U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 214036
Company: INTAS PHARMS LTD

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRIFLURIDINE; TIPIRACIL TRIFLURIDINE; TIPIRACIL 15MG/6.14MG TABLET;ORAL None (Tentative Approval) None No No
TRIFLURIDINE; TIPIRACIL TRIFLURIDINE; TIPIRACIL 20MG/8.19MG TABLET;ORAL None (Tentative Approval) None No No

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/13/2022 ORIG-1 Tentative Approval STANDARD Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/214036Orig1s000TAltr.pdf
Back to Top