Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 202192
Company: INCYTE CORP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
JAKAFI RUXOLITINIB PHOSPHATE EQ 5MG BASE TABLET;ORAL Prescription None Yes No
JAKAFI RUXOLITINIB PHOSPHATE EQ 10MG BASE TABLET;ORAL Prescription None Yes No
JAKAFI RUXOLITINIB PHOSPHATE EQ 15MG BASE TABLET;ORAL Prescription None Yes No
JAKAFI RUXOLITINIB PHOSPHATE EQ 20MG BASE TABLET;ORAL Prescription None Yes No
JAKAFI RUXOLITINIB PHOSPHATE EQ 25MG BASE TABLET;ORAL Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/16/2011 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202192lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202192s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202192Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202192Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/24/2019 SUPPL-17 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202192s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/202192Orig1s017ltr.pdf
10/26/2018 SUPPL-16 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202192s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202192Orig1s016ltr.pdf
12/06/2017 SUPPL-15 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202192s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202192Orig1s015ltr.pdf
10/10/2017 SUPPL-14 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202192s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202192Orig1s014ltr.pdf
03/10/2016 SUPPL-12 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202192s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202192Orig1s012ltr.pdf
10/06/2015 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

12/02/2015 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

12/15/2014 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202192s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202192Orig1s009ltr.pdf
12/04/2014 SUPPL-8 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202192s008lblPi.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202192Orig1s008ltr.pdf
05/30/2014 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

07/25/2014 SUPPL-6 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202192s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202192Orig1s006ltr.pdf
11/25/2013 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202192s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202192Orig1s005ltr.pdf
11/07/2013 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

06/12/2013 SUPPL-3 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202192s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202192Orig1s003ltr.pdf
06/21/2012 SUPPL-1 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202192s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202192s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/24/2019 SUPPL-17 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202192s017lbl.pdf
10/26/2018 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202192s016lbl.pdf
12/06/2017 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202192s015lbl.pdf
12/06/2017 SUPPL-15 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202192s015lbl.pdf
10/10/2017 SUPPL-14 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202192s014lbl.pdf
03/10/2016 SUPPL-12 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202192s012lbl.pdf
12/15/2014 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202192s009lbl.pdf
12/04/2014 SUPPL-8 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202192s008lblPi.pdf
07/25/2014 SUPPL-6 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202192s006lbl.pdf
11/25/2013 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202192s005lbl.pdf
06/12/2013 SUPPL-3 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202192s003lbl.pdf
06/21/2012 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202192s001lbl.pdf
11/16/2011 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202192lbl.pdf

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