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
ALUNBRIG از شرکت TAKEDA PHARMS USA
New Drug Application (NDA): 208772
Company: TAKEDA PHARMS USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ALUNBRIG | BRIGATINIB | 30MG | TABLET;ORAL | Prescription |
None |
Yes | No |
| ALUNBRIG | BRIGATINIB | 90MG | TABLET;ORAL | Prescription |
None |
Yes | No |
| ALUNBRIG | BRIGATINIB | 180MG | 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 |
|---|---|---|---|---|---|---|---|
| 04/28/2017 | ORIG-1 | Approval |
Type 1 – New Molecular Entity |
PRIORITY; Orphan |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208772lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/22/2020 | SUPPL-8 | Efficacy-New Indication |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208772s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208772Orig1s008ltr.pdf |
||
| 12/21/2018 | SUPPL-4 | Efficacy-Labeling Change With Clinical Data |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208772s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208772Orig1s004Ltr.pdf |
||
| 10/02/2017 | SUPPL-2 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/22/2020 | SUPPL-8 |
Efficacy-New Indication |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208772s008lbl.pdf | |
| 12/21/2018 | SUPPL-4 |
Efficacy-Labeling Change With Clinical Data |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208772s004lbl.pdf | |
| 04/28/2017 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208772lbl.pdf |
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