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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 211810
Company: DAIICHI SANKYO INC

Medication Guide

REMS

Products on NDA 211810

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TURALIO	PEXIDARTINIB HYDROCHLORIDE	EQ 200MG BASE	CAPSULE;ORAL	Discontinued	None	Yes	No
TURALIO	PEXIDARTINIB HYDROCHLORIDE	EQ 125MG BASE	CAPSULE;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 211810

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/02/2019	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211810s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/211810Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211810Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/27/2025	SUPPL-14	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/211810Orig1s014ltr.pdf
01/03/2025	SUPPL-13	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/211810s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/211810Orig1s013ltr.pdf
11/16/2023	SUPPL-12	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211810s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/211810Orig1s012ltr.pdf
04/17/2023	SUPPL-11	REMS - MODIFIED - D-N-A		Label is not available on this site.
07/14/2022	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211810s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/211810Orig1s010ltr.pdf
10/14/2022	SUPPL-9	Efficacy-New Dosing Regimen, Labeling-Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211810s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/211810Orig1s009ltr.pdf
10/06/2022	SUPPL-8	Efficacy-Labeling Change With Clinical Data, Labeling-Medication Guide, Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/211810Orig1s008ltr.pdf
10/20/2021	SUPPL-7	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211810s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/211810Orig1s007ltr.pdf
12/16/2020	SUPPL-6	REMS - MODIFIED - D-N-A	Letter (PDF) Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/211810Orig1s006ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/211810Orig1s006ltr.pdf
08/04/2020	SUPPL-5	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/211810Orig1s005ltr.pdf
04/10/2020	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
04/17/2020	SUPPL-3	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211810s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/211810Orig1s003ltr.pdf
11/19/2019	SUPPL-2	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/211810Orig1s001,s002ltr.pdf
11/19/2019	SUPPL-1	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/211810Orig1s001,s002ltr.pdf

Labels for NDA 211810

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/03/2025	SUPPL-13	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/211810s013lbl.pdf
01/03/2025	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/211810s013lbl.pdf
11/16/2023	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211810s012lbl.pdf
11/16/2023	SUPPL-12	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211810s012lbl.pdf
10/14/2022	SUPPL-9	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211810s009lbl.pdf
10/14/2022	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211810s009lbl.pdf
10/14/2022	SUPPL-9	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211810s009lbl.pdf
07/14/2022	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211810s010lbl.pdf
10/20/2021	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211810s007lbl.pdf
10/20/2021	SUPPL-7	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211810s007lbl.pdf
04/17/2020	SUPPL-3	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211810s003lbl.pdf
04/17/2020	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211810s003lbl.pdf
08/02/2019	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211810s000lbl.pdf

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