Documents
Application Sponsors
BLA 125377 | BRISTOL MYERS SQUIBB | |
Marketing Status
Application Products
001 | INJECTABLE; INJECTION | 3MG | 0 | 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 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(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
)
)