Documents
Application Sponsors
| BLA 125118 | BRISTOL MYERS SQUIBB | |
Marketing Status
Application Products
| 001 | INJECTABLE; IV (INFUSION) | 250MG | 0 | ORENCIA | ABATACEPT |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2005-12-23 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 16 | AP | 2007-03-13 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 2006-12-12 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 45 | AP | 2008-04-07 | STANDARD |
| LABELING; Labeling | SUPPL | 59 | AP | 2008-03-21 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 86 | AP | 2009-08-25 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 107 | AP | 2011-06-23 | |
| EFFICACY; Efficacy | SUPPL | 122 | AP | 2011-07-29 | STANDARD |
| LABELING; Labeling | SUPPL | 131 | AP | 2011-08-18 | STANDARD |
| LABELING; Labeling | SUPPL | 138 | AP | 2012-02-17 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 171 | AP | 2013-12-20 | STANDARD |
| LABELING; Labeling | SUPPL | 179 | AP | 2014-12-30 | STANDARD |
| LABELING; Labeling | SUPPL | 194 | AP | 2020-06-17 | STANDARD |
| LABELING; Labeling | SUPPL | 199 | AP | 2020-06-17 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 200 | AP | 2016-06-07 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 209 | AP | 2017-06-30 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 211 | AP | 2017-03-30 | PRIORITY |
| LABELING; Labeling | SUPPL | 224 | AP | 2019-03-21 | STANDARD |
| LABELING; Labeling | SUPPL | 225 | AP | 2020-06-17 | STANDARD |
| LABELING; Labeling | SUPPL | 235 | AP | 2022-04-13 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 240 | AP | 2021-12-15 | PRIORITY |
Submissions Property Types
| ORIG | 1 | Null | 2 |
| SUPPL | 107 | Null | 0 |
| SUPPL | 179 | Null | 15 |
| SUPPL | 194 | Null | 15 |
| SUPPL | 199 | Null | 15 |
| SUPPL | 200 | Null | 15 |
| SUPPL | 209 | Null | 15 |
| SUPPL | 211 | Null | 7 |
| SUPPL | 224 | Null | 15 |
| SUPPL | 225 | Null | 6 |
| SUPPL | 235 | Null | 7 |
| SUPPL | 240 | Null | 6 |
CDER Filings
BRISTOL MYERS SQUIBB
cder:Array
(
[0] => Array
(
[ApplNo] => 125118
[companyName] => BRISTOL MYERS SQUIBB
[docInserts] => ["",""]
[products] => [{"drugName":"ORENCIA","activeIngredients":"ABATACEPT","strength":"250MG","dosageForm":"INJECTABLE; IV (INFUSION)","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"06\/17\/2020","submission":"SUPPL-225","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125118s194,s199,s225lbl.pdf\"}]","notes":""},{"actionDate":"06\/17\/2020","submission":"SUPPL-199","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125118s194,s199,s225lbl.pdf\"}]","notes":""},{"actionDate":"06\/17\/2020","submission":"SUPPL-194","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125118s194,s199,s225lbl.pdf\"}]","notes":""},{"actionDate":"03\/21\/2019","submission":"SUPPL-224","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125118s224lbl.pdf\"}]","notes":""},{"actionDate":"06\/30\/2017","submission":"SUPPL-209","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125118s209lbl.pdf\"}]","notes":""},{"actionDate":"03\/30\/2017","submission":"SUPPL-211","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125118s211lbl.pdf\"}]","notes":""},{"actionDate":"12\/30\/2014","submission":"SUPPL-179","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/125118s179lbl.pdf\"}]","notes":""},{"actionDate":"12\/20\/2013","submission":"SUPPL-171","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/125118s171lbl.pdf\"}]","notes":""},{"actionDate":"02\/17\/2012","submission":"SUPPL-138","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/125118s0138lbl.pdf\"}]","notes":""},{"actionDate":"08\/25\/2009","submission":"SUPPL-86","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/125118s0086lbl.pdf\"}]","notes":""},{"actionDate":"03\/13\/2007","submission":"SUPPL-16","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/125118s0016lbl.pdf\"}]","notes":""},{"actionDate":"12\/23\/2005","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/125118lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"12\/23\/2005","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/125118lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2005\\\/125118rev2.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2005\\\/125118_s0000_OrenciaTOC.cfm\"}]","notes":">"}]
[supplements] => [{"actionDate":"06\/17\/2020","submission":"SUPPL-225","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125118s194,s199,s225lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"03\/21\/2019","submission":"SUPPL-224","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125118s224lbl.pdf\"}]","notes":">"},{"actionDate":"03\/30\/2017","submission":"SUPPL-211","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125118s211lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/125118Orig1s211ltr.pdf\"}]","notes":">"},{"actionDate":"06\/30\/2017","submission":"SUPPL-209","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125118s209lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/125118Orig1s209ltr.pdf\"}]","notes":">"},{"actionDate":"06\/07\/2016","submission":"SUPPL-200","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/17\/2020","submission":"SUPPL-199","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125118s194,s199,s225lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"06\/17\/2020","submission":"SUPPL-194","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125118s194,s199,s225lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"12\/30\/2014","submission":"SUPPL-179","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/125118s179lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/125118Orig1s179ltr.pdf\"}]","notes":">"},{"actionDate":"12\/20\/2013","submission":"SUPPL-171","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/125118s171lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/125118Orig1s171ltr.pdf\"}]","notes":">"},{"actionDate":"02\/17\/2012","submission":"SUPPL-138","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/125118s0138lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/125118s0138ltr.pdf\"}]","notes":">"},{"actionDate":"08\/18\/2011","submission":"SUPPL-131","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/29\/2011","submission":"SUPPL-122","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2011\\\/125118s0122ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2011\\\/125118Orig1s122.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"06\/23\/2011","submission":"SUPPL-107","supplementCategories":"Supplement","inserts":"[{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/bla\\\/2011\\\/125118Orig1s107.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"08\/25\/2009","submission":"SUPPL-86","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/125118s0086lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2009\\\/125118s0086ltr.pdf\"}]","notes":">"},{"actionDate":"03\/21\/2008","submission":"SUPPL-59","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/07\/2008","submission":"SUPPL-45","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2008\\\/125118s045ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"12\/12\/2006","submission":"SUPPL-18","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/13\/2007","submission":"SUPPL-16","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/125118s0016lbl.pdf\"}]","notes":">"}]
[actionDate] => 2020-06-17
)
)