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
BRAFTOVI از شرکت ARRAY BIOPHARMA INC
New Drug Application (NDA): 210496
Company: ARRAY BIOPHARMA INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BRAFTOVI | ENCORAFENIB | 50MG | CAPSULE;ORAL | Discontinued |
None |
Yes | No |
| BRAFTOVI | ENCORAFENIB | 75MG | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 06/27/2018 | ORIG-1 | Approval |
Type 1 – New Molecular Entity and Type 4 – New Combination |
STANDARD; Orphan |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210496lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/08/2020 | SUPPL-6 | Efficacy-New Indication |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210496s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/210496Orig1s006ltr.pdf |
||
| 05/24/2019 | SUPPL-3 | Efficacy-New Dosing Regimen |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210496s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210496Orig1s003ltr.pdf |
||
| 01/23/2019 | SUPPL-1 | Efficacy-Labeling Change With Clinical Data |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210496s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210496Orig1s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/08/2020 | SUPPL-6 |
Efficacy-New Indication |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210496s006lbl.pdf | |
| 05/24/2019 | SUPPL-3 |
Efficacy-New Dosing Regimen |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210496s003lbl.pdf | |
| 01/23/2019 | SUPPL-1 |
Efficacy-Labeling Change With Clinical Data |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210496s001lbl.pdf | |
| 06/27/2018 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210496lbl.pdf |
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