Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 202429
Company: HOFFMANN LA ROCHE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZELBORAF VEMURAFENIB 240MG 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
08/17/2011 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/2011/202429s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202429Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202429s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202429Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/13/2017 SUPPL-15 Labeling-Package Insert, Labeling-Medication Guide Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202429Orig1s015ltr.pdf
09/13/2017 SUPPL-14 Efficacy-Labeling Change With Clinical Data Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202429Orig1s014ltr.pdf
04/17/2017 SUPPL-12 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202429s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202429Orig1s012ltr.pdf
05/09/2016 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202429s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202429Orig1s010ltr.pdf
08/31/2016 SUPPL-9 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202429s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202429Orig1s009ltr.pdf
08/11/2015 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202429s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202429Orig1s008ltr.pdf
09/23/2014 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

11/25/2014 SUPPL-6 Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202429s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202429Orig1s006ltr.pdf
02/06/2014 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202429s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202429Orig1s005ltr.pdf
03/19/2014 SUPPL-4 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202429s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202429Orig1s004ltr.pdf
07/03/2013 SUPPL-3 Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202429s002s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202429Orig1s002,s003ltr.pdf
07/03/2013 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202429s002s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202429Orig1s002,s003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/17/2017 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202429s012lbl.pdf
08/31/2016 SUPPL-9 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202429s009lbl.pdf
05/09/2016 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202429s010lbl.pdf
08/11/2015 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202429s008lbl.pdf
11/25/2014 SUPPL-6 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202429s006lbl.pdf
03/19/2014 SUPPL-4 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202429s004lbl.pdf
02/06/2014 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202429s005lbl.pdf
07/03/2013 SUPPL-3 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202429s002s003lbl.pdf
07/03/2013 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202429s002s003lbl.pdf
08/17/2011 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202429s000lbl.pdf

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