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Drugs@FDA DRUGS@FDA: FDA-APPROVED DRUGS * Share * Tweet * Linkedin * Email * Print Home | Previous Page Biologic License Application (BLA): 125514 Company: MERCK SHARP DOHME * Email * Medication Guide * Summary Review PRODUCTS ON BLA 125514 CSVExcelPrint Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusTE CodeRLDRS KEYTRUDA PEMBROLIZUMAB 100MG/4ML (25MG/ML) SOLUTION;INTRAVENOUS Prescription None No No Showing 1 to 1 of 1 entries APPROVAL DATE(S) AND HISTORY, LETTERS, LABELS, REVIEWS FOR BLA 125514 ORIGINAL APPROVALS OR TENTATIVE APPROVALS CSVExcelPrint Action DateSubmissionAction TypeSubmission ClassificationReview Priority; Orphan Status Letters, Reviews, Labels, Patient Package InsertNotes 09/04/2014 ORIG-1 Approval N/A; Orphan Label (PDF) Letter (PDF) Review Summary Review (PDF) Showing 1 to 1 of 1 entries SUPPLEMENTS CSVExcelPrint Action DateSubmissionSupplement Categories or Approval TypeLetters, Reviews, Labels, Patient Package Insert Note 12/16/2022 SUPPL-127 Supplement Label (PDF) Letter (PDF) 08/05/2022 SUPPL-133 Supplement Label (PDF) Letter (PDF) 06/21/2022 SUPPL-131 Supplement Label (PDF) Letter (PDF) 05/20/2022 SUPPL-123 Supplement Label (PDF) Letter (PDF) 03/21/2022 SUPPL-110 Supplement Label (PDF) Letter (PDF) 02/04/2022 SUPPL-125 Supplement Label (PDF) Letter (PDF) 02/04/2022 SUPPL-95 Supplement Label is not available on this site. 12/17/2021 SUPPL-120 Supplement Label (PDF) Letter (PDF) 12/03/2021 SUPPL-112 Supplement Label (PDF) Letter (PDF) 11/17/2021 SUPPL-113 Supplement Label (PDF) Letter (PDF) 10/13/2021 SUPPL-122 Supplement Label (PDF) Letter (PDF) 10/13/2021 SUPPL-121 Supplement Label (PDF) Letter (PDF) 08/31/2021 SUPPL-118 Supplement Label (PDF) 08/31/2021 SUPPL-117 Supplement Label (PDF) 08/10/2021 SUPPL-102 Supplement Label (PDF) Letter (PDF) 08/03/2021 SUPPL-104 Supplement Label (PDF) Letter (PDF) 07/26/2021 SUPPL-114 Supplement Label (PDF) Letter (PDF) 07/26/2021 SUPPL-89 Supplement Label (PDF) Letter (PDF) 07/21/2021 SUPPL-105 Supplement Label (PDF) Letter (PDF) 07/01/2021 SUPPL-100 Supplement Label (PDF) Letter (PDF) 06/28/2021 SUPPL-108 Supplement Label (PDF) Letter (PDF) 05/05/2021 SUPPL-97 Supplement Label (PDF) Letter (PDF) 03/30/2021 SUPPL-106 Supplement Letter (PDF) Label is not available on this site. 03/22/2021 SUPPL-96 Supplement Label (PDF) Letter (PDF) 03/16/2021 SUPPL-93 Supplement Label (PDF) Letter (PDF) 03/16/2021 SUPPL-91 Supplement Label (PDF) Letter (PDF) 02/10/2021 SUPPL-98 Supplement Letter (PDF) Label is not available on this site. 11/13/2020 SUPPL-88 Supplement Label (PDF) Letter (PDF) 11/10/2020 SUPPL-48 Supplement Label (PDF) Letter (PDF) 10/14/2020 SUPPL-85 Supplement Label (PDF) Letter (PDF) 10/02/2020 SUPPL-70 Supplement Label (PDF) Letter (PDF) 06/29/2020 SUPPL-84 Supplement Label (PDF) Letter (PDF) 06/24/2020 SUPPL-92 Supplement Label (PDF) Letter (PDF) Review (PDF) 06/24/2020 SUPPL-68 Supplement Label (PDF) Letter (PDF) 06/16/2020 SUPPL-90 Supplement Label (PDF) Letter (PDF) 06/16/2020 SUPPL-71 Supplement Label (PDF) Letter (PDF) 04/28/2020 SUPPL-83 Supplement Label (PDF) Letter (PDF) Summary Review (PDF) 04/28/2020 SUPPL-82 Supplement Letter (PDF) Summary Review (PDF) Label is not available on this site. 04/28/2020 SUPPL-81 Supplement Letter (PDF) Summary Review (PDF) Label is not available on this site. 04/28/2020 SUPPL-80 Supplement Letter (PDF) Summary Review (PDF) Label is not available on this site. 04/28/2020 SUPPL-79 Supplement Label (PDF) Letter (PDF) 04/28/2020 SUPPL-78 Supplement Letter (PDF) Summary Review (PDF) Label is not available on this site. 04/28/2020 SUPPL-77 Supplement Letter (PDF) Summary Review (PDF) Label is not available on this site. 04/28/2020 SUPPL-76 Supplement Letter (PDF) Summary Review (PDF) Label is not available on this site. 04/28/2020 SUPPL-69 Supplement Letter (PDF) Summary Review (PDF) Label is not available on this site. 04/28/2020 SUPPL-64 Supplement Letter (PDF) Summary Review (PDF) Label is not available on this site. 04/28/2020 SUPPL-63 Supplement Letter (PDF) Summary Review (PDF) Label is not available on this site. 04/28/2020 SUPPL-62 Supplement Letter (PDF) Summary Review (PDF) Label is not available on this site. 04/28/2020 SUPPL-61 Supplement Letter (PDF) Summary Review (PDF) Label is not available on this site. 04/28/2020 SUPPL-60 Supplement Letter (PDF) Summary Review (PDF) Label is not available on this site. 04/28/2020 SUPPL-59 Supplement Letter (PDF) Summary Review (PDF) Label is not available on this site. 01/09/2020 SUPPL-67 Supplement Label (PDF) Letter (PDF) 01/08/2020 SUPPL-66 Supplement Label (PDF) Letter (PDF) 09/17/2019 SUPPL-65 Supplement Label (PDF) Letter (PDF) 07/30/2019 SUPPL-56 Supplement Label (PDF) Letter (PDF) 07/30/2019 SUPPL-55 Supplement Label (PDF) Letter (PDF) 06/17/2019 SUPPL-53 Supplement Label (PDF) Letter (PDF) 06/10/2019 SUPPL-52 Supplement Label (PDF) Letter (PDF) 04/19/2019 SUPPL-54 Supplement Label (PDF) Letter (PDF) 04/11/2019 SUPPL-47 Supplement Label (PDF) Letter (PDF) Review (PDF) 02/15/2019 SUPPL-40 Supplement Label (PDF) Letter (PDF) 12/28/2018 SUPPL-37 Supplement Label (PDF) Letter (PDF) 12/19/2018 SUPPL-45 Supplement Label (PDF) Letter (PDF) Review (PDF) 11/09/2018 SUPPL-42 Supplement Label (PDF) Letter (PDF) 10/30/2018 SUPPL-41 Supplement Label (PDF) Letter (PDF) 08/20/2018 SUPPL-35 Supplement Label (PDF) Letter (PDF) 08/16/2018 SUPPL-46 Supplement Label (PDF) Letter (PDF) 06/19/2018 SUPPL-43 Supplement Label (PDF) Letter (PDF) 06/13/2018 SUPPL-30 Supplement Label (PDF) Letter (PDF) 06/12/2018 SUPPL-34 Supplement Label (PDF) Letter (PDF) 11/29/2017 SUPPL-31 Supplement Label (PDF) Letter (PDF) 09/22/2017 SUPPL-24 Supplement Label (PDF) Letter (PDF) Review 07/27/2017 SUPPL-23 Supplement Label (PDF) Letter (PDF) 07/27/2017 SUPPL-19 Supplement Label (PDF) Letter (PDF) 05/23/2017 SUPPL-14 Supplement Label (PDF) Letter (PDF) Review (PDF) 05/18/2017 SUPPL-18 Supplement Label (PDF) Letter (PDF) 05/18/2017 SUPPL-17 Supplement Label (PDF) Letter (PDF) 05/17/2017 SUPPL-13 Supplement Label (PDF) Letter (PDF) 05/10/2017 SUPPL-16 Supplement Label (PDF) Letter (PDF) 03/14/2017 SUPPL-15 Supplement Label (PDF) Letter (PDF) 10/24/2016 SUPPL-12 Supplement Label (PDF) Letter (PDF) 10/24/2016 SUPPL-8 Supplement Label (PDF) Letter (PDF) 08/05/2016 SUPPL-9 Supplement Label (PDF) Letter (PDF) 12/18/2015 SUPPL-6 Supplement Label (PDF) Letter (PDF) 12/18/2015 SUPPL-4 Supplement Label (PDF) Letter (PDF) 10/02/2015 SUPPL-5 Supplement Label (PDF) Letter (PDF) 06/19/2015 SUPPL-3 Supplement Label (PDF) Letter (PDF) Showing 1 to 87 of 87 entries LABELS FOR BLA 125514 CSVExcelPrint Action DateSubmissionSupplement Categories or Approval TypeLetters, Reviews, Labels, Patient Package InsertNote 12/16/2022 SUPPL-127 Efficacy-Labeling Change With Clinical Data Label (PDF) 08/05/2022 SUPPL-133 Labeling-Package Insert Label (PDF) 08/05/2022 SUPPL-133 Labeling-Medication Guide Label (PDF) 06/21/2022 SUPPL-131 Labeling-Patient Package Insert Label (PDF) 05/20/2022 SUPPL-123 Efficacy-Labeling Change With Clinical Data Label (PDF) 03/21/2022 SUPPL-110 Efficacy-New Indication Label (PDF) 02/04/2022 SUPPL-125 Labeling-Medication Guide Label (PDF) 02/04/2022 SUPPL-125 Labeling-Package Insert Label (PDF) 12/17/2021 SUPPL-120 Efficacy-Labeling Change With Clinical Data Label (PDF) 12/03/2021 SUPPL-112 Efficacy-New Indication Label (PDF) 11/17/2021 SUPPL-113 Efficacy-New Indication Label (PDF) 10/13/2021 SUPPL-122 Efficacy-Accelerated Approval Label (PDF) 10/13/2021 SUPPL-121 Efficacy-New Indication Label (PDF) 08/31/2021 SUPPL-118 Efficacy-New Patient Population Label (PDF) 08/31/2021 SUPPL-117 Efficacy-Accelerated Approval Label (PDF) 08/10/2021 SUPPL-102 Efficacy-New Indication Label (PDF) 08/03/2021 SUPPL-104 Labeling-Package Insert Label (PDF) 07/26/2021 SUPPL-114 Efficacy-New Indication Label (PDF) 07/26/2021 SUPPL-89 Efficacy-New Indication Label (PDF) 07/21/2021 SUPPL-105 Efficacy-New Indication Label (PDF) 07/01/2021 SUPPL-100 Efficacy-New Indication Label (PDF) 06/28/2021 SUPPL-108 Labeling-Package Insert Label (PDF) 06/28/2021 SUPPL-108 Labeling-Medication Guide Label (PDF) 05/05/2021 SUPPL-97 Efficacy-New Indication Label (PDF) 03/22/2021 SUPPL-96 Efficacy-New Indication Label (PDF) 03/16/2021 SUPPL-93 Efficacy-Labeling Change With Clinical Data Label (PDF) 03/16/2021 SUPPL-91 Efficacy-Labeling Change With Clinical Data Label (PDF) 11/13/2020 SUPPL-88 Efficacy-New Indication Label (PDF) 11/10/2020 SUPPL-48 Labeling-Package Insert Label (PDF) 10/14/2020 SUPPL-85 Efficacy-New Indication Label (PDF) 10/02/2020 SUPPL-70 Efficacy-Labeling Change With Clinical Data Label (PDF) 06/29/2020 SUPPL-84 Efficacy-New Indication Label (PDF) 06/24/2020 SUPPL-92 Efficacy-New Dosing Regimen Label (PDF) 06/24/2020 SUPPL-68 Efficacy-New Indication Label (PDF) 06/16/2020 SUPPL-90 Efficacy-New Dosing Regimen Label (PDF) 06/16/2020 SUPPL-71 Efficacy-New Indication Label (PDF) 04/28/2020 SUPPL-83 Efficacy-New Dosing Regimen Label (PDF) 04/28/2020 SUPPL-79 Efficacy-New Dosing Regimen Label (PDF) 01/09/2020 SUPPL-67 Labeling-Package Insert Label (PDF) 01/09/2020 SUPPL-67 Labeling-Medication Guide Label (PDF) 01/08/2020 SUPPL-66 Efficacy-Labeling Change With Clinical Data Label (PDF) 09/17/2019 SUPPL-65 Efficacy-New Indication Label (PDF) 07/30/2019 SUPPL-56 Efficacy-New Indication Label (PDF) 07/30/2019 SUPPL-55 Efficacy-New Indication Label (PDF) 06/17/2019 SUPPL-53 Efficacy-New Indication Label (PDF) 06/10/2019 SUPPL-52 Efficacy-Accelerated Approval Label (PDF) 04/19/2019 SUPPL-54 Efficacy-Labeling Change With Clinical Data Label (PDF) 04/11/2019 SUPPL-47 Efficacy-New Indication Label (PDF) 02/15/2019 SUPPL-40 Efficacy-New Indication Label (PDF) 12/28/2018 SUPPL-37 Efficacy-Labeling Change With Clinical Data Label (PDF) 12/19/2018 SUPPL-45 Efficacy-New Indication Label (PDF) 11/09/2018 SUPPL-42 Efficacy-New Indication Label (PDF) 10/30/2018 SUPPL-41 Efficacy-New Indication Label (PDF) 08/20/2018 SUPPL-35 Efficacy-Accelerated Approval Label (PDF) 08/16/2018 SUPPL-46 Efficacy-Labeling Change With Clinical Data Label (PDF) 06/19/2018 SUPPL-43 Efficacy-Labeling Change With Clinical Data Label (PDF) 06/13/2018 SUPPL-30 Efficacy-New Indication Label (PDF) 06/12/2018 SUPPL-34 Efficacy-New Indication Label (PDF) 11/29/2017 SUPPL-31 Labeling-Package Insert Label (PDF) 09/22/2017 SUPPL-24 Efficacy-New Indication Label (PDF) 07/27/2017 SUPPL-23 Labeling-Package Insert Label (PDF) 07/27/2017 SUPPL-19 Labeling-Medication Guide Label (PDF) 07/27/2017 SUPPL-19 Labeling-Package Insert Label (PDF) 05/23/2017 SUPPL-14 Efficacy-New Indication Label (PDF) 05/18/2017 SUPPL-18 Efficacy-New Indication Label (PDF) 05/18/2017 SUPPL-17 Efficacy-New Indication Label (PDF) 05/17/2017 SUPPL-13 Efficacy-New Dosing Regimen Label (PDF) 05/10/2017 SUPPL-16 Efficacy-New Indication Label (PDF) 03/14/2017 SUPPL-15 Efficacy-New Indication Label (PDF) 10/24/2016 SUPPL-12 Efficacy-New Indication Label (PDF) 10/24/2016 SUPPL-8 Efficacy-Accelerated Approval Label (PDF) 08/05/2016 SUPPL-9 Efficacy-New Indication Label (PDF) 12/18/2015 SUPPL-6 Efficacy-New Indication Label (PDF) 12/18/2015 SUPPL-4 Efficacy-Accelerated Approval Label (PDF) 10/02/2015 SUPPL-5 Efficacy-New Indication Label (PDF) 06/19/2015 SUPPL-3 Labeling-Medication Guide Label (PDF) 06/19/2015 SUPPL-3 Labeling-Package Insert Label (PDF) 09/04/2014 ORIG-1 Approval Label (PDF) Showing 1 to 78 of 78 entries FOOTER LINKS * FDA Archive * About FDA * Accessibility * Visitor Information * Website Policies / Privacy * No FEAR Act * Vulnerability Disclosure Policy * FOIA * HHS.gov * USA.gov Contact FDA Follow FDA on Facebook Follow FDA on Twitter View FDA videos on YouTube Subscribe to FDA RSS feeds FDA Homepage Contact Number 1-888-INFO-FDA (1-888-463-6332) Back to Top