Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 202806
Company: NOVARTIS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TAFINLAR DABRAFENIB MESYLATE EQ 50MG BASE CAPSULE;ORAL Prescription None Yes No
TAFINLAR DABRAFENIB MESYLATE EQ 75MG BASE CAPSULE;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
05/29/2013 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD; Orphan Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202806s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202806Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/202806Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202806Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/09/2020 SUPPL-15 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202806s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/202806Orig1s015ltr.pdf
07/16/2019 SUPPL-13 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202806s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/202806Orig1s013ltr.pdf
10/06/2019 SUPPL-12 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202806s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/202806Orig1s012ltr.pdf
05/04/2018 SUPPL-10 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202806s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202806Orig1s010ltr.pdf
04/20/2018 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202806s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202806Orig1s009ltr.pdf
04/30/2018 SUPPL-8 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202806s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202806Orig1s008ltr.pdf
06/16/2017 SUPPL-7 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202806s007lbl.pdf
06/22/2017 SUPPL-6 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202806s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202806Orig1s006ltr.pdf
06/16/2016 SUPPL-5 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202806s005lbl.pdf
11/20/2015 SUPPL-4 Efficacy-Accelerated Approval Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202806s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202806Orig1s004ltr.pdf
08/25/2014 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.
01/09/2014 SUPPL-2 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202806s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202806Orig1s002ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/202806Orig1s002.pdf
12/26/2013 SUPPL-1 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202806s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202806Orig1s001ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
04/09/2020 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202806s015lbl.pdf
10/06/2019 SUPPL-12 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202806s012lbl.pdf
07/16/2019 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202806s013lbl.pdf
05/04/2018 SUPPL-10 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202806s010lbl.pdf
04/30/2018 SUPPL-8 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202806s008lbl.pdf
04/20/2018 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202806s009lbl.pdf
06/22/2017 SUPPL-6 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202806s006lbl.pdf
06/16/2017 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202806s007lbl.pdf
06/16/2016 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202806s005lbl.pdf
11/20/2015 SUPPL-4 Efficacy-Accelerated Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202806s004lbl.pdf
01/09/2014 SUPPL-2 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202806s002lbl.pdf
12/26/2013 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202806s001lbl.pdf
05/29/2013 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202806s000lbl.pdf

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