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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 203756
Company: EXELIXIS
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
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-Package Insert, Labeling-Container/Carton Labels 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.

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-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203756s008lbl.pdf
01/31/2020 SUPPL-8 Labeling-Container/Carton Labels 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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