BRISTOL MYERS SQUIBB FDA Approval BLA 125288

BLA 125288

BRISTOL MYERS SQUIBB

FDA Drug Application

Application #125288

Documents

Letter2011-06-24
Letter2013-04-10
Letter2014-10-02
Label2013-04-09
Label2014-10-02
Review2011-08-08
Letter2014-04-16
Label2011-06-16
Label2014-04-16
Letter2017-02-01
Label2017-02-06
Letter2017-05-12
Letter2017-11-13
Label2017-11-13
Label2018-04-13
Medication Guide2018-04-13
Letter2018-04-16
Letter2021-07-29
Label2021-07-29

Application Sponsors

BLA 125288BRISTOL MYERS SQUIBB

Marketing Status

Prescription001

Application Products

001INJECTABLE; INJECTION250MG0NULOJIXBELATACEPT

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2011-06-15STANDARD
LABELING; LabelingSUPPL30AP2013-04-08STANDARD
LABELING; LabelingSUPPL59AP2014-04-15STANDARD
LABELING; LabelingSUPPL62AP2014-09-30STANDARD
LABELING; LabelingSUPPL70AP2017-02-02STANDARD
REMS; REMSSUPPL72AP2017-05-09N/A
LABELING; LabelingSUPPL74AP2017-11-09STANDARD
EFFICACY; EfficacySUPPL75AP2018-04-13STANDARD
LABELING; LabelingSUPPL101AP2021-07-28STANDARD

Submissions Property Types

ORIG1Orphan5
SUPPL62Null7
SUPPL70Null7
SUPPL72Null7
SUPPL74Null6
SUPPL75Null6
SUPPL101Null6

CDER Filings

BRISTOL MYERS SQUIBB
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 125288
            [companyName] => BRISTOL MYERS SQUIBB
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2018\/125288s075lbl.pdf#page=49"]
            [products] => [{"drugName":"NULOJIX","activeIngredients":"BELATACEPT","strength":"250MG","dosageForm":"INJECTABLE; INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"04\/13\/2018","submission":"SUPPL-75","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125288s075lbl.pdf\"}]","notes":""},{"actionDate":"11\/09\/2017","submission":"SUPPL-74","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125288s074lbl.pdf\"}]","notes":""},{"actionDate":"11\/09\/2017","submission":"SUPPL-74","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125288s074lbl.pdf\"}]","notes":""},{"actionDate":"02\/02\/2017","submission":"SUPPL-70","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125288s070lbl.pdf\"}]","notes":""},{"actionDate":"09\/30\/2014","submission":"SUPPL-62","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/125288s062lbl.pdf\"}]","notes":""},{"actionDate":"04\/15\/2014","submission":"SUPPL-59","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/125288s059lbl.pdf\"}]","notes":""},{"actionDate":"04\/08\/2013","submission":"SUPPL-30","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/125288s030lbl.pdf\"}]","notes":""},{"actionDate":"06\/15\/2011","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/125288s0000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"06\/15\/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\\\/125288s0000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2011\\\/125288s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2011\\\/125288Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"04\/13\/2018","submission":"SUPPL-75","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125288s075lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/125288Orig1s075ltr.pdf\"}]","notes":">"},{"actionDate":"11\/09\/2017","submission":"SUPPL-74","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125288s074lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/125288Orig1s074ltr.pdf\"}]","notes":">"},{"actionDate":"05\/09\/2017","submission":"SUPPL-72","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/125288Orig1s072ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"02\/02\/2017","submission":"SUPPL-70","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125288s070lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/125288Orig1s070ltr.pdf\"}]","notes":">"},{"actionDate":"09\/30\/2014","submission":"SUPPL-62","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/125288s062lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/125288Orig1s062ltr.pdf\"}]","notes":">"},{"actionDate":"04\/15\/2014","submission":"SUPPL-59","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/125288s059lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/125288Orig1s059ltr.pdf\"}]","notes":">"},{"actionDate":"04\/08\/2013","submission":"SUPPL-30","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/125288s030lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/125288Orig1s030ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2018-04-13
        )

)
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.