Home Applications 214801 Application 214801
Type NDA
Sponsor TAIHO ONCOLOGY Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LYTGOBI FUTIBATINIB TABLET, FILM COATED 4MG No No 002 LYTGOBI FUTIBATINIB TABLET;ORAL 16MG Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 N214801-001 LYTGOBI FUTIBATINIB 4MG TABLET / ORAL RLD, RS 2022-09-30 N214801-002 LYTGOBI FUTIBATINIB 16MG TABLET / ORAL RLD 2025-07-28
Orange Book patents# Current patent rows page 1 of 1 · 6 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N214801-001 9108973 2033-02-13 U-3456 Drug substance, Drug product 2022-10-24 N214801-001 10434103 2036-03-31 Drug substance, Drug product 2022-10-24 N214801-001 11833151 2039-11-05 Drug product 2024-01-03 N214801-002 9108973 2033-02-13 U-3456 Drug substance, Drug product 2025-09-11 N214801-002 10434103 2036-03-31 Drug substance, Drug product 2025-09-11 N214801-002 11833151 2039-11-05 Drug product 2025-09-11
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 4 matching rows.
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 2026-10-15 13:18:30 2026-09 N214801-001 LYTGOBI 4MG TABLET / ORAL RLD, RS 2022-09-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 N214801-002 LYTGOBI 16MG TABLET / ORAL RLD 2025-07-28 c2088c7a36db…2026-09-14 22:38:34 2026-08 N214801-001 LYTGOBI 4MG TABLET / ORAL RLD, RS 2022-09-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214801-002 LYTGOBI 16MG TABLET / ORAL RLD 2025-07-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 N214801-001 LYTGOBI 4MG TABLET / ORAL RLD, RS 2022-09-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214801-002 LYTGOBI 16MG TABLET / ORAL RLD 2025-07-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N214801-001 LYTGOBI 4MG TABLET / ORAL RLD, RS 2022-09-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214801-002 LYTGOBI 16MG TABLET / ORAL RLD 2025-07-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214801-001 LYTGOBI 4MG TABLET / ORAL RLD, RS 2022-09-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214801-002 LYTGOBI 16MG TABLET / ORAL RLD 2025-07-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214801-001 LYTGOBI 4MG TABLET / ORAL RLD, RS 2022-09-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214801-001 LYTGOBI 4MG TABLET / ORAL RLD, RS 2022-09-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214801-001 LYTGOBI 4MG TABLET / ORAL RLD, RS 2022-09-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214801-001 LYTGOBI 4MG TABLET / ORAL RLD, RS 2022-09-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214801-001 LYTGOBI 4MG TABLET / ORAL RLD, RS 2022-09-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214801-001 LYTGOBI 4MG TABLET / ORAL RLD, RS 2022-09-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214801-001 LYTGOBI 4MG TABLET / ORAL RLD, RS 2022-09-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N214801-001 LYTGOBI 4MG TABLET / ORAL RLD, RS 2022-09-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214801-001 LYTGOBI 4MG TABLET / ORAL RLD, RS 2022-09-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214801-001 LYTGOBI 4MG TABLET / ORAL RLD, RS 2022-09-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N214801-001 LYTGOBI 4MG TABLET / ORAL RLD, RS 2022-09-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N214801-001 LYTGOBI 4MG TABLET / ORAL RLD, RS 2022-09-30 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N214801-001 LYTGOBI 4MG TABLET / ORAL RLD, RS 2022-09-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N214801-001 LYTGOBI 4MG TABLET / ORAL RLD, RS 2022-09-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N214801-001 LYTGOBI 4MG TABLET / ORAL RLD, RS 2022-09-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N214801-001 LYTGOBI 4MG TABLET / ORAL RLD, RS 2022-09-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N214801-001 LYTGOBI 4MG TABLET / ORAL RLD, RS 2022-09-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N214801-001 LYTGOBI 4MG TABLET / ORAL RLD, RS 2022-09-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N214801-001 LYTGOBI 4MG TABLET / ORAL RLD, RS 2022-09-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N214801-001 LYTGOBI 4MG TABLET / ORAL RLD, RS 2022-09-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N214801-001 LYTGOBI 4MG TABLET / ORAL RLD, RS 2022-09-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N214801-001 LYTGOBI 4MG TABLET / ORAL RLD, RS 2022-09-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N214801-001 LYTGOBI 4MG TABLET / ORAL RLD, RS 2022-09-30 f41ea6bd6efb…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N214801-001 LYTGOBI 4MG TABLET / ORAL RLD, RS 2022-09-30 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N214801-002 LYTGOBI 16MG TABLET / ORAL RLD 2025-07-28 a50c72e98297…
Observed Orange Book patent history# Patent history page 3 of 3 · 94 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N214801-001 9108973 2033-02-23 U-3456 Drug substance, Drug product 2022-10-24 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N214801-001 10434103 2036-03-31 Drug substance, Drug product 2022-10-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N214801-001 9108973 2033-02-23 U-3456 Drug substance, Drug product 2022-10-24 053a50430f4f…2023-05-13 08:27 UTC 2023-05 N214801-001 10434103 2036-03-31 Drug substance, Drug product 2022-10-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N214801-001 9108973 2033-02-23 U-3456 Drug substance, Drug product 2022-10-24 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 N214801-001 10434103 2036-03-31 Drug substance, Drug product 2022-10-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N214801-001 9108973 2033-02-23 U-3456 Drug substance, Drug product 2022-10-24 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N214801-001 10434103 2036-03-31 Drug substance, Drug product 2022-10-24 3a93d1ddd44b…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N214801-001 9108973 2033-02-13 U-3456 Drug substance, Drug product 2022-10-24 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N214801-001 10434103 2036-03-31 Drug substance, Drug product 2022-10-24 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N214801-001 11833151 2039-11-05 Drug product 2024-01-03 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N214801-002 9108973 2033-02-13 U-3456 Drug substance, Drug product 2025-09-11 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N214801-002 10434103 2036-03-31 Drug substance, Drug product 2025-09-11 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N214801-002 11833151 2039-11-05 Drug product 2025-09-11 a50c72e98297…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 66 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join LYTGOBI FUTIBATINIB TAIHO PHARMACEUTICAL CO., LTD. 0b1332a1-0581-4707-9bf6-1eccfa39bef4 2025-10-27 Warnings, Adverse reactions Exact identifier application applno (NDA): 214801 application number: NDA214801
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents# Document, Submission type, Date table Document Submission type Date 83795 SUPPL 2025-10-16 83790 SUPPL 2025-10-16 78160 SUPPL 2024-04-19 78156 SUPPL 2024-04-18 72579 ORIG 2022-11-08 72256 ORIG 2022-10-05 72213 ORIG 2022-10-03