BRISTOL MYERS SQUIBB FDA Approval BLA 125377

Application #125377

Documents

Letter	2011-03-29
Letter	2012-02-23
Letter	2013-12-09
Letter	2015-03-20
Letter	2015-10-30
Letter	2015-08-19
Label	2011-03-25
Label	2012-10-30
Label	2015-03-24
Label	2016-04-19
Review	2011-05-16
Summary Review	2011-06-08
Letter	2012-10-30
Letter	2013-05-28
Label	2013-05-23
Label	2013-12-06
Label	2015-08-18
Letter	2017-03-08
Label	2017-07-25
Letter	2017-07-25
Letter	2017-10-23
Label	2017-10-24
Label	2017-12-14
Letter	2017-12-18
Pediatric Medical Review	1900-01-01
Pediatric Clinical Pharmacology Review	1900-01-01
Pediatric Written Request	2017-07-20
Pediatric Amendment 1	2017-07-20
Label	2018-02-09
Letter	2018-02-09
Label	2018-04-16
Letter	2018-04-17
Label	2018-07-11
Letter	2018-07-16
Letter	2019-05-13
Label	2019-05-14
Label	2019-09-23
Letter	2019-09-23
Letter	2020-03-11
Label	2020-03-11
Medication Guide	2020-03-11
Label	2020-05-15
Letter	2020-05-19
Label	2020-05-26
Medication Guide	2020-05-26
Letter	2020-05-29
Label	2020-06-30
Medication Guide	2020-06-30
Letter	2020-07-01
Label	2020-08-14
Medication Guide	2020-08-14
Letter	2020-08-14
Letter	2020-09-21
Label	2020-09-22
Medication Guide	2020-09-22
Label	2020-10-02
Letter	2020-10-05
Letter	2020-11-16
Label	2020-11-16
Medication Guide	2020-11-16
Review	2020-12-21
Label	2021-05-24
Medication Guide	2021-05-24
Letter	2021-05-25
Review	2021-12-20
Label	2022-02-28
Medication Guide	2022-02-28
Letter	2022-02-28
Letter	2022-02-28
Label	2022-03-03
Letter	2022-05-12
Label	2022-05-12
Medication Guide	2022-05-12
Letter	2022-05-31
Label	2022-05-31
Medication Guide	2022-05-31
Letter	2022-11-25
Label	2022-11-27
Medication Guide	2022-11-28

Application Sponsors

BLA 125377

BRISTOL MYERS SQUIBB

Marketing Status

Prescription

001

Application Products

001

INJECTABLE; INJECTION

3MG

YERVOY

IPILIMUMAB

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2011-03-25	PRIORITY
LABELING; Labeling	SUPPL	8	AP	2011-07-28	STANDARD
LABELING; Labeling	SUPPL	16	AP	2012-02-16	STANDARD
LABELING; Labeling	SUPPL	33	AP	2012-10-26	STANDARD
LABELING; Labeling	SUPPL	44	AP	2013-05-22	STANDARD
LABELING; Labeling	SUPPL	55	AP	2013-12-05	STANDARD
REMS; REMS	SUPPL	71	AP	2015-03-16	N/A
LABELING; Labeling	SUPPL	72	AP	2015-03-19	STANDARD
EFFICACY; Efficacy	SUPPL	73	AP	2015-10-28	STANDARD
LABELING; Labeling	SUPPL	74	AP	2015-08-17	STANDARD
LABELING; Labeling	SUPPL	84	AP	2017-03-03	STANDARD
EFFICACY; Efficacy	SUPPL	86	AP	2017-10-20	STANDARD
EFFICACY; Efficacy	SUPPL	87	AP	2017-07-21	STANDARD
LABELING; Labeling	SUPPL	91	AP	2017-12-13	STANDARD
LABELING; Labeling	SUPPL	93	AP	2018-02-08	STANDARD
EFFICACY; Efficacy	SUPPL	94	AP	2018-04-16	PRIORITY
EFFICACY; Efficacy	SUPPL	96	AP	2018-07-10	PRIORITY
LABELING; Labeling	SUPPL	102	AP	2019-05-08	STANDARD
LABELING; Labeling	SUPPL	104	AP	2019-09-20	STANDARD
LABELING; Labeling	SUPPL	106	AP	2020-06-29	STANDARD
EFFICACY; Efficacy	SUPPL	108	AP	2020-03-10	PRIORITY
EFFICACY; Efficacy	SUPPL	109	AP	2020-05-15	PRIORITY
EFFICACY; Efficacy	SUPPL	110	AP	2020-05-26	PRIORITY
LABELING; Labeling	SUPPL	111	AP	2020-08-13	STANDARD
EFFICACY; Efficacy	SUPPL	112	AP	2020-09-18	STANDARD
EFFICACY; Efficacy	SUPPL	115	AP	2020-10-02	PRIORITY
LABELING; Labeling	SUPPL	119	AP	2020-11-13	STANDARD
EFFICACY; Efficacy	SUPPL	121	AP	2021-05-23	STANDARD
EFFICACY; Efficacy	SUPPL	122	AP	2022-05-27	STANDARD
EFFICACY; Efficacy	SUPPL	124	AP	2022-05-11	STANDARD
LABELING; Labeling	SUPPL	126	AP	2022-02-25	STANDARD
LABELING; Labeling	SUPPL	127	AP	2022-02-25	STANDARD
LABELING; Labeling	SUPPL	130	AP	2022-11-23	STANDARD

Submissions Property Types

ORIG	1	Null	2
SUPPL	16	Null	7
SUPPL	71	Null	6
SUPPL	72	Null	6
SUPPL	73	Null	7
SUPPL	74	Null	15
SUPPL	84	Null	6
SUPPL	86	Null	15
SUPPL	87	Null	6
SUPPL	91	Null	7
SUPPL	93	Null	6
SUPPL	94	Null	30
SUPPL	96	Null	7
SUPPL	102	Null	6
SUPPL	104	Null	6
SUPPL	106	Null	15
SUPPL	108	Null	6
SUPPL	109	Null	6
SUPPL	110	Null	7
SUPPL	111	Null	6
SUPPL	112	Null	7
SUPPL	115	Null	6
SUPPL	119	Null	6
SUPPL	121	Null	6
SUPPL	122	Null	6
SUPPL	124	Null	7
SUPPL	126	Null	15
SUPPL	127	Null	6
SUPPL	130	Null	6

CDER Filings

BRISTOL MYERS SQUIBB

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 125377
            [companyName] => BRISTOL MYERS SQUIBB
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/125377s112lbl.pdf#page=55"]
            [products] => [{"drugName":"YERVOY","activeIngredients":"IPILIMUMAB","strength":"3MG","dosageForm":"INJECTABLE; INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"10\/02\/2020","submission":"SUPPL-115","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125377s115lbl.pdf\"}]","notes":""},{"actionDate":"09\/18\/2020","submission":"SUPPL-112","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125377s112lbl.pdf\"}]","notes":""},{"actionDate":"08\/13\/2020","submission":"SUPPL-111","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125377s111lbl.pdf\"}]","notes":""},{"actionDate":"06\/29\/2020","submission":"SUPPL-106","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125377s106lbl.pdf\"}]","notes":""},{"actionDate":"05\/26\/2020","submission":"SUPPL-110","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125377s110lbl.pdf\"}]","notes":""},{"actionDate":"05\/15\/2020","submission":"SUPPL-109","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125377s109lbl.pdf\"}]","notes":""},{"actionDate":"03\/10\/2020","submission":"SUPPL-108","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125377s108lbl.pdf\"}]","notes":""},{"actionDate":"09\/20\/2019","submission":"SUPPL-104","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125377s104lbl.pdf\"}]","notes":""},{"actionDate":"05\/08\/2019","submission":"SUPPL-102","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125377s102lbl.pdf\"}]","notes":""},{"actionDate":"07\/10\/2018","submission":"SUPPL-96","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125377s096lbl.pdf\"}]","notes":""},{"actionDate":"04\/16\/2018","submission":"SUPPL-94","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125377s094lbl.pdf\"}]","notes":""},{"actionDate":"02\/08\/2018","submission":"SUPPL-93","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125377s093lbl.pdf\"}]","notes":""},{"actionDate":"12\/13\/2017","submission":"SUPPL-91","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125377s091lbl.pdf\"}]","notes":""},{"actionDate":"10\/20\/2017","submission":"SUPPL-86","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125377s086lbl.pdf\"}]","notes":""},{"actionDate":"07\/21\/2017","submission":"SUPPL-87","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125377s087lbl.pdf\"}]","notes":""},{"actionDate":"10\/28\/2015","submission":"SUPPL-73","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/125377s073lbl.pdf\"}]","notes":""},{"actionDate":"08\/17\/2015","submission":"SUPPL-74","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/125377s074lbl.pdf\"}]","notes":""},{"actionDate":"08\/17\/2015","submission":"SUPPL-74","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/125377s074lbl.pdf\"}]","notes":""},{"actionDate":"03\/19\/2015","submission":"SUPPL-72","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/125377s072lbl.pdf\"}]","notes":""},{"actionDate":"12\/05\/2013","submission":"SUPPL-55","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/125377s055lbl.pdf\"}]","notes":""},{"actionDate":"05\/22\/2013","submission":"SUPPL-44","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/125377s044lbl.pdf\"}]","notes":""},{"actionDate":"10\/26\/2012","submission":"SUPPL-33","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/125377s033lbl.pdf\"}]","notes":""},{"actionDate":"03\/25\/2011","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/125377s0000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"03\/25\/2011","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/125377s0000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2011\\\/125377s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2011\\\/125377Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2011\\\/125377Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"10\/02\/2020","submission":"SUPPL-115","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125377s115lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/125377Orig1s115ltr.pdf\"}]","notes":">"},{"actionDate":"09\/18\/2020","submission":"SUPPL-112","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125377s112lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/125377Orig1s112ltr.pdf\"}]","notes":">"},{"actionDate":"08\/13\/2020","submission":"SUPPL-111","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125377s111lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/125377Orig1s111ltr.pdf\"}]","notes":">"},{"actionDate":"05\/26\/2020","submission":"SUPPL-110","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125377s110lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/125377Orig1s110ltr.pdf\"}]","notes":">"},{"actionDate":"05\/15\/2020","submission":"SUPPL-109","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125377s109lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/125377Orig1s109ltr.pdf\"}]","notes":">"},{"actionDate":"03\/10\/2020","submission":"SUPPL-108","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125377s108lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/125377Orig1s108ltr.pdf\"}]","notes":">"},{"actionDate":"06\/29\/2020","submission":"SUPPL-106","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125377s106lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/125377Orig1s106ltr.pdf\"}]","notes":">"},{"actionDate":"09\/20\/2019","submission":"SUPPL-104","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125377s104lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/125377Orig1s104ltr.pdf\"}]","notes":">"},{"actionDate":"05\/08\/2019","submission":"SUPPL-102","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125377s102lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/125377Orig1s102ltr.pdf\"}]","notes":">"},{"actionDate":"07\/10\/2018","submission":"SUPPL-96","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125377s096lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/125377Orig1s096ltr.pdf\"}]","notes":">"},{"actionDate":"04\/16\/2018","submission":"SUPPL-94","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125377s094lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/125377Orig1s094ltr.pdf\"}]","notes":">"},{"actionDate":"02\/08\/2018","submission":"SUPPL-93","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125377s093lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/125377Orig1s093ltr.pdf\"}]","notes":">"},{"actionDate":"12\/13\/2017","submission":"SUPPL-91","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125377s091lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/125377Orig1s091ltr.pdf\"}]","notes":">"},{"actionDate":"07\/21\/2017","submission":"SUPPL-87","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125377s087lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/125377Orig1s087ltr.pdf\"}]","notes":">"},{"actionDate":"10\/20\/2017","submission":"SUPPL-86","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125377s086lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/125377Orig1s086ltr.pdf\"}]","notes":">"},{"actionDate":"03\/03\/2017","submission":"SUPPL-84","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/125377Orig1s084ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"08\/17\/2015","submission":"SUPPL-74","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/125377s074lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/125377Orig1s074ltr.pdf\"}]","notes":">"},{"actionDate":"10\/28\/2015","submission":"SUPPL-73","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/125377s073lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/125377Orig1s073ltr.pdf\"}]","notes":">"},{"actionDate":"03\/19\/2015","submission":"SUPPL-72","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/125377s072lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/125377Orig1s072ltr.pdf\"}]","notes":">"},{"actionDate":"03\/16\/2015","submission":"SUPPL-71","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/05\/2013","submission":"SUPPL-55","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/125377s055lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/125377Orig1s055ltr.pdf\"}]","notes":">"},{"actionDate":"05\/22\/2013","submission":"SUPPL-44","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/125377s044lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/125377Orig1s044ltr.pdf\"}]","notes":">"},{"actionDate":"10\/26\/2012","submission":"SUPPL-33","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/125377s033lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/125377Orig1s033ltr.pdf\"}]","notes":">"},{"actionDate":"02\/16\/2012","submission":"SUPPL-16","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/125377s016ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"07\/28\/2011","submission":"SUPPL-8","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-10-02
        )

)

BLA 125377

BRISTOL MYERS SQUIBB

FDA Drug Application

Application #125377

Documents

Application Sponsors

Marketing Status

Application Products

FDA Submissions

Submissions Property Types

CDER Filings

BRISTOL MYERS SQUIBB