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
CAPRELSA از شرکت GENZYME CORP
New Drug Application (NDA): 022405
Company: GENZYME CORP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CAPRELSA | VANDETANIB | 100MG | TABLET;ORAL | Prescription |
None |
Yes | No |
| CAPRELSA | VANDETANIB | 300MG | 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 |
|---|---|---|---|---|---|---|---|
| 04/06/2011 | ORIG-1 | Approval |
Type 1 – New Molecular Entity |
PRIORITY; Orphan |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022405s000lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/15/2020 | SUPPL-17 | Labeling-Package Insert, Labeling-Patient Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022405s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022405Orig1s017replacementltr.pdf |
||
| 06/05/2020 | SUPPL-16 | Labeling-Medication Guide, Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022405s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022405Orig1s016ltr.pdf |
||
| 10/12/2018 | SUPPL-14 | Efficacy-Labeling Change With Clinical Data |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022405s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022405Orig1s14ltr.pdf |
||
| 02/24/2017 | SUPPL-11 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 07/28/2016 | SUPPL-10 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022405s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022405Orig1s010ltr.pdf |
||
| 05/16/2017 | SUPPL-9 | REMS – ASSESSMENT – MODIFIED |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022405Orig1s009ltr.pdf |
|
| 03/31/2014 | SUPPL-7 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022405s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022405Orig1s007ltr.pdf |
||
| 11/27/2013 | SUPPL-5 | Labeling-Medication Guide |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022405Orig1s005ltr.pdf |
|
| 07/03/2013 | SUPPL-4 | Labeling-Patient Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022405s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022405Orig1s004ltr.pdf |
||
| 10/09/2012 | SUPPL-3 | Labeling-Package Insert, Labeling-Medication Guide |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022405s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022405Orig1s003ltr.pdf |
||
| 06/22/2011 | SUPPL-1 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022405s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022405s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/15/2020 | SUPPL-17 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022405s017lbl.pdf | |
| 06/15/2020 | SUPPL-17 |
Labeling-Patient Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022405s017lbl.pdf | |
| 06/05/2020 | SUPPL-16 |
Labeling-Medication Guide |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022405s016lbl.pdf | |
| 06/05/2020 | SUPPL-16 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022405s016lbl.pdf | |
| 10/12/2018 | SUPPL-14 |
Efficacy-Labeling Change With Clinical Data |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022405s014lbl.pdf | |
| 07/28/2016 | SUPPL-10 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022405s010lbl.pdf | |
| 03/31/2014 | SUPPL-7 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022405s007lbl.pdf | |
| 07/03/2013 | SUPPL-4 |
Labeling-Patient Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022405s004lbl.pdf | |
| 10/09/2012 | SUPPL-3 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022405s003lbl.pdf | |
| 10/09/2012 | SUPPL-3 |
Labeling-Medication Guide |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022405s003lbl.pdf | |
| 06/22/2011 | SUPPL-1 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022405s001lbl.pdf | |
| 04/06/2011 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022405s000lbl.pdf |
نظرات کاربران