← FDA DRUG APPROVALS

FDA NDA · NDA207981

LONSURF

trifluridine and tipiracil

Sponsor: TAIHO ONCOLOGY

APPLICATION
NDA207981
TYPE
NDA
ORIGINAL APPROVAL
2015-09-22
LATEST ACTION
2023-08-02
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

LONSURF · ReferencePrescription
TIPIRACIL HYDROCHLORIDE EQ 6.14MG BASE, TRIFLURIDINE 15MG · TABLET · ORAL
LONSURF · ReferencePrescription
TIPIRACIL HYDROCHLORIDE EQ 8.19MG BASE, TRIFLURIDINE 20MG · TABLET · ORAL

Approval history

2023-08-02Efficacy · Supplement 12 · priority — Label ↗AP
2020-01-01Labeling · Supplement 9 · standard — Letter ↗AP
2019-02-22Efficacy · Supplement 8 · priority — Label ↗AP
2017-06-29Labeling · Supplement 6 · standard — Label ↗AP
2017-03-30Labeling · Supplement 4 · standard — Label ↗AP
2016-04-05Manufacturing (CMC) · Supplement 3 · standardAP
2015-11-20Manufacturing (CMC) · Supplement 2 · standardAP
2015-11-13Manufacturing (CMC) · Supplement 1 · standardAP
2015-09-22Type 1 - New Molecular Entity and Type 4 - New Combination · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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