Drug application

LONSURF (TIPIRACIL HYDROCHLORIDE, TRIFLURIDINE)

Drugs@FDA NDA 207981 · TAIHO ONCOLOGY

Key facts

Drug name LONSURF
Active ingredients TIPIRACIL HYDROCHLORIDE, TRIFLURIDINE
Application type NDA
Application number 207981
Company TAIHO ONCOLOGY
Dosage forms TABLET, ORAL
Strength EQ 6.14MG BASE;15MG
Marketing status Prescription
TE codes AB
Reference listed drug Yes
Latest submission class Type 1 - New Molecular Entity and Type 4 - New Combination
Latest submission status date Sep 22, 2015

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • 1–9 Label versions
  • 1–9 Products
  • 1–9 Therapeutic equivalents
  • Yes FDA letters on file
  • Yes FDA reviews on file

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About Drugs@FDA applications

Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.

Source: U.S. Food and Drug Administration (FDA), Drugs@FDA · Source date:

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