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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 203756
Company: EXELIXIS

Summary Review

Products on NDA 203756

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
COMETRIQ	CABOZANTINIB S-MALATE	EQ 20MG BASE	CAPSULE;ORAL	Prescription	None	Yes	No
COMETRIQ	CABOZANTINIB S-MALATE	EQ 80MG BASE	CAPSULE;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 203756

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/29/2012	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/2012/203756lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203756Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203756Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203756Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/23/2023	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/203756s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/203756Orig1s011ltr.pdf
10/22/2020	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203756s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/203756Orig1s009ltr.pdf
01/31/2020	SUPPL-8	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203756s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/203756Orig1s008ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/203756Orig1s008.pdf
01/12/2018	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203756s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203756Orig1s005ltr.pdf
10/05/2017	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203756s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203756Orig1s004ltr.pdf
05/20/2016	SUPPL-2	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203756s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203756Orig1s002ltr.pdf
02/28/2014	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 203756

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/23/2023	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/203756s011lbl.pdf
10/22/2020	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203756s009lbl.pdf
01/31/2020	SUPPL-8	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203756s008lbl.pdf
01/31/2020	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203756s008lbl.pdf
01/12/2018	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203756s005lbl.pdf
10/05/2017	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203756s004lbl.pdf
05/20/2016	SUPPL-2	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203756s002lbl.pdf
11/29/2012	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203756lbl.pdf

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