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CABOMETYX از شرکت EXELIXIS INC

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داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است

CABOMETYX از شرکت EXELIXIS INC

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
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

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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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