-12
Label	2018-04-16
Letter	2018-04-17
Label	2018-07-11
Letter	2018-07-16
Label	2018-08-17
Letter	2018-08-20
Letter	2018-11-20
Label	2018-11-23
Label	2019-02-04
Letter	2019-02-13
Letter	2019-03-08
Label	2019-03-08
Label	2019-04-24
Letter	2019-04-24
Label	2019-05-03
Letter	2019-05-03
Label	2019-09-19
Medication Guide	2019-09-19
Letter	2019-09-19
Letter	2020-03-11
Label	2020-03-11
Medication Guide	2020-03-11
Review	2020-03-24
Review	2020-03-24
Review	2020-03-24
Review	2020-03-24
Review	2020-03-24
Review	2020-03-24
Review	2020-03-24
Review	2018-03-05
Review	2018-03-05
Review	2018-03-05
Label	2020-05-15
Letter	2020-05-19
Pediatric DD Summary Review	1900-01-01
Pediatric Medical Review	1900-01-01
Pediatric Clinical Pharmacology Review	1900-01-01
Pediatric Other	1900-01-01
Label	2020-05-26
Medication Guide	2020-05-26
Letter	2020-05-29
Review	2020-06-01
Label	2020-06-11
Medication Guide	2020-06-11
Letter	2020-06-12
Label	2020-06-24
Medication Guide	2020-06-24
Letter	2020-06-24
Letter	2020-09-21
Letter	2020-09-21
Review	2020-09-24
Label	2020-09-25
Medication Guide	2020-09-25
Letter	2020-09-28
Label	2020-09-29
Medication Guide	2020-09-29
Label	2020-10-02
Letter	2020-10-05
Letter	2020-11-12
Label	2020-11-13
Medication Guide	2020-11-13
Review	2020-12-21
Letter	2020-12-30
Label	2020-12-31
Medication Guide	2020-12-31
Label	2021-01-22
Medication Guide	2021-01-22
Letter	2021-01-26
Review	2021-02-23
Review	2021-02-23
Letter	2021-03-31
Label	2021-04-16
Medication Guide	2021-04-16
Letter	2021-04-19
Label	2021-05-20
Label	2021-05-20
Medication Guide	2021-05-20
Letter	2021-05-24
Letter	2021-07-19
Label	2021-07-20
Label	2021-07-26
Medication Guide	2021-07-26
Letter	2021-07-27
Label	2021-08-20
Letter	2021-08-24
Letter	2022-02-28
Label	2022-03-02
Medication Guide	2022-03-02
Letter	2022-03-07
Label	2022-03-10
Medication Guide	2022-03-10
Letter	2022-05-12
Label	2022-05-12
Medication Guide	2022-05-12
Letter	2022-05-31
Letter	2022-05-31
Label	2022-05-31
Medication Guide	2022-05-31
Label	2022-05-31
Letter	2022-07-15
Label	2022-07-15
Medication Guide	2022-07-15

Application Sponsors

BLA 125554

BRISTOL MYERS SQUIBB

Marketing Status

Prescription

001

Application Products

001

INJECTABLE;INJECTION

40MG/4ML

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 (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125554s080lbl.pdf\"}]","notes":""},{"actionDate":"03\/10\/2020","submission":"SUPPL-78","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125554s078lbl.pdf\"}]","notes":""},{"actionDate":"09\/18\/2019","submission":"SUPPL-75","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125554s075lbl.pdf\"}]","notes":""},{"actionDate":"05\/02\/2019","submission":"SUPPL-73","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125554s073lbl.pdf\"}]","notes":""},{"actionDate":"04\/18\/2019","submission":"SUPPL-70","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125554s070lbl.pdf\"}]","notes":""},{"actionDate":"03\/07\/2019","submission":"SUPPL-42","supplementCategories":"Efficacy-Accelerated Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125554s042lbl.pdf\"}]","notes":""},{"actionDate":"02\/01\/2019","submission":"SUPPL-72","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (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 (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125554s048s049s050s051s052s061s062s064s065s066lbl.pdf\"}]","notes":""},{"actionDate":"03\/05\/2018","submission":"SUPPL-64","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-62","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-61","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125554s061lbl.pdf\"}]","notes":""},{"actionDate":"03\/05\/2018","submission":"SUPPL-52","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-51","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-50","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-49","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-48","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125554s048s049s050s051s052s061s062s064s065s066lbl.pdf\"}]","notes":""},{"actionDate":"02\/15\/2018","submission":"SUPPL-45","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125554s044s045lbl.pdf\"}]","notes":""},{"actionDate":"02\/15\/2018","submission":"SUPPL-44","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125554s044s045lbl.pdf\"}]","notes":""},{"actionDate":"02\/13\/2018","submission":"SUPPL-56","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125554s056lbl.pdf\"}]","notes":""},{"actionDate":"01\/09\/2018","submission":"SUPPL-35","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125554s035s036s037s038s039lbl.pdf\"}]","notes":""},{"actionDate":"12\/20\/2017","submission":"SUPPL-55","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125554s055lbl.pdf\"}]","notes":""},{"actionDate":"09\/22\/2017","submission":"SUPPL-41","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125554s041lbl.pdf\"}]","notes":""},{"actionDate":"09\/06\/2017","submission":"SUPPL-40","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label 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(PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125554s031lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/125554Orig1s031ltr.pdf\"}]","notes":">"},{"actionDate":"02\/02\/2017","submission":"SUPPL-24","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125554s024lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/125554Orig1s024ltr.pdf\"}]","notes":">"},{"actionDate":"11\/10\/2016","submission":"SUPPL-22","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/125554s022lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/125554Orig1s022ltr.pdf\"}]","notes":">"},{"actionDate":"05\/17\/2016","submission":"SUPPL-19","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/125554s019lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/125554Orig1s019ltr.pdf\"}]","notes":">"},{"actionDate":"09\/13\/2016","submission":"SUPPL-18","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/125554s017s018lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/125554Orig1s017,s018ltr.pdf\"}]","notes":">"},{"actionDate":"09\/13\/2016","submission":"SUPPL-17","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/125554s017s018lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/125554Orig1s017,s018ltr.pdf\"}]","notes":">"},{"actionDate":"10\/04\/2016","submission":"SUPPL-16","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/125554s016lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/125554Orig1s016ltr.pdf\"}]","notes":">"},{"actionDate":"11\/23\/2015","submission":"SUPPL-12","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/125554s012lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/125554Orig1s012ltr.pdf\"}]","notes":">"},{"actionDate":"01\/23\/2016","submission":"SUPPL-7","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/125554Orig1s007ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"10\/09\/2015","submission":"SUPPL-5","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/125554s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/125554Orig1s005ltr.pdf\"}]","notes":">"},{"actionDate":"09\/30\/2015","submission":"SUPPL-2","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/125554s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/125554Orig1s002ltr.pdf\"}]","notes":">"},{"actionDate":"11\/23\/2015","submission":"SUPPL-1","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/125554s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/125554Orig1s001ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2020-06-23
        )

)

BLA 125554

BRISTOL MYERS SQUIBB

FDA Drug Application

Application #125554

Documents

Application Sponsors

Marketing Status

Application Products

FDA Submissions

Submissions Property Types

CDER Filings

BRISTOL MYERS SQUIBB