Drugs@FDA: FDA Approved Drug Products
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 | 50MG | POWDER, FOR INJECTION SOLUTION, LYOPHILIZED POWDER | 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 |
|---|---|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|
| 08/16/2018 | 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 | |
| 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 | |
| 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) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125514s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125514Orig1s014ltr.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 |
|---|---|---|---|---|---|
| 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-Labeling Change With Clinical Data | 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-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 | |
| 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 |
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