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Drugs@FDA: FDA-Approved Drugs

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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 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
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
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
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