Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 125514
Company: MERCK SHARP DOHME
Company: MERCK SHARP DOHME
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| KEYTRUDA | PEMBROLIZUMAB | 100MG/4ML (25MG/ML) | SOLUTION;INTRAVENOUS | 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 |
|---|---|---|---|---|---|---|---|
| 09/04/2014 | ORIG-1 | Approval | N/A; Orphan |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125514lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125514Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125514Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125514Orig1s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/05/2022 | SUPPL-133 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125514s133lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125514Orig1s133ltr.pdf | |
| 06/21/2022 | SUPPL-131 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125514s131lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125514Orig1s131ltr.pdf | |
| 01/26/2023 | SUPPL-128 | Supplement |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125514s128lbl.pdf | |
| 12/16/2022 | SUPPL-127 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125514s127lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125514Orig1s127ltr.pdf | |
| 02/04/2022 | SUPPL-125 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125514s125lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125514Orig1s125ltr.pdf | |
| 05/20/2022 | SUPPL-123 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125514s123lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125514Orig1s123ltr.pdf | |
| 10/13/2021 | SUPPL-122 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125514s121s122lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125514Orig1s121_s122ltr.pdf | |
| 10/13/2021 | SUPPL-121 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125514s121s122lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125514Orig1s121_s122ltr.pdf | |
| 12/17/2021 | SUPPL-120 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125514s120lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125514Orig1s120ltr.pdf | |
| 08/31/2021 | SUPPL-118 | Supplement |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125514s117,s118lbl.pdf | |
| 08/31/2021 | SUPPL-117 | Supplement |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125514s117,s118lbl.pdf | |
| 07/26/2021 | SUPPL-114 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125514s089s114lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125514Orig1s089s114ltr_.pdf | |
| 11/17/2021 | SUPPL-113 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125514s113lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125514Orig1s113ltr.pdf | |
| 12/03/2021 | SUPPL-112 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125514s112lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125514Orig1s112ltr.pdf | |
| 03/21/2022 | SUPPL-110 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125514s110lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125514Orig1s110ltr.pdf | |
| 06/28/2021 | SUPPL-108 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125514s108lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125514Orig1s108ltr.pdf | |
| 03/30/2021 | SUPPL-106 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125514Orig1s106ltr.pdf |
| 07/21/2021 | SUPPL-105 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125514s105lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125514Orig1s105ltr.pdf | |
| 08/03/2021 | SUPPL-104 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125514s104lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125514Orig1s104ltr.pdf | |
| 08/10/2021 | SUPPL-102 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125514s102lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125514Orig1s102ltr.pdf | |
| 07/01/2021 | SUPPL-100 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125514s100lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125514Orig1s100ltr.pdf | |
| 02/10/2021 | SUPPL-98 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125514Orig1s098ltr.pdf |
| 05/05/2021 | SUPPL-97 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125514s097lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125514Orig1s097ltr.pdf | |
| 03/22/2021 | SUPPL-96 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125514s096lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125514Orig1s096ltr.pdf | |
| 02/04/2022 | SUPPL-95 | Supplement |
Label is not available on this site. |
||
| 03/16/2021 | SUPPL-93 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125514s091s093lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125514Orig1s091,s093ltr.pdf | |
| 06/24/2020 | SUPPL-92 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125514s092lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125514Orig1s092ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/125514Orig1s092.pdf | |
| 03/16/2021 | SUPPL-91 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125514s091s093lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125514Orig1s091,s093ltr.pdf | |
| 06/16/2020 | SUPPL-90 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125514s071s090lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125514Orig1s071,s090ltr.pdf | |
| 07/26/2021 | SUPPL-89 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125514s089s114lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125514Orig1s089s114ltr_.pdf | |
| 11/13/2020 | SUPPL-88 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125514s088lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125514Orig1s088ltr.pdf | |
| 10/14/2020 | SUPPL-85 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125514s085lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125514Orig1s085ltr.pdf | |
| 06/29/2020 | SUPPL-84 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125514s084lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125514Orig1s084ltr.pdf | |
| 04/28/2020 | SUPPL-83 | Supplement |
Label (PDF)
Letter (PDF) Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125514s059s064s076s083lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125514Orig1s059,s060,s061,s062,s063,s064,s069,s076,s077,s078,s079,s080,s081,s082,s083ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125514s59-64,69,76-83SumR.pdf | |
| 04/28/2020 | SUPPL-82 | Supplement |
Letter (PDF)
Summary Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125514Orig1s059,s060,s061,s062,s063,s064,s069,s076,s077,s078,s079,s080,s081,s082,s083ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125514s59-64,69,76-83SumR.pdf |
| 04/28/2020 | SUPPL-81 | Supplement |
Letter (PDF)
Summary Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125514Orig1s059,s060,s061,s062,s063,s064,s069,s076,s077,s078,s079,s080,s081,s082,s083ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125514s59-64,69,76-83SumR.pdf |
| 04/28/2020 | SUPPL-80 | Supplement |
Letter (PDF)
Summary Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125514Orig1s059,s060,s061,s062,s063,s064,s069,s076,s077,s078,s079,s080,s081,s082,s083ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125514s59-64,69,76-83SumR.pdf |
| 04/28/2020 | SUPPL-79 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125514s070lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125514Orig1s059,s060,s061,s062,s063,s064,s069,s076,s077,s078,s079,s080,s081,s082,s083ltr.pdf | |
| 04/28/2020 | SUPPL-78 | Supplement |
Letter (PDF)
Summary Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125514Orig1s059,s060,s061,s062,s063,s064,s069,s076,s077,s078,s079,s080,s081,s082,s083ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125514s59-64,69,76-83SumR.pdf |
| 04/28/2020 | SUPPL-77 | Supplement |
Letter (PDF)
Summary Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125514Orig1s059,s060,s061,s062,s063,s064,s069,s076,s077,s078,s079,s080,s081,s082,s083ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125514s59-64,69,76-83SumR.pdf |
| 04/28/2020 | SUPPL-76 | Supplement |
Letter (PDF)
Summary Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125514Orig1s059,s060,s061,s062,s063,s064,s069,s076,s077,s078,s079,s080,s081,s082,s083ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125514s59-64,69,76-83SumR.pdf |
| 06/16/2020 | SUPPL-71 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125514s071s090lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125514Orig1s071,s090ltr.pdf | |
| 10/02/2020 | SUPPL-70 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125514s070lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125514Orig1s070ltr.pdf | |
| 04/28/2020 | SUPPL-69 | Supplement |
Letter (PDF)
Summary Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125514Orig1s059,s060,s061,s062,s063,s064,s069,s076,s077,s078,s079,s080,s081,s082,s083ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125514s59-64,69,76-83SumR.pdf |
| 06/24/2020 | SUPPL-68 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125514s068lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125514Orig1s068ltr.pdf | |
| 01/09/2020 | SUPPL-67 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125514s067lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125514Orig1s067ltr.pdf | |
| 01/08/2020 | SUPPL-66 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125514s066lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125514Orig1s066ltr.pdf | |
| 09/17/2019 | SUPPL-65 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125514s065lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125514Orig1s065ltr.pdf | |
| 04/28/2020 | SUPPL-64 | Supplement |
Letter (PDF)
Summary Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125514Orig1s059,s060,s061,s062,s063,s064,s069,s076,s077,s078,s079,s080,s081,s082,s083ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125514s59-64,69,76-83SumR.pdf |
| 04/28/2020 | SUPPL-63 | Supplement |
Letter (PDF)
Summary Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125514Orig1s059,s060,s061,s062,s063,s064,s069,s076,s077,s078,s079,s080,s081,s082,s083ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125514s59-64,69,76-83SumR.pdf |
| 04/28/2020 | SUPPL-62 | Supplement |
Letter (PDF)
Summary Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125514Orig1s059,s060,s061,s062,s063,s064,s069,s076,s077,s078,s079,s080,s081,s082,s083ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125514s59-64,69,76-83SumR.pdf |
| 04/28/2020 | SUPPL-61 | Supplement |
Letter (PDF)
Summary Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125514Orig1s059,s060,s061,s062,s063,s064,s069,s076,s077,s078,s079,s080,s081,s082,s083ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125514s59-64,69,76-83SumR.pdf |
| 04/28/2020 | SUPPL-60 | Supplement |
Letter (PDF)
Summary Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125514Orig1s059,s060,s061,s062,s063,s064,s069,s076,s077,s078,s079,s080,s081,s082,s083ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125514s59-64,69,76-83SumR.pdf |
| 04/28/2020 | SUPPL-59 | Supplement |
Letter (PDF)
Summary Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125514Orig1s059,s060,s061,s062,s063,s064,s069,s076,s077,s078,s079,s080,s081,s082,s083ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125514s59-64,69,76-83SumR.pdf |
| 07/30/2019 | SUPPL-56 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125514s055s056lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125514Orig1s055,s056ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/125514Orig1s056.pdf | |
| 07/30/2019 | SUPPL-55 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125514s055s056lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125514Orig1s055,s056ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/125514Orig1s055.pdf | |
| 04/19/2019 | SUPPL-54 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125514Orig1s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125514Orig1s054ltr.pdf | |
| 06/17/2019 | SUPPL-53 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125514s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125514Orig1s053ltr.pdf | |
| 06/10/2019 | SUPPL-52 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125514s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125514Orig1s052ltr.pdf | |
| 11/10/2020 | SUPPL-48 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125514s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125514Orig1s048ltr.pdf | |
| 04/11/2019 | SUPPL-47 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125514s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125514Orig1s047ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/125514Orig1s047.pdf | |
| 08/16/2018 | SUPPL-46 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125514s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125514Orig1s046Ltr.pdf | |
| 12/19/2018 | SUPPL-45 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125514s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125514Orig1s045Ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/125514Orig1s045.pdf | |
| 06/19/2018 | SUPPL-43 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125514s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125514Orig1s043ltr.pdf | |
| 11/09/2018 | SUPPL-42 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125514s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125514Orig1s042ltr.pdf | |
| 10/30/2018 | SUPPL-41 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125514s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125514Orig1s041ltr.pdf | |
| 02/15/2019 | SUPPL-40 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125514s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125514Orig1s040ltr.pdf | |
| 12/28/2018 | SUPPL-37 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125514s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125514Orig1s037ltr.pdf | |
| 08/20/2018 | SUPPL-35 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125514s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125514Orig1s035ltr.pdf | |
| 06/12/2018 | SUPPL-34 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125514s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125514Orig1s034ltr.pdf | |
| 11/29/2017 | SUPPL-31 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125514s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125514Orig1s031ltr.pdf | |
| 06/13/2018 | SUPPL-30 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125514s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125514Orig1s030ltr.pdf | |
| 09/22/2017 | SUPPL-24 | Supplement |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125514s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125514Orig1s024ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/125514Orig1s024TOC.cfm | |
| 07/27/2017 | SUPPL-23 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125514s019s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125514Orig1s019s023ltr.pdf | |
| 07/27/2017 | SUPPL-19 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125514s019s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125514Orig1s019s023ltr.pdf | |
| 05/18/2017 | SUPPL-18 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125514s017s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125514Orig1s018ltr.pdf | |
| 05/18/2017 | SUPPL-17 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125514s017s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125514Orig1s017ltr.pdf | |
| 05/10/2017 | SUPPL-16 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125514s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125514Orig1s016ltr.pdf | |
| 03/14/2017 | SUPPL-15 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125514s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125514Orig1s015ltr.pdf | |
| 05/23/2017 | SUPPL-14 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125514s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125514Orig1s014ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/125514Orig1s014.pdf | |
| 05/17/2017 | SUPPL-13 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125514s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125514Orig1s013ltr.pdf | |
| 10/24/2016 | SUPPL-12 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125514s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125514Orig1s008,125514Orig1s012ltr.pdf | |
| 08/05/2016 | SUPPL-9 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125514s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125514Orig1s009ltr.pdf | |
| 10/24/2016 | SUPPL-8 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125514s008s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125514Orig1s008,125514Orig1s012ltr.pdf | |
| 12/18/2015 | SUPPL-6 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125514s004s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125514Orig1s004s006ltr.pdf | |
| 10/02/2015 | SUPPL-5 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125514s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125514Orig1s005ltr.pdf | |
| 12/18/2015 | SUPPL-4 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125514s004s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125514Orig1s004s006ltr.pdf | |
| 06/19/2015 | SUPPL-3 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125514s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125514Orig1s003ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/26/2023 | SUPPL-128 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125514s128lbl.pdf | |
| 12/16/2022 | SUPPL-127 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125514s127lbl.pdf | |
| 08/05/2022 | SUPPL-133 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125514s133lbl.pdf | |
| 08/05/2022 | SUPPL-133 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125514s133lbl.pdf | |
| 06/21/2022 | SUPPL-131 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125514s131lbl.pdf | |
| 05/20/2022 | SUPPL-123 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125514s123lbl.pdf | |
| 03/21/2022 | SUPPL-110 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125514s110lbl.pdf | |
| 02/04/2022 | SUPPL-125 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125514s125lbl.pdf | |
| 02/04/2022 | SUPPL-125 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125514s125lbl.pdf | |
| 12/17/2021 | SUPPL-120 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125514s120lbl.pdf | |
| 12/03/2021 | SUPPL-112 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125514s112lbl.pdf | |
| 11/17/2021 | SUPPL-113 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125514s113lbl.pdf | |
| 10/13/2021 | SUPPL-122 | Efficacy-Accelerated Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125514s121s122lbl.pdf | |
| 10/13/2021 | SUPPL-121 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125514s121s122lbl.pdf | |
| 08/31/2021 | SUPPL-118 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125514s117,s118lbl.pdf | |
| 08/31/2021 | SUPPL-117 | Efficacy-Accelerated Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125514s117,s118lbl.pdf | |
| 08/10/2021 | SUPPL-102 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125514s102lbl.pdf | |
| 08/03/2021 | SUPPL-104 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125514s104lbl.pdf | |
| 07/26/2021 | SUPPL-114 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125514s089s114lbl.pdf | |
| 07/26/2021 | SUPPL-89 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125514s089s114lbl.pdf | |
| 07/21/2021 | SUPPL-105 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125514s105lbl.pdf | |
| 07/01/2021 | SUPPL-100 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125514s100lbl.pdf | |
| 06/28/2021 | SUPPL-108 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125514s108lbl.pdf | |
| 06/28/2021 | SUPPL-108 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125514s108lbl.pdf | |
| 05/05/2021 | SUPPL-97 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125514s097lbl.pdf | |
| 03/22/2021 | SUPPL-96 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125514s096lbl.pdf | |
| 03/16/2021 | SUPPL-93 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125514s091s093lbl.pdf | |
| 03/16/2021 | SUPPL-91 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125514s091s093lbl.pdf | |
| 11/13/2020 | SUPPL-88 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125514s088lbl.pdf | |
| 11/10/2020 | SUPPL-48 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125514s048lbl.pdf | |
| 10/14/2020 | SUPPL-85 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125514s085lbl.pdf | |
| 10/02/2020 | SUPPL-70 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125514s070lbl.pdf | |
| 06/29/2020 | SUPPL-84 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125514s084lbl.pdf | |
| 06/24/2020 | SUPPL-92 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125514s092lbl.pdf | |
| 06/24/2020 | SUPPL-68 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125514s068lbl.pdf | |
| 06/16/2020 | SUPPL-90 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125514s071s090lbl.pdf | |
| 06/16/2020 | SUPPL-71 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125514s071s090lbl.pdf | |
| 04/28/2020 | SUPPL-83 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125514s059s064s076s083lbl.pdf | |
| 04/28/2020 | SUPPL-79 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125514s070lbl.pdf | |
| 01/09/2020 | SUPPL-67 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125514s067lbl.pdf | |
| 01/09/2020 | SUPPL-67 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125514s067lbl.pdf | |
| 01/08/2020 | SUPPL-66 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125514s066lbl.pdf | |
| 09/17/2019 | SUPPL-65 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125514s065lbl.pdf | |
| 07/30/2019 | SUPPL-56 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125514s055s056lbl.pdf | |
| 07/30/2019 | SUPPL-55 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125514s055s056lbl.pdf | |
| 06/17/2019 | SUPPL-53 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125514s053lbl.pdf | |
| 06/10/2019 | SUPPL-52 | Efficacy-Accelerated Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125514s052lbl.pdf | |
| 04/19/2019 | SUPPL-54 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125514Orig1s054lbl.pdf | |
| 04/11/2019 | SUPPL-47 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125514s047lbl.pdf | |
| 02/15/2019 | SUPPL-40 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125514s040lbl.pdf | |
| 12/28/2018 | SUPPL-37 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125514s037lbl.pdf | |
| 12/19/2018 | SUPPL-45 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125514s045lbl.pdf | |
| 11/09/2018 | SUPPL-42 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125514s042lbl.pdf | |
| 10/30/2018 | SUPPL-41 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125514s041lbl.pdf | |
| 08/20/2018 | SUPPL-35 | Efficacy-Accelerated Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125514s035lbl.pdf | |
| 08/16/2018 | SUPPL-46 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125514s046lbl.pdf | |
| 06/19/2018 | SUPPL-43 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125514s043lbl.pdf | |
| 06/13/2018 | SUPPL-30 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125514s030lbl.pdf | |
| 06/12/2018 | SUPPL-34 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125514s034lbl.pdf | |
| 11/29/2017 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125514s031lbl.pdf | |
| 09/22/2017 | SUPPL-24 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125514s024lbl.pdf | |
| 07/27/2017 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125514s019s023lbl.pdf | |
| 07/27/2017 | SUPPL-19 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125514s019s023lbl.pdf | |
| 07/27/2017 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125514s019s023lbl.pdf | |
| 05/23/2017 | SUPPL-14 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125514s014lbl.pdf | |
| 05/18/2017 | SUPPL-18 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125514s017s018lbl.pdf | |
| 05/18/2017 | SUPPL-17 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125514s017s018lbl.pdf | |
| 05/17/2017 | SUPPL-13 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125514s013lbl.pdf | |
| 05/10/2017 | SUPPL-16 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125514s016lbl.pdf | |
| 03/14/2017 | SUPPL-15 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125514s015lbl.pdf | |
| 10/24/2016 | SUPPL-12 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125514s012lbl.pdf | |
| 10/24/2016 | SUPPL-8 | Efficacy-Accelerated Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125514s008s012lbl.pdf | |
| 08/05/2016 | SUPPL-9 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125514s009lbl.pdf | |
| 12/18/2015 | SUPPL-6 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125514s004s006lbl.pdf | |
| 12/18/2015 | SUPPL-4 | Efficacy-Accelerated Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125514s004s006lbl.pdf | |
| 10/02/2015 | SUPPL-5 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125514s005lbl.pdf | |
| 06/19/2015 | SUPPL-3 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125514s003lbl.pdf | |
| 06/19/2015 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125514s003lbl.pdf | |
| 09/04/2014 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125514lbl.pdf |