Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 125377
Company: BRISTOL MYERS SQUIBB
Company: BRISTOL MYERS SQUIBB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| YERVOY | IPILIMUMAB | 3MG | INJECTABLE; INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 03/25/2011 | ORIG-1 | Approval | N/A; Orphan |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125377s0000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125377s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/125377Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/125377Orig1s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/23/2022 | SUPPL-130 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125377s130lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125377Orig1s130ltr.pdf | |
| 02/15/2023 | SUPPL-129 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125377s129lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/125377Orig1s129ltr.pdf | |
| 02/25/2022 | SUPPL-127 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125377s127lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125377Orig1s127ltr.pdf | |
| 02/25/2022 | SUPPL-126 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125377s126lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125377Orig1s126ltr.pdf | |
| 05/11/2022 | SUPPL-124 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125377s124lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125377Orig1s124ltr.pdf | |
| 05/27/2022 | SUPPL-122 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125377s122lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125377Orig1s122ltr.pdf | |
| 05/25/2021 | SUPPL-121 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125377s121lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125377Orig1s121ltr.pdf | |
| 11/13/2020 | SUPPL-119 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125377s119lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125377Orig1s119ltr.pdf | |
| 10/02/2020 | SUPPL-115 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125377s115lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125377Orig1s115ltr.pdf | |
| 09/18/2020 | SUPPL-112 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125377s112lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125377Orig1s112ltr.pdf | |
| 08/13/2020 | SUPPL-111 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125377s111lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125377Orig1s111ltr.pdf | |
| 05/26/2020 | SUPPL-110 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125377s110lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125377Orig1s110ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/125377Orig1s110_125554Orig1s082.pdf | |
| 05/15/2020 | SUPPL-109 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125377s109lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125377Orig1s109ltr.pdf | |
| 03/10/2020 | SUPPL-108 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125377s108lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125377Orig1s108ltr.pdf | |
| 06/29/2020 | SUPPL-106 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125377s106lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125377Orig1s106ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/125377Orig1s106.pdf | |
| 09/20/2019 | SUPPL-104 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125377s104lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125377Orig1s104ltr.pdf | |
| 05/08/2019 | SUPPL-102 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125377s102lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125377Orig1s102ltr.pdf | |
| 07/10/2018 | SUPPL-96 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125377s096lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125377Orig1s096ltr.pdf | |
| 04/16/2018 | SUPPL-94 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125377s094lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125377Orig1s094ltr.pdf | |
| 02/08/2018 | SUPPL-93 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125377s093lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125377Orig1s093ltr.pdf | |
| 12/13/2017 | SUPPL-91 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125377s091lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125377Orig1s091ltr.pdf | |
| 07/21/2017 | SUPPL-87 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125377s087lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125377Orig1s087ltr.pdf | |
| 10/20/2017 | SUPPL-86 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125377s086lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125377Orig1s086ltr.pdf | |
| 03/03/2017 | SUPPL-84 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125377Orig1s084ltr.pdf |
| 08/17/2015 | SUPPL-74 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125377s074lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125377Orig1s074ltr.pdf | |
| 10/28/2015 | SUPPL-73 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125377s073lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125377Orig1s073ltr.pdf | |
| 03/19/2015 | SUPPL-72 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125377s072lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125377Orig1s072ltr.pdf | |
| 03/16/2015 | SUPPL-71 | Supplement |
Label is not available on this site. |
||
| 12/05/2013 | SUPPL-55 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125377s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125377Orig1s055ltr.pdf | |
| 05/22/2013 | SUPPL-44 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125377s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125377Orig1s044ltr.pdf | |
| 10/26/2012 | SUPPL-33 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125377s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125377Orig1s033ltr.pdf | |
| 02/16/2012 | SUPPL-16 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125377s016ltr.pdf |
| 07/28/2011 | SUPPL-8 | Supplement |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/15/2023 | SUPPL-129 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125377s129lbl.pdf | |
| 11/23/2022 | SUPPL-130 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125377s130lbl.pdf | |
| 11/23/2022 | SUPPL-130 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125377s130lbl.pdf | |
| 05/27/2022 | SUPPL-122 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125377s122lbl.pdf | |
| 05/11/2022 | SUPPL-124 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125377s124lbl.pdf | |
| 02/25/2022 | SUPPL-127 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125377s127lbl.pdf | |
| 02/25/2022 | SUPPL-126 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125377s126lbl.pdf | |
| 05/25/2021 | SUPPL-121 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125377s121lbl.pdf | |
| 11/13/2020 | SUPPL-119 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125377s119lbl.pdf | |
| 10/02/2020 | SUPPL-115 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125377s115lbl.pdf | |
| 09/18/2020 | SUPPL-112 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125377s112lbl.pdf | |
| 08/13/2020 | SUPPL-111 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125377s111lbl.pdf | |
| 06/29/2020 | SUPPL-106 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125377s106lbl.pdf | |
| 05/26/2020 | SUPPL-110 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125377s110lbl.pdf | |
| 05/15/2020 | SUPPL-109 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125377s109lbl.pdf | |
| 03/10/2020 | SUPPL-108 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125377s108lbl.pdf | |
| 09/20/2019 | SUPPL-104 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125377s104lbl.pdf | |
| 05/08/2019 | SUPPL-102 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125377s102lbl.pdf | |
| 07/10/2018 | SUPPL-96 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125377s096lbl.pdf | |
| 04/16/2018 | SUPPL-94 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125377s094lbl.pdf | |
| 02/08/2018 | SUPPL-93 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125377s093lbl.pdf | |
| 12/13/2017 | SUPPL-91 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125377s091lbl.pdf | |
| 10/20/2017 | SUPPL-86 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125377s086lbl.pdf | |
| 07/21/2017 | SUPPL-87 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125377s087lbl.pdf | |
| 10/28/2015 | SUPPL-73 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125377s073lbl.pdf | |
| 08/17/2015 | SUPPL-74 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125377s074lbl.pdf | |
| 08/17/2015 | SUPPL-74 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125377s074lbl.pdf | |
| 03/19/2015 | SUPPL-72 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125377s072lbl.pdf | |
| 12/05/2013 | SUPPL-55 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125377s055lbl.pdf | |
| 05/22/2013 | SUPPL-44 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125377s044lbl.pdf | |
| 10/26/2012 | SUPPL-33 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125377s033lbl.pdf | |
| 03/25/2011 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125377s0000lbl.pdf |