Drugs@FDA: FDA Approved Drug Products
New Drug Application (NDA): 202806
Company: NOVARTIS PHARMS CORP
Company: NOVARTIS PHARMS CORP
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 |
---|---|---|---|---|---|
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) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202806s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202806Orig1s002ltr.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 |
---|---|---|---|---|---|
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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