اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
COMETRIQ از شرکت EXELIXIS
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 | Yes |
| COMETRIQ | CABOZANTINIB S-MALATE | EQ 80MG BASE | CAPSULE;ORAL | Prescription |
None |
Yes | No |
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 |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203756lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/22/2020 | SUPPL-9 | Labeling-Package Insert |
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 |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203756s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/203756Orig1s008ltr.pdf |
||
| 01/12/2018 | SUPPL-5 | Labeling-Package Insert |
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 |
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 |
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 |
|---|---|---|---|---|---|
| 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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