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
ADCETRIS از شرکت SEATTLE GENETICS
Biologic License Application (BLA): 125388
Company: SEATTLE GENETICS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ADCETRIS | BRENTUXIMAB VEDOTIN | 50MG/VIAL | INJECTABLE; INJECTION | Prescription |
None |
No | 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 |
|---|---|---|---|---|---|---|---|
| 08/19/2011 | ORIG-1 | Approval |
N/A; Orphan |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125388s000,125399s000lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/15/2019 | SUPPL-100 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125388s100lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125388Orig1s100ltr.pdf |
||
| 11/16/2018 | SUPPL-99 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125388s099lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125388Orig1s099ltr.pdf |
||
| 03/20/2018 | SUPPL-97 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125388s097lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125388Orig1s097ltr.pdf |
||
| 11/09/2017 | SUPPL-94 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125388s094lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125388Orig1s094ltr.pdf |
||
| 09/28/2016 | SUPPL-88 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125388s088lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125388Orig1s088ltr.pdf |
||
| 03/04/2016 | SUPPL-84 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125388s084lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125388Orig1s084ltr.pdf |
||
| 08/17/2015 | SUPPL-81 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125388s080lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125388Orig1s080s081Ltr.pdf |
||
| 08/17/2015 | SUPPL-80 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125388s080lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125388Orig1s080s081Ltr.pdf |
||
| 11/23/2014 | SUPPL-78 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125388_S056S078lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125388Orig1s056,s078ltr.pdf |
||
| 11/23/2014 | SUPPL-56 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125388_S056S078lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125388Orig1s056,s078ltr.pdf |
||
| 08/19/2013 | SUPPL-45 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125388s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125388Orig1s045ltr.pdf |
||
| 01/13/2012 | SUPPL-11 | Supplement |
Label is not available on this site. |
||
| 08/19/2011 | SUPPL-6 | Supplement |
Label is not available on this site. |
||
| 01/13/2012 | SUPPL-5 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125388s0005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125388s005ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/15/2019 | SUPPL-100 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125388s100lbl.pdf | |
| 11/16/2018 | SUPPL-99 |
Efficacy-New Indication |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125388s099lbl.pdf | |
| 03/20/2018 | SUPPL-97 |
Efficacy-New Indication |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125388s097lbl.pdf | |
| 11/09/2017 | SUPPL-94 |
Efficacy-New Indication |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125388s094lbl.pdf | |
| 09/28/2016 | SUPPL-88 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125388s088lbl.pdf | |
| 03/04/2016 | SUPPL-84 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125388s084lbl.pdf | |
| 08/17/2015 | SUPPL-81 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125388s080lbl.pdf | |
| 08/17/2015 | SUPPL-80 |
Efficacy-New Indication |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125388s080lbl.pdf | |
| 11/23/2014 | SUPPL-78 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125388_S056S078lbl.pdf | |
| 11/23/2014 | SUPPL-56 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125388_S056S078lbl.pdf | |
| 08/19/2013 | SUPPL-45 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125388s045lbl.pdf | |
| 01/13/2012 | SUPPL-5 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125388s0005lbl.pdf | |
| 08/19/2011 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125388s000,125399s000lbl.pdf |
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