Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 203756
Company: EXELIXIS
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 |