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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208692
Company: EXELIXIS INC
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
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 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
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
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-Package Insert, Labeling-Container/Carton Labels 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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208692s007lbl.pdf
01/31/2020 SUPPL-7 Labeling-Container/Carton Labels 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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