Drugs@FDA: FDA Approved Drug Products
Biologic License Application (BLA): 125554
Company: BRISTOL MYERS SQUIBB
Company: BRISTOL MYERS SQUIBB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| OPDIVO | NIVOLUMAB | 40MG/4ML | INJECTABLE;INJECTION | Prescription | None | TBD | 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 |
|---|---|---|---|---|---|---|---|
| 12/22/2014 | ORIG-1 | Approval | N/A; Orphan |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125554lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125554Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125554Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125554Orig1s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/02/2019 | SUPPL-73 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125554s073lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125554Orig1s073ltr.pdf | |
| 02/01/2019 | SUPPL-72 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125554s072lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125554Orig1s072ltr.pdf | |
| 04/18/2019 | SUPPL-70 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125554s070lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125554Orig1s070ltr.pdf | |
| 11/15/2018 | SUPPL-69 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125554s069lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125554Orig1s069ltr.pdf | |
| 08/16/2018 | SUPPL-67 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125554s067lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125554Orig1s067Ltr.pdf | |
| 03/05/2018 | SUPPL-66 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125554s048s049s050s051s052s061s062s064s065s066lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125554Orig1s048s049s050s051s052s061s062s064s065s066ltr.pdf | |
| 03/05/2018 | SUPPL-65 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125554s048s049s050s051s052s061s062s064s065s066lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125554Orig1s048s049s050s051s052s061s062s064s065s066ltr.pdf | |
| 03/05/2018 | SUPPL-64 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125554s048s049s050s051s052s061s062s064s065s066lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125554Orig1s048s049s050s051s052s061s062s064s065s066ltr.pdf | |
| 07/10/2018 | SUPPL-63 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125554s063lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125554Orig1s063ltr.pdf | |
| 03/05/2018 | SUPPL-62 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125554s048s049s050s051s052s061s062s064s065s066lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125554Orig1s048s049s050s051s052s061s062s064s065s066ltr.pdf | |
| 03/05/2018 | SUPPL-61 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125554s061lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125554Orig1s048s049s050s051s052s061s062s064s065s066ltr.pdf | |
| 04/16/2018 | SUPPL-58 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125554s058lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125554Orig1s058ltr.pdf | |
| 02/13/2018 | SUPPL-56 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125554s056lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125554Orig1s056ltr.pdf | |
| 12/20/2017 | SUPPL-55 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125554s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125554Orig1s055ltr.pdf | |
| 03/05/2018 | SUPPL-52 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125554s048s049s050s051s052s061s062s064s065s066lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125554Orig1s048s049s050s051s052s061s062s064s065s066ltr.pdf | |
| 03/05/2018 | SUPPL-51 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125554s048s049s050s051s052s061s062s064s065s066lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125554Orig1s048s049s050s051s052s061s062s064s065s066ltr.pdf | |
| 03/05/2018 | SUPPL-50 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125554s048s049s050s051s052s061s062s064s065s066lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125554Orig1s048s049s050s051s052s061s062s064s065s066ltr.pdf | |
| 03/05/2018 | SUPPL-49 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125554s048s049s050s051s052s061s062s064s065s066lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125554Orig1s048s049s050s051s052s061s062s064s065s066ltr.pdf | |
| 03/05/2018 | SUPPL-48 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125554s048s049s050s051s052s061s062s064s065s066lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125554Orig1s048s049s050s051s052s061s062s064s065s066ltr.pdf | |
| 02/15/2018 | SUPPL-45 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125554s044s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125554Orig1s044s045ltr.pdf | |
| 02/15/2018 | SUPPL-44 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125554s044s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125554Orig1s044s045ltr.pdf | |
| 03/07/2019 | SUPPL-42 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125554s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125554Orig1s042ltr.pdf | |
| 09/22/2017 | SUPPL-41 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125554s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125554Orig1s041ltr.pdf | |
| 09/06/2017 | SUPPL-40 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125554s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125554Orig1s040ltr.pdf | |
| 01/09/2018 | SUPPL-39 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125554Orig1s035s036s037s038s039ltr.pdf |
| 01/09/2018 | SUPPL-38 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125554Orig1s035s036s037s038s039ltr.pdf |
| 01/09/2018 | SUPPL-37 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125554Orig1s035s036s037s038s039ltr.pdf |
| 01/09/2018 | SUPPL-36 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125554Orig1s035s036s037s038s039ltr.pdf |
| 01/09/2018 | SUPPL-35 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125554s035s036s037s038s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125554Orig1s035s036s037s038s039ltr.pdf | |
| 07/31/2017 | SUPPL-34 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125554s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125554Orig1s034ltr.pdf | |
| 04/25/2017 | SUPPL-31 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125554s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125554Orig1s031ltr.pdf | |
| 02/02/2017 | SUPPL-24 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125554s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125554Orig1s024ltr.pdf | |
| 11/10/2016 | SUPPL-22 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125554s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125554Orig1s022ltr.pdf | |
| 05/17/2016 | SUPPL-19 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125554s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125554Orig1s019ltr.pdf | |
| 09/13/2016 | SUPPL-18 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125554s017s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125554Orig1s017,s018ltr.pdf | |
| 09/13/2016 | SUPPL-17 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125554s017s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125554Orig1s017,s018ltr.pdf | |
| 10/04/2016 | SUPPL-16 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125554s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125554Orig1s016ltr.pdf | |
| 11/23/2015 | SUPPL-12 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125554s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125554Orig1s012ltr.pdf | |
| 01/23/2016 | SUPPL-7 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125554Orig1s007ltr.pdf |
| 10/09/2015 | SUPPL-5 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125554s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125554Orig1s005ltr.pdf | |
| 09/30/2015 | SUPPL-2 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125554s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125554Orig1s002ltr.pdf | |
| 11/23/2015 | SUPPL-1 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125554s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125554Orig1s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/02/2019 | SUPPL-73 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125554s073lbl.pdf | |
| 04/18/2019 | SUPPL-70 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125554s070lbl.pdf | |
| 03/07/2019 | SUPPL-42 | Efficacy-Accelerated Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125554s042lbl.pdf | |
| 02/01/2019 | SUPPL-72 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125554s072lbl.pdf | |
| 11/15/2018 | SUPPL-69 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125554s069lbl.pdf | |
| 08/16/2018 | SUPPL-67 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125554s067lbl.pdf | |
| 07/10/2018 | SUPPL-63 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125554s063lbl.pdf | |
| 04/16/2018 | SUPPL-58 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125554s058lbl.pdf | |
| 03/05/2018 | SUPPL-66 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125554s048s049s050s051s052s061s062s064s065s066lbl.pdf | |
| 03/05/2018 | SUPPL-65 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125554s048s049s050s051s052s061s062s064s065s066lbl.pdf | |
| 03/05/2018 | SUPPL-64 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125554s048s049s050s051s052s061s062s064s065s066lbl.pdf | |
| 03/05/2018 | SUPPL-62 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125554s048s049s050s051s052s061s062s064s065s066lbl.pdf | |
| 03/05/2018 | SUPPL-61 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125554s061lbl.pdf | |
| 03/05/2018 | SUPPL-52 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125554s048s049s050s051s052s061s062s064s065s066lbl.pdf | |
| 03/05/2018 | SUPPL-51 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125554s048s049s050s051s052s061s062s064s065s066lbl.pdf | |
| 03/05/2018 | SUPPL-50 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125554s048s049s050s051s052s061s062s064s065s066lbl.pdf | |
| 03/05/2018 | SUPPL-49 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125554s048s049s050s051s052s061s062s064s065s066lbl.pdf | |
| 03/05/2018 | SUPPL-48 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125554s048s049s050s051s052s061s062s064s065s066lbl.pdf | |
| 02/15/2018 | SUPPL-45 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125554s044s045lbl.pdf | |
| 02/15/2018 | SUPPL-44 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125554s044s045lbl.pdf | |
| 02/13/2018 | SUPPL-56 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125554s056lbl.pdf | |
| 01/09/2018 | SUPPL-35 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125554s035s036s037s038s039lbl.pdf | |
| 12/20/2017 | SUPPL-55 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125554s055lbl.pdf | |
| 09/22/2017 | SUPPL-41 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125554s041lbl.pdf | |
| 09/06/2017 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125554s040lbl.pdf | |
| 07/31/2017 | SUPPL-34 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125554s034lbl.pdf | |
| 04/25/2017 | SUPPL-31 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125554s031lbl.pdf | |
| 02/02/2017 | SUPPL-24 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125554s024lbl.pdf | |
| 11/10/2016 | SUPPL-22 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125554s022lbl.pdf | |
| 10/04/2016 | SUPPL-16 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125554s016lbl.pdf | |
| 09/13/2016 | SUPPL-18 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125554s017s018lbl.pdf | |
| 09/13/2016 | SUPPL-17 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125554s017s018lbl.pdf | |
| 05/17/2016 | SUPPL-19 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125554s019lbl.pdf | |
| 11/23/2015 | SUPPL-12 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125554s012lbl.pdf | |
| 11/23/2015 | SUPPL-1 | Efficacy-Accelerated Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125554s001lbl.pdf | |
| 10/09/2015 | SUPPL-5 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125554s005lbl.pdf | |
| 09/30/2015 | SUPPL-2 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125554s002lbl.pdf | |
| 12/22/2014 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125554lbl.pdf |
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