Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 214008
Company: NATCO

Products on ANDA 214008

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TIPIRACIL HYDROCHLORIDE AND TRIFLURIDINE	TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE	EQ 6.14MG BASE;15MG	TABLET;ORAL	Prescription	AB	No	No
TIPIRACIL HYDROCHLORIDE AND TRIFLURIDINE	TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE	EQ 8.19MG BASE;20MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 214008

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/13/2023	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/214008Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 214008

TIPIRACIL HYDROCHLORIDE AND TRIFLURIDINE

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