Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 203085
Company: BAYER HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
STIVARGA REGORAFENIB 40MG 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
09/27/2012 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/2012/203085lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203085Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203085Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203085Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/14/2018 SUPPL-8 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203085s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203085Orig1s008ltr.pdf
04/27/2017 SUPPL-7 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203085s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203085Orig1s007.pdf
08/26/2016 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203085s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203085Orig1s006ltr.pdf
06/07/2016 SUPPL-5 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203085Orig1s005ltr.pdf
04/13/2015 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203085s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203085Orig1s004ltr.pdf
09/13/2013 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

11/10/2014 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

05/29/2013 SUPPL-1 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203085s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203085Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/14/2018 SUPPL-8 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203085s008lbl.pdf
04/27/2017 SUPPL-7 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203085s007lbl.pdf
08/26/2016 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203085s006lbl.pdf
04/13/2015 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203085s004lbl.pdf
05/29/2013 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203085s001lbl.pdf
09/27/2012 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203085lbl.pdf

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