Drugs@FDA: FDA-Approved Drugs

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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 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
08/31/2021 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
06/28/2021 SUPPL-108 Supplement Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125514s108lbl.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
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)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125514s055s056lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125514Orig1s055,s056ltr.pdf
07/30/2019 SUPPL-55 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125514s055s056lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125514Orig1s055,s056ltr.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)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125514s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125514Orig1s047ltr.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
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-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125514s108lbl.pdf
06/28/2021 SUPPL-108 Labeling-Medication Guide 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-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-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125514s003lbl.pdf
06/19/2015 SUPPL-3 Labeling-Medication Guide 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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