Application 214008

Type: ANDA
Sponsor: NATCO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TIPIRACIL HYDROCHLORIDE AND TRIFLURIDINE	TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE	TABLET;ORAL	EQ 6.14MG BASE;15MG	No	No
002	TIPIRACIL HYDROCHLORIDE AND TRIFLURIDINE	TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE	TABLET;ORAL	EQ 8.19MG BASE;20MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A214008-001	TIPIRACIL HYDROCHLORIDE AND TRIFLURIDINE	TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE	EQ 6.14MG BASE;15MG	TABLET / ORAL	AB		2023-06-13
A214008-002	TIPIRACIL HYDROCHLORIDE AND TRIFLURIDINE	TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE	EQ 8.19MG BASE;20MG	TABLET / ORAL	AB		2023-06-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A214008-001	AB
A214008-002	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A214008-001	TIPIRACIL HYDROCHLORIDE AND TRIFLURIDINE	EQ 6.14MG BASE;15MG	TABLET / ORAL	AB		2023-06-13	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A214008-002	TIPIRACIL HYDROCHLORIDE AND TRIFLURIDINE	EQ 8.19MG BASE;20MG	TABLET / ORAL	AB		2023-06-13	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A214008-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A214008-002	AB	1	`a50c72e98297…`

Documents#

Document, Submission type, Date table
Document	Submission type	Date
74735	ORIG	2023-07-13