Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 210496
Company: ARRAY BIOPHARMA INC
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 | STANDARD; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210496lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210496Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210496Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/20/2024 | SUPPL-17 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210496s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/210496Orig1s017ltr.pdf | |
09/12/2024 | SUPPL-16 | Efficacy-Labeling Change With Clinical Data, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210496s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/210496Orig1s016ltr.pdf | |
10/13/2023 | SUPPL-15 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210496s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/210496Orig1s015ltr.pdf | |
10/11/2023 | SUPPL-14 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210496s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/210496Orig1s014ltr.pdf | |
02/11/2022 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210496s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/210496Orig1s013ltr.pdf | |
04/08/2020 | SUPPL-6 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
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 |
Label (PDF)
Letter (PDF) |
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 |
Label (PDF)
Letter (PDF) |
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 |
---|---|---|---|---|---|
12/20/2024 | SUPPL-17 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210496s017lbl.pdf | |
09/12/2024 | SUPPL-16 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210496s016lbl.pdf | |
09/12/2024 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210496s016lbl.pdf | |
10/13/2023 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210496s015lbl.pdf | |
10/11/2023 | SUPPL-14 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210496s014lbl.pdf | |
02/11/2022 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210496s013lbl.pdf | |
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 |