An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 203085
Company: BAYER HLTHCARE

Summary Review

Products on NDA 203085

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
STIVARGA	REGORAFENIB	40MG	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 203085

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
12/10/2020	SUPPL-14	Manufacturing (CMC)	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203085Orig1s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/203085Orig1s014ltr.pdf
07/21/2020	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203085s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/203085Orig1s013ltr.pdf
09/24/2020	SUPPL-12	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/203085Orig1s012ltr.pdf
02/13/2020	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203085s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/203085Orig1s011ltr.pdf
07/31/2019	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203085s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/203085Orig1s010ltr.pdf
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) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203085s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203085Orig1s007.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/203085Orig1s007.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

Labels for NDA 203085

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/10/2020	SUPPL-14	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203085Orig1s014lbl.pdf
07/21/2020	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203085s013lbl.pdf
02/13/2020	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203085s011lbl.pdf
07/31/2019	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203085s010lbl.pdf
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

Top