Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 207968
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
JADENU SPRINKLE DEFERASIROX 90MG GRANULE;ORAL Prescription None Yes No
JADENU SPRINKLE DEFERASIROX 180MG GRANULE;ORAL Prescription None Yes No
JADENU SPRINKLE DEFERASIROX 360MG GRANULE;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
05/18/2017 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD; Orphan Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207968s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207968Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207968Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207968Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/24/2019 SUPPL-8 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
07/25/2019 SUPPL-7 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207968s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/207968Orig1s007ltr.pdf
12/12/2018 SUPPL-6 Labeling-Package Insert Label
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207968s004s006lbl https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207968Orig1s004, 207968Orig1s006ltr.pdf
08/03/2018 SUPPL-5 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-4 Efficacy-Labeling Change With Clinical Data Label
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207968s004s006lbl https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207968Orig1s004, 207968Orig1s006ltr.pdf
02/16/2018 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207968s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207968Orig1s002ltr.pdf
05/11/2018 SUPPL-1 Efficacy-Accelerated Approval Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207968s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207968Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/25/2019 SUPPL-7 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207968s007lbl.pdf
05/24/2019 SUPPL-8 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206910s014,207968s008lbl.pdf
12/12/2018 SUPPL-6 Labeling-Package Insert https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207968s004s006lbl
12/12/2018 SUPPL-4 Efficacy-Labeling Change With Clinical Data https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207968s004s006lbl
08/03/2018 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206910s010,207968s005lbl.pdf
05/11/2018 SUPPL-1 Efficacy-Accelerated Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207968s001lbl.pdf
02/16/2018 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207968s002lbl.pdf
05/18/2017 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207968s000lbl.pdf

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