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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 211810
Company: DAIICHI SANKYO INC
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 No
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
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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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