Drugs@FDA: FDA-Approved Drugs
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 |
|---|---|---|---|---|---|
| 03/06/2024 | SUPPL-128 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125554s128lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/125554Orig1s128ltr.pdf | |
| 03/06/2024 | SUPPL-125 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125554s125lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/125554Orig1s125ltr.pdf | |
| 01/26/2024 | SUPPL-122 | Supplement |
Label is not available on this site. |
||
| 10/13/2023 | SUPPL-121 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125554Orig1s121lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/125554Orig1s121ltr.pdf | |
| 02/15/2023 | SUPPL-119 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125554s119lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/125554Orig1s119ltr.pdf | |
| 02/15/2023 | SUPPL-118 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125554s118lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/125554Orig1s118ltr.pdf | |
| 02/15/2023 | SUPPL-117 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125554s117lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/125554Orig1s117ltr.pdf | |
| 07/14/2022 | SUPPL-114 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125554s114lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125554Orig1s114ltr.pdf | |
| 03/04/2022 | SUPPL-112 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125554s112lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125554Orig1s112ltr.pdf | |
| 02/25/2022 | SUPPL-109 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125554s109lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125554Orig1s109ltr.pdf | |
| 05/11/2022 | SUPPL-108 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125554s108lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125554Orig1s108.ltr.pdf | |
| 07/23/2021 | SUPPL-107 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125554s107lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125554Orig1s107ltr.pdf | |
| 05/27/2022 | SUPPL-106 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125554s106lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125554Orig1s106ltr.pdf | |
| 05/27/2022 | SUPPL-105 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125554s105lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125554Orig1s105ltr.pdf | |
| 07/15/2021 | SUPPL-99 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125554s099lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125554Orig1s099ltr.pdf | |
| 03/30/2021 | SUPPL-98 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125554s092lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125554Orig1s098ltr.pdf | |
| 08/19/2021 | SUPPL-97 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125554s097lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125554Orig1s097ltr.pdf | |
| 12/29/2020 | SUPPL-95 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125554s095lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125554Orig1s095ltr.pdf | |
| 05/20/2021 | SUPPL-92 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125554s092lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125554Orig1s092ltr.pdf | |
| 04/16/2021 | SUPPL-91 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125554s091lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125554Orig1s091ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/125554Orig1s091.pdf | |
| 01/22/2021 | SUPPL-90 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125554s090lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125554Orig1s090ltr.pdf | |
| 10/02/2020 | SUPPL-89 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125554s089lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125554Orig1s089ltr.pdf | |
| 09/25/2020 | SUPPL-86 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125554s086lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125554Orig1s086ltr.pdf | |
| 09/18/2020 | SUPPL-85 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125554s084s085lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125554Orig1s084, 125554Orig1s085ltr.pdf | |
| 09/18/2020 | SUPPL-84 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125554Orig1s084, 125554Orig1s085ltr.pdf |
| 06/23/2020 | SUPPL-83 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125554s083lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125554Orig1s083ltr.pdf | |
| 05/26/2020 | SUPPL-82 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125554s082lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125554Orig1s082ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/125377Orig1s110_125554Orig1s082.pdf | |
| 06/10/2020 | SUPPL-81 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125554s081lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125554Orig1s081ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/125554Orig1s081.pdf | |
| 05/15/2020 | SUPPL-80 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125554s080lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125554Orig1s080ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/125554Orig1s080.pdf | |
| 03/10/2020 | SUPPL-78 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125554s078lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125554Orig1s078ltr.pdf | |
| 09/18/2019 | SUPPL-75 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125554s075lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125554Orig1s075ltr.pdf | |
| 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 | |
| 11/10/2020 | SUPPL-71 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125554s071lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125554Orig1s071ltr.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) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125554s048s049s050s051s052s061s062s064s065s066lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125554Orig1s048s049s050s051s052s061s062s064s065s066ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/125554Orig1s066.pdf | |
| 03/05/2018 | SUPPL-65 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125554s048s049s050s051s052s061s062s064s065s066lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125554Orig1s048s049s050s051s052s061s062s064s065s066ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/125554Orig1s065.pdf | |
| 03/05/2018 | SUPPL-64 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125554s048s049s050s051s052s061s062s064s065s066lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125554Orig1s048s049s050s051s052s061s062s064s065s066ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/125554Orig1s064.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) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125554s048s049s050s051s052s061s062s064s065s066lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125554Orig1s048s049s050s051s052s061s062s064s065s066ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/125554Orig1s062.pdf | |
| 03/05/2018 | SUPPL-61 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125554s061lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125554Orig1s048s049s050s051s052s061s062s064s065s066ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/125554Orig1s061.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) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125554s048s049s050s051s052s061s062s064s065s066lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125554Orig1s048s049s050s051s052s061s062s064s065s066ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/125554Orig1s052.pdf | |
| 03/05/2018 | SUPPL-51 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125554s048s049s050s051s052s061s062s064s065s066lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125554Orig1s048s049s050s051s052s061s062s064s065s066ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/125554Orig1s051.pdf | |
| 03/05/2018 | SUPPL-50 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125554s048s049s050s051s052s061s062s064s065s066lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125554Orig1s048s049s050s051s052s061s062s064s065s066ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/125554Orig1s050.pdf | |
| 03/05/2018 | SUPPL-49 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125554s048s049s050s051s052s061s062s064s065s066lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125554Orig1s048s049s050s051s052s061s062s064s065s066ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/125554Orig1s049.pdf | |
| 03/05/2018 | SUPPL-48 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125554s048s049s050s051s052s061s062s064s065s066lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125554Orig1s048s049s050s051s052s061s062s064s065s066ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/125554Orig1s048.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) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125554s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125554Orig1s041ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/125554Orig1s041.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) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125554s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125554Orig1s034ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/125554Orig1s034.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) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125554s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125554Orig1s022ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/125554Orig1s022.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 | |
| 04/14/2015 | SUPPL-4 | Supplement |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125554Orig1s004.pdf |
| 04/14/2015 | SUPPL-3 | Supplement |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125554Orig1s003.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 |
|---|---|---|---|---|---|
| 03/06/2024 | SUPPL-128 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125554s128lbl.pdf | |
| 03/06/2024 | SUPPL-125 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125554s125lbl.pdf | |
| 10/13/2023 | SUPPL-121 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125554Orig1s121lbl.pdf | |
| 02/15/2023 | SUPPL-119 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125554s119lbl.pdf | |
| 02/15/2023 | SUPPL-118 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125554s118lbl.pdf | |
| 02/15/2023 | SUPPL-117 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125554s117lbl.pdf | |
| 07/14/2022 | SUPPL-114 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125554s114lbl.pdf | |
| 05/27/2022 | SUPPL-106 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125554s106lbl.pdf | |
| 05/27/2022 | SUPPL-105 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125554s105lbl.pdf | |
| 05/11/2022 | SUPPL-108 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125554s108lbl.pdf | |
| 03/04/2022 | SUPPL-112 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125554s112lbl.pdf | |
| 02/25/2022 | SUPPL-109 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125554s109lbl.pdf | |
| 08/19/2021 | SUPPL-97 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125554s097lbledt.pdf | |
| 07/23/2021 | SUPPL-107 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125554s107lbl.pdf | |
| 07/15/2021 | SUPPL-99 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125554s099lbl.pdf | |
| 07/15/2021 | SUPPL-99 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125554s099lbl.pdf | |
| 05/20/2021 | SUPPL-92 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125554s092lbl.pdf | |
| 04/16/2021 | SUPPL-91 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125554s091lbl.pdf | |
| 03/30/2021 | SUPPL-98 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125554s092lbl.pdf | |
| 01/22/2021 | SUPPL-90 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125554s090lbl.pdf | |
| 12/29/2020 | SUPPL-95 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125554s095lbl.pdf | |
| 11/10/2020 | SUPPL-71 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125554s071lbl.pdf | |
| 11/10/2020 | SUPPL-71 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125554s071lbl.pdf | |
| 10/02/2020 | SUPPL-89 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125554s089lbl.pdf | |
| 09/25/2020 | SUPPL-86 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125554s086lbl.pdf | |
| 09/18/2020 | SUPPL-85 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125554s084s085lbl.pdf | |
| 06/23/2020 | SUPPL-83 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125554s083lbl.pdf | |
| 06/10/2020 | SUPPL-81 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125554s081lbl.pdf | |
| 05/26/2020 | SUPPL-82 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125554s082lbl.pdf | |
| 05/15/2020 | SUPPL-80 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125554s080lbl.pdf | |
| 03/10/2020 | SUPPL-78 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125554s078lbl.pdf | |
| 09/18/2019 | SUPPL-75 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125554s075lbl.pdf | |
| 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 |