Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 125118
Company: BRISTOL MYERS SQUIBB
Company: BRISTOL MYERS SQUIBB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ORENCIA | ABATACEPT | 250MG | INJECTABLE; IV (INFUSION) | Prescription | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/23/2005 | ORIG-1 | Approval | N/A; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/125118lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/125118rev2.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/125118_s0000_OrenciaTOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/30/2023 | SUPPL-250 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125118s250lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/125118Orig1s250ltr.pdf | |
| 01/19/2024 | SUPPL-249 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125118s249lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/125118Orig1s249ltr.pdf | |
| 12/15/2021 | SUPPL-240 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125118s240lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125118Orig1s240ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/125118Orig1s240.pdf | |
| 04/13/2022 | SUPPL-235 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125118Orig1s235ltr.pdf |
| 06/17/2020 | SUPPL-225 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125118s194,s199,s225lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125118Origs194, s199, s225ltr.pdf | |
| 03/21/2019 | SUPPL-224 | Supplement |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125118s224lbl.pdf | |
| 03/30/2017 | SUPPL-211 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125118s211lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125118Orig1s211ltr.pdf | |
| 06/30/2017 | SUPPL-209 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125118s209lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125118Orig1s209ltr.pdf | |
| 06/07/2016 | SUPPL-200 | Supplement |
Label is not available on this site. |
||
| 06/17/2020 | SUPPL-199 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125118s194,s199,s225lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125118Origs194, s199, s225ltr.pdf | |
| 06/17/2020 | SUPPL-194 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125118s194,s199,s225lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125118Origs194, s199, s225ltr.pdf | |
| 12/30/2014 | SUPPL-179 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125118s179lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125118Orig1s179ltr.pdf | |
| 12/20/2013 | SUPPL-171 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125118s171lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125118Orig1s171ltr.pdf | |
| 02/17/2012 | SUPPL-138 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125118s0138lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125118s0138ltr.pdf | |
| 08/18/2011 | SUPPL-131 | Supplement |
Label is not available on this site. |
||
| 07/29/2011 | SUPPL-122 | Supplement |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125118s0122ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/125118Orig1s122.pdf |
| 06/23/2011 | SUPPL-107 | Supplement |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/bla/2011/125118Orig1s107.pdf |
| 08/25/2009 | SUPPL-86 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125118s0086lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125118s0086ltr.pdf | |
| 03/21/2008 | SUPPL-59 | Supplement |
Label is not available on this site. |
||
| 04/07/2008 | SUPPL-45 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125118s045ltr.pdf |
| 12/12/2006 | SUPPL-18 | Supplement |
Label is not available on this site. |
||
| 03/13/2007 | SUPPL-16 | Supplement |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/125118s0016lbl.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/19/2024 | SUPPL-249 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125118s249lbl.pdf | |
| 10/30/2023 | SUPPL-250 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125118s250lbl.pdf | |
| 12/15/2021 | SUPPL-240 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125118s240lbl.pdf | |
| 06/17/2020 | SUPPL-225 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125118s194,s199,s225lbl.pdf | |
| 06/17/2020 | SUPPL-199 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125118s194,s199,s225lbl.pdf | |
| 06/17/2020 | SUPPL-194 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125118s194,s199,s225lbl.pdf | |
| 03/21/2019 | SUPPL-224 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125118s224lbl.pdf | |
| 06/30/2017 | SUPPL-209 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125118s209lbl.pdf | |
| 03/30/2017 | SUPPL-211 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125118s211lbl.pdf | |
| 12/30/2014 | SUPPL-179 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125118s179lbl.pdf | |
| 12/20/2013 | SUPPL-171 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125118s171lbl.pdf | |
| 02/17/2012 | SUPPL-138 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125118s0138lbl.pdf | |
| 08/25/2009 | SUPPL-86 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125118s0086lbl.pdf | |
| 03/13/2007 | SUPPL-16 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/125118s0016lbl.pdf | |
| 12/23/2005 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/125118lbl.pdf |