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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 210498
Company: ARRAY BIOPHARMA INC

Medication Guide

Products on NDA 210498

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MEKTOVI	BINIMETINIB	15MG	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 210498

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/2018/210498lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/210498Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210498Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/12/2024	SUPPL-10	Efficacy-Labeling Change With Clinical Data, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210498s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/210498Orig1s010ltr.pdf
10/11/2023	SUPPL-9	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210498s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/210498Orig1s009ltr.pdf
01/23/2019	SUPPL-1	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210498s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210498Orig1s001ltr.pdf

Labels for NDA 210498

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/12/2024	SUPPL-10	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210498s010lbl.pdf
09/12/2024	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210498s010lbl.pdf
10/11/2023	SUPPL-9	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210498s009lbl.pdf
01/23/2019	SUPPL-1	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210498s001lbl.pdf
06/27/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210498lbl.pdf

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