Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 207981
Company: TAIHO ONCOLOGY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LONSURF TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE EQ 6.14MG BASE;15MG TABLET;ORAL Prescription None Yes No
LONSURF TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE EQ 8.19MG BASE;20MG TABLET;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
09/22/2015 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207981s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207981Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207981Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207981Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/29/2017 SUPPL-6 Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207981s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207981Orig1s006ltr.pdf
03/30/2017 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207981s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207981Orig1s004ltr.pdf
04/05/2016 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

11/20/2015 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

11/13/2015 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/29/2017 SUPPL-6 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207981s006lbl.pdf
03/30/2017 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207981s004lbl.pdf
09/22/2015 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207981s000lbl.pdf

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