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
BLINCYTO از شرکت AMGEN
Biologic License Application (BLA): 125557
Company: AMGEN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BLINCYTO | BLINATUMOMAB | 35MCG | 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 |
|---|---|---|---|---|---|---|---|
| 12/03/2014 | ORIG-1 | Approval |
N/A; Orphan |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125557lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/11/2021 | SUPPL-20 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125557s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125557Orig1s020ltr.pdf |
||
| 03/11/2021 | SUPPL-19 | Supplement |
Label is not available on this site. |
||
| 03/11/2021 | SUPPL-18 | Supplement |
Label is not available on this site. |
||
| 03/20/2020 | SUPPL-17 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125557s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125557Orig1s017ltr.pdf |
||
| 04/18/2019 | SUPPL-16 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125557s015s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125557Orig1s015, s016ltr.pdf |
||
| 04/18/2019 | SUPPL-15 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125557s015s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125557Orig1s015, s016ltr.pdf |
||
| 04/10/2018 | SUPPL-14 | Supplement |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125557Orig1s014ltr.pdf |
|
| 03/29/2018 | SUPPL-13 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125557s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125557Orig1s013ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/125557Orig1s013.pdf |
||
| 11/30/2017 | SUPPL-12 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125557s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125557Orig1s012ltr.pdf |
||
| 07/11/2017 | SUPPL-8 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125557s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125557Orig1s008ltr.pdf |
||
| 05/03/2017 | SUPPL-7 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125557s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125557Orig1s007ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/125557Orig1s007.pdf |
||
| 08/30/2016 | SUPPL-6 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125557s005s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125557Orig1s005,s006ltr.pdf |
||
| 08/30/2016 | SUPPL-5 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125557s005s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125557Orig1s005,s006ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/125557Orig1s005TOC.cfm |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/11/2021 | SUPPL-20 |
Efficacy-Labeling Change With Clinical Data |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125557s020lbl.pdf | |
| 03/20/2020 | SUPPL-17 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125557s017lbl.pdf | |
| 04/18/2019 | SUPPL-16 |
REMS-Modified |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125557s015s016lbl.pdf | |
| 04/18/2019 | SUPPL-15 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125557s015s016lbl.pdf | |
| 03/29/2018 | SUPPL-13 |
Efficacy-New Indication |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125557s013lbl.pdf | |
| 11/30/2017 | SUPPL-12 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125557s012lbl.pdf | |
| 07/11/2017 | SUPPL-8 |
Efficacy-Accelerated Approval |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125557s008lbl.pdf | |
| 05/03/2017 | SUPPL-7 |
Labeling-Medication Guide |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125557s007lbl.pdf | |
| 05/03/2017 | SUPPL-7 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125557s007lbl.pdf | |
| 08/30/2016 | SUPPL-6 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125557s005s006lbl.pdf | |
| 08/30/2016 | SUPPL-6 |
Labeling-Medication Guide |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125557s005s006lbl.pdf | |
| 08/30/2016 | SUPPL-5 |
Efficacy-Labeling Change With Clinical Data |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125557s005s006lbl.pdf | |
| 12/03/2014 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125557lbl.pdf |
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