Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 206910
Company: NOVARTIS PHARMS CORP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
JADENU DEFERASIROX 90MG TABLET;ORAL Prescription None Yes No
JADENU DEFERASIROX 180MG TABLET;ORAL Prescription None Yes No
JADENU DEFERASIROX 360MG 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
03/30/2015 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206910s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206910Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206910Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/24/2019 SUPPL-14 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206910s014,207968s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/206910Orig1s014, 207968Orig1s008ltr.pdf
07/26/2019 SUPPL-12 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206910s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/206910Orig1s012ltr.pdf
12/12/2018 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206910s009s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206910Orig1s009, 206910Orig1s011ltr.pdf
08/03/2018 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206910s010,207968s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206910Orig1s10,207968Orig1s005Ltr.pdf
12/12/2018 SUPPL-9 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206910s009s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206910Orig1s009, 206910Orig1s011ltr.pdf
02/16/2018 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206910s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206910Orig1s007ltr.pdf
05/11/2018 SUPPL-6 Efficacy-Accelerated Approval Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206910s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206910Orig1s006ltr.pdf
01/26/2018 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206910s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206910Orig1s005ltr.pdf
08/12/2016 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206910s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206910Orig1s004ltr.pdf
10/22/2015 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206910s001s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206910Orig1s001,s003ltr.pdf
11/06/2015 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

10/22/2015 SUPPL-1 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206910s001s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206910Orig1s001,s003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/26/2019 SUPPL-12 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206910s012lbl.pdf
05/24/2019 SUPPL-14 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206910s014,207968s008lbl.pdf
12/12/2018 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206910s009s011lbl.pdf
12/12/2018 SUPPL-9 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206910s009s011lbl.pdf
08/03/2018 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206910s010,207968s005lbl.pdf
05/11/2018 SUPPL-6 Efficacy-Accelerated Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206910s006lbl.pdf
02/16/2018 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206910s007lbl.pdf
01/26/2018 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206910s005lbl.pdf
08/12/2016 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206910s004lbl.pdf
10/22/2015 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206910s001s003lbl.pdf
10/22/2015 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206910s001s003lbl.pdf
03/30/2015 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206910s000lbl.pdf

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