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 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
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
04/10/2020 SUPPL-4 Labeling-Package Insert

Label is not available on this site.
04/17/2020 SUPPL-3 Labeling-Package Insert, Labeling-Medication Guide 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
04/17/2020 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211810s003lbl.pdf
04/17/2020 SUPPL-3 Labeling-Medication Guide 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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