Home Applications 207981 Application 207981
Type NDA
Sponsor TAIHO ONCOLOGY Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LONSURF TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE TABLET;ORAL EQ 6.14MG BASE;15MG Yes No 002 LONSURF TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE TABLET;ORAL EQ 8.19MG BASE;20MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 N207981-001 LONSURF TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE EQ 6.14MG BASE;15MG TABLET / ORAL AB RLD 2015-09-22 N207981-002 LONSURF TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE EQ 8.19MG BASE;20MG TABLET / ORAL AB RLD, RS 2015-09-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 20 matching rows.
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N207981-001 ODE-229 2026-02-22 N207981-002 ODE-229 2026-02-22
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.
Product history page 1 of 3 · 86 observed 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 2026-09-14 22:38:34 2026-08 N207981-001 LONSURF EQ 6.14MG BASE;15MG TABLET / ORAL AB RLD 2015-09-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207981-002 LONSURF EQ 8.19MG BASE;20MG TABLET / ORAL AB RLD, RS 2015-09-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 N207981-001 LONSURF EQ 6.14MG BASE;15MG TABLET / ORAL AB RLD 2015-09-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207981-002 LONSURF EQ 8.19MG BASE;20MG TABLET / ORAL AB RLD, RS 2015-09-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N207981-001 LONSURF EQ 6.14MG BASE;15MG TABLET / ORAL AB RLD 2015-09-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N207981-002 LONSURF EQ 8.19MG BASE;20MG TABLET / ORAL AB RLD, RS 2015-09-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207981-001 LONSURF EQ 6.14MG BASE;15MG TABLET / ORAL AB RLD 2015-09-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N207981-002 LONSURF EQ 8.19MG BASE;20MG TABLET / ORAL AB RLD, RS 2015-09-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N207981-001 LONSURF EQ 6.14MG BASE;15MG TABLET / ORAL AB RLD 2015-09-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N207981-002 LONSURF EQ 8.19MG BASE;20MG TABLET / ORAL AB RLD, RS 2015-09-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207981-001 LONSURF EQ 6.14MG BASE;15MG TABLET / ORAL AB RLD 2015-09-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N207981-002 LONSURF EQ 8.19MG BASE;20MG TABLET / ORAL AB RLD, RS 2015-09-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207981-001 LONSURF EQ 6.14MG BASE;15MG TABLET / ORAL AB RLD 2015-09-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N207981-002 LONSURF EQ 8.19MG BASE;20MG TABLET / ORAL AB RLD, RS 2015-09-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207981-001 LONSURF EQ 6.14MG BASE;15MG TABLET / ORAL AB RLD 2015-09-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N207981-002 LONSURF EQ 8.19MG BASE;20MG TABLET / ORAL AB RLD, RS 2015-09-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207981-001 LONSURF EQ 6.14MG BASE;15MG TABLET / ORAL AB RLD 2015-09-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N207981-002 LONSURF EQ 8.19MG BASE;20MG TABLET / ORAL AB RLD, RS 2015-09-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207981-001 LONSURF EQ 6.14MG BASE;15MG TABLET / ORAL AB RLD 2015-09-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N207981-002 LONSURF EQ 8.19MG BASE;20MG TABLET / ORAL AB RLD, RS 2015-09-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N207981-001 LONSURF EQ 6.14MG BASE;15MG TABLET / ORAL AB RLD 2015-09-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N207981-002 LONSURF EQ 8.19MG BASE;20MG TABLET / ORAL AB RLD, RS 2015-09-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N207981-001 LONSURF EQ 6.14MG BASE;15MG TABLET / ORAL AB RLD 2015-09-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N207981-002 LONSURF EQ 8.19MG BASE;20MG TABLET / ORAL AB RLD, RS 2015-09-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N207981-001 LONSURF EQ 6.14MG BASE;15MG TABLET / ORAL AB RLD 2015-09-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N207981-002 LONSURF EQ 8.19MG BASE;20MG TABLET / ORAL AB RLD, RS 2015-09-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N207981-001 LONSURF EQ 6.14MG BASE;15MG TABLET / ORAL AB RLD 2015-09-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N207981-002 LONSURF EQ 8.19MG BASE;20MG TABLET / ORAL AB RLD, RS 2015-09-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N207981-001 LONSURF EQ 6.14MG BASE;15MG TABLET / ORAL AB RLD 2015-09-22 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N207981-002 LONSURF EQ 8.19MG BASE;20MG TABLET / ORAL AB RLD, RS 2015-09-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N207981-001 LONSURF EQ 6.14MG BASE;15MG TABLET / ORAL AB RLD 2015-09-22 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N207981-002 LONSURF EQ 8.19MG BASE;20MG TABLET / ORAL AB RLD, RS 2015-09-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N207981-001 LONSURF EQ 6.14MG BASE;15MG TABLET / ORAL RLD 2015-09-22 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N207981-002 LONSURF EQ 8.19MG BASE;20MG TABLET / ORAL RLD, RS 2015-09-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N207981-001 LONSURF EQ 6.14MG BASE;15MG TABLET / ORAL RLD 2015-09-22 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N207981-002 LONSURF EQ 8.19MG BASE;20MG TABLET / ORAL RLD, RS 2015-09-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N207981-001 LONSURF EQ 6.14MG BASE;15MG TABLET / ORAL RLD 2015-09-22 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N207981-002 LONSURF EQ 8.19MG BASE;20MG TABLET / ORAL RLD, RS 2015-09-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N207981-001 LONSURF EQ 6.14MG BASE;15MG TABLET / ORAL RLD 2015-09-22 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N207981-002 LONSURF EQ 8.19MG BASE;20MG TABLET / ORAL RLD, RS 2015-09-22 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 46 observed states.
Observed Orange Book patent history# Patent history page 1 of 17 · 680 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N207981-001 RE46284 2029-09-22 U-2503 2017-02-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207981-001 RE46284 2029-09-22 U-1751 2017-02-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207981-001 RE46284 2029-09-22 U-3656 2017-02-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207981-001 10457666 2034-06-17 Drug substance, Drug product 2019-11-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207981-001 9527833 2034-06-17 Drug substance, Drug product 2017-01-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207981-001 9943537 2034-09-05 U-3659 2023-08-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207981-001 10456399 2037-02-03 U-3657 2019-11-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207981-001 10456399 2037-02-03 U-3658 2019-11-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207981-001 10960004 2037-02-03 U-3657 2021-04-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207981-001 10960004 2037-02-03 U-3658 2021-04-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207981-002 RE46284 2029-09-22 U-1751 2017-02-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207981-002 RE46284 2029-09-22 U-2503 2017-02-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207981-002 RE46284 2029-09-22 U-3656 2017-02-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207981-002 10457666 2034-06-17 Drug substance, Drug product 2019-11-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207981-002 9527833 2034-06-17 Drug substance, Drug product 2017-01-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207981-002 9943537 2034-09-05 U-3659 2023-08-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207981-002 10456399 2037-02-03 U-3658 2019-11-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207981-002 10456399 2037-02-03 U-3657 2019-11-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207981-002 10960004 2037-02-03 U-3657 2021-04-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N207981-002 10960004 2037-02-03 U-3658 2021-04-09 84e616aacf4f…2026-08-18 06:07:40 2026-07 N207981-001 RE46284 2029-09-22 U-2503 2017-02-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207981-001 RE46284 2029-09-22 U-1751 2017-02-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207981-001 RE46284 2029-09-22 U-3656 2017-02-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207981-001 10457666 2034-06-17 Drug substance, Drug product 2019-11-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207981-001 9527833 2034-06-17 Drug substance, Drug product 2017-01-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207981-001 9943537 2034-09-05 U-3659 2023-08-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207981-001 10456399 2037-02-03 U-3657 2019-11-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207981-001 10456399 2037-02-03 U-3658 2019-11-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207981-001 10960004 2037-02-03 U-3657 2021-04-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207981-001 10960004 2037-02-03 U-3658 2021-04-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207981-002 RE46284 2029-09-22 U-1751 2017-02-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207981-002 RE46284 2029-09-22 U-2503 2017-02-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207981-002 RE46284 2029-09-22 U-3656 2017-02-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207981-002 10457666 2034-06-17 Drug substance, Drug product 2019-11-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207981-002 9527833 2034-06-17 Drug substance, Drug product 2017-01-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207981-002 9943537 2034-09-05 U-3659 2023-08-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207981-002 10456399 2037-02-03 U-3658 2019-11-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207981-002 10456399 2037-02-03 U-3657 2019-11-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207981-002 10960004 2037-02-03 U-3657 2021-04-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N207981-002 10960004 2037-02-03 U-3658 2021-04-09 caaa826d4ba7…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 4 · 134 observed states.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 64842-1020 LONSURF trifluridine and tipiracil Taiho Pharmaceutical Co., Ltd. NDA Current 64842-1020 LONSURF trifluridine and tipiracil Taiho Pharmaceutical Co., Ltd. NDA Current 64842-1020 LONSURF trifluridine and tipiracil Taiho Pharmaceutical Co., Ltd. NDA Current 64842-1025 LONSURF trifluridine and tipiracil Taiho Pharmaceutical Co., Ltd. NDA Current 64842-1025 LONSURF trifluridine and tipiracil Taiho Pharmaceutical Co., Ltd. NDA Current 64842-1025 LONSURF trifluridine and tipiracil Taiho Pharmaceutical Co., Ltd. NDA Current