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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 210496
Company: ARRAY BIOPHARMA INC

Medication Guide

Products on NDA 210496

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 210496

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
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

Labels for NDA 210496

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
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

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