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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208692
Company: EXELIXIS INC

Package Labeling

Products on NDA 208692

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CABOMETYX	CABOZANTINIB S-MALATE	EQ 20MG BASE	TABLET;ORAL	Prescription	None	Yes	No
CABOMETYX	CABOZANTINIB S-MALATE	EQ 40MG BASE	TABLET;ORAL	Prescription	None	Yes	No
CABOMETYX	CABOZANTINIB S-MALATE	EQ 60MG BASE	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208692

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/25/2016	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208692s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208692Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208692Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/20/2023	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208692s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208692Orig1s016ltr.pdf
07/14/2022	SUPPL-14	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208692s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208692Orig1s014ltr.pdf
02/13/2023	SUPPL-13	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208692Orig1s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208692Orig1s013ltr.pdf
09/17/2021	SUPPL-12	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208692s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208692Orig1s012correctedltr.pdf
01/22/2021	SUPPL-10	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208692s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208692Orig1s010ltr.pdf
11/05/2020	SUPPL-9	Manufacturing (CMC)-Facility	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208692Orig1s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208692Orig1s009ltr.pdf
07/16/2020	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208692s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208692Orig1s008ltr.pdf
01/31/2020	SUPPL-7	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208692s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208692Orig1s007ltr.pdf
01/14/2019	SUPPL-3	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208692s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208692Orig1s003ltr.pdf
12/19/2017	SUPPL-2	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208692s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208692Orig1s002ltr.pdf
11/16/2017	SUPPL-1	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208692Orig1s001ltr.pdf

Labels for NDA 208692

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/20/2023	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208692s016lbl.pdf
02/13/2023	SUPPL-13	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208692Orig1s013lbl.pdf
02/13/2023	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208692Orig1s013lbl.pdf
07/14/2022	SUPPL-14	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208692s014lbl.pdf
09/17/2021	SUPPL-12	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208692s012lbl.pdf
01/22/2021	SUPPL-10	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208692s010lbl.pdf
11/05/2020	SUPPL-9	Manufacturing (CMC)-Facility	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208692Orig1s009lbl.pdf
07/16/2020	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208692s008lbl.pdf
01/31/2020	SUPPL-7	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208692s007lbl.pdf
01/31/2020	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208692s007lbl.pdf
01/14/2019	SUPPL-3	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208692s003lbl.pdf
12/19/2017	SUPPL-2	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208692s002lbl.pdf
04/25/2016	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208692s000lbl.pdf

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