Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 125514
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
09/22/2017 SUPPL-24 Supplement Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125514s024lbl.pdf
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
09/22/2017 SUPPL-24 Labeling 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

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