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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 207981
Company: TAIHO ONCOLOGY

Summary Review

Products on NDA 207981

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	AB	Yes	No
LONSURF	TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE	EQ 8.19MG BASE;20MG	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 207981

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 and Type 4 - New Combination	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
08/02/2023	SUPPL-12	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/207981s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/207981Orig1s012ltr.pdf
01/01/2020	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207981s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/207981Orig1s009ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/207981Orig1s009.pdf
02/22/2019	SUPPL-8	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207981s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/207981Orig1s008ltr.pdf
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.

Labels for NDA 207981

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/02/2023	SUPPL-12	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/207981s012lbl.pdf
01/01/2020	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207981s009lbl.pdf
02/22/2019	SUPPL-8	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207981s008lbl.pdf
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

Therapeutic Equivalents for NDA 207981

LONSURF

TABLET;ORAL; EQ 6.14MG BASE;15MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LONSURF	TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE	EQ 6.14MG BASE;15MG	TABLET;ORAL	Prescription	Yes	AB	207981	TAIHO ONCOLOGY
TIPIRACIL HYDROCHLORIDE AND TRIFLURIDINE	TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE	EQ 6.14MG BASE;15MG	TABLET;ORAL	Prescription	No	AB	214008	NATCO

TABLET;ORAL; EQ 8.19MG BASE;20MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LONSURF	TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE	EQ 8.19MG BASE;20MG	TABLET;ORAL	Prescription	Yes	AB	207981	TAIHO ONCOLOGY
TIPIRACIL HYDROCHLORIDE AND TRIFLURIDINE	TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE	EQ 8.19MG BASE;20MG	TABLET;ORAL	Prescription	No	AB	214008	NATCO

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