Home Applications 213411 Application 213411
Type NDA
Sponsor SEATTLE GENETICS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TUKYSA TUCATINIB TABLET;ORAL 50MG Yes No 002 TUKYSA TUCATINIB TABLET;ORAL 150MG Yes Yes
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 N213411-001 TUKYSA TUCATINIB 50MG TABLET / ORAL RLD 2020-04-17 N213411-002 TUKYSA TUCATINIB 150MG TABLET / ORAL RLD, RS 2020-04-17
Orange Book patents# Current patent rows page 1 of 1 · 14 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N213411-001 9693989 2027-05-09 U-2788 Drug product 2020-04-29 N213411-001 9457093 2032-10-12 U-2788 Drug product 2020-04-29 N213411-001 11504370 2033-03-25 U-2788 2022-12-05 N213411-001 8648087 2034-04-17 Drug substance, Drug product 2020-04-29 N213411-001 11207324 2038-04-27 U-3783 2023-02-02 N213411-001 11666572 2038-04-27 U-3783 2024-01-29 N213411-001 12048698 2038-04-27 U-3783 2024-08-28 N213411-002 9693989 2027-05-09 U-2788 Drug product 2020-04-29 N213411-002 9457093 2032-10-12 U-2788 Drug product 2020-04-29 N213411-002 11504370 2033-03-25 U-2788 2022-12-05 N213411-002 8648087 2034-04-17 Drug substance, Drug product 2020-04-29 N213411-002 11207324 2038-04-27 U-3783 2023-02-02 N213411-002 11666572 2038-04-27 U-3783 2024-01-29 N213411-002 12048698 2038-04-27 U-3783 2024-08-28
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 6 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.
Product history page 1 of 2 · 74 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 2026-02-19 14:30 UTC 2026-02 N213411-001 TUKYSA 50MG TABLET / ORAL RLD 2020-04-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213411-002 TUKYSA 150MG TABLET / ORAL RLD, RS 2020-04-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213411-001 TUKYSA 50MG TABLET / ORAL RLD 2020-04-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213411-002 TUKYSA 150MG TABLET / ORAL RLD, RS 2020-04-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213411-001 TUKYSA 50MG TABLET / ORAL RLD 2020-04-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213411-002 TUKYSA 150MG TABLET / ORAL RLD, RS 2020-04-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213411-001 TUKYSA 50MG TABLET / ORAL RLD 2020-04-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213411-002 TUKYSA 150MG TABLET / ORAL RLD, RS 2020-04-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213411-001 TUKYSA 50MG TABLET / ORAL RLD 2020-04-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213411-002 TUKYSA 150MG TABLET / ORAL RLD, RS 2020-04-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213411-001 TUKYSA 50MG TABLET / ORAL RLD 2020-04-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213411-002 TUKYSA 150MG TABLET / ORAL RLD, RS 2020-04-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213411-001 TUKYSA 50MG TABLET / ORAL RLD 2020-04-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213411-002 TUKYSA 150MG TABLET / ORAL RLD, RS 2020-04-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213411-001 TUKYSA 50MG TABLET / ORAL RLD 2020-04-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213411-002 TUKYSA 150MG TABLET / ORAL RLD, RS 2020-04-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213411-001 TUKYSA 50MG TABLET / ORAL RLD 2020-04-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213411-002 TUKYSA 150MG TABLET / ORAL RLD, RS 2020-04-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N213411-001 TUKYSA 50MG TABLET / ORAL RLD 2020-04-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N213411-002 TUKYSA 150MG TABLET / ORAL RLD, RS 2020-04-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213411-001 TUKYSA 50MG TABLET / ORAL RLD 2020-04-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213411-002 TUKYSA 150MG TABLET / ORAL RLD, RS 2020-04-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213411-001 TUKYSA 50MG TABLET / ORAL RLD 2020-04-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213411-002 TUKYSA 150MG TABLET / ORAL RLD, RS 2020-04-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213411-001 TUKYSA 50MG TABLET / ORAL RLD 2020-04-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213411-002 TUKYSA 150MG TABLET / ORAL RLD, RS 2020-04-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N213411-001 TUKYSA 50MG TABLET / ORAL RLD 2020-04-17 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N213411-002 TUKYSA 150MG TABLET / ORAL RLD, RS 2020-04-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N213411-001 TUKYSA 50MG TABLET / ORAL RLD 2020-04-17 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N213411-002 TUKYSA 150MG TABLET / ORAL RLD, RS 2020-04-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N213411-001 TUKYSA 50MG TABLET / ORAL RLD 2020-04-17 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N213411-002 TUKYSA 150MG TABLET / ORAL RLD, RS 2020-04-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N213411-001 TUKYSA 50MG TABLET / ORAL RLD 2020-04-17 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N213411-002 TUKYSA 150MG TABLET / ORAL RLD, RS 2020-04-17 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N213411-001 TUKYSA 50MG TABLET / ORAL RLD 2020-04-17 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N213411-002 TUKYSA 150MG TABLET / ORAL RLD, RS 2020-04-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N213411-001 TUKYSA 50MG TABLET / ORAL RLD 2020-04-17 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N213411-002 TUKYSA 150MG TABLET / ORAL RLD, RS 2020-04-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N213411-001 TUKYSA 50MG TABLET / ORAL RLD 2020-04-17 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N213411-002 TUKYSA 150MG TABLET / ORAL RLD, RS 2020-04-17 87673890dc5c…
Observed Orange Book patent history# Patent history page 1 of 12 · 442 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N213411-001 9693989 2027-05-09 U-2788 Drug product 2020-04-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213411-001 8648087 2031-04-12 Drug substance, Drug product 2020-04-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213411-001 9457093 2032-10-12 U-2788 Drug product 2020-04-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213411-001 11504370 2033-03-25 U-2788 2022-12-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213411-001 11207324 2038-04-27 U-3783 2023-02-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213411-001 11666572 2038-04-27 U-3783 2024-01-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213411-001 12048698 2038-04-27 U-3783 2024-08-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213411-002 9693989 2027-05-09 U-2788 Drug product 2020-04-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213411-002 8648087 2031-04-12 Drug substance, Drug product 2020-04-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213411-002 9457093 2032-10-12 U-2788 Drug product 2020-04-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213411-002 11504370 2033-03-25 U-2788 2022-12-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213411-002 11207324 2038-04-27 U-3783 2023-02-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213411-002 11666572 2038-04-27 U-3783 2024-01-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213411-002 12048698 2038-04-27 U-3783 2024-08-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213411-001 7452895 2025-11-16 U-4153 Drug substance, Drug product 2020-04-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213411-001 7452895 2025-11-16 U-2788 Drug substance, Drug product 2020-04-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213411-001 9693989 2027-05-09 U-2788 Drug product 2020-04-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213411-001 8648087 2031-04-12 Drug substance, Drug product 2020-04-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213411-001 9457093 2032-10-12 U-2788 Drug product 2020-04-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213411-001 11504370 2033-03-25 U-2788 2022-12-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213411-001 11207324 2038-04-27 U-3783 2023-02-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213411-001 11666572 2038-04-27 U-3783 2024-01-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213411-001 12048698 2038-04-27 U-3783 2024-08-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213411-002 7452895 2025-11-16 U-4153 Drug substance, Drug product 2020-04-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213411-002 7452895 2025-11-16 U-2788 Drug substance, Drug product 2020-04-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213411-002 9693989 2027-05-09 U-2788 Drug product 2020-04-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213411-002 8648087 2031-04-12 Drug substance, Drug product 2020-04-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213411-002 9457093 2032-10-12 U-2788 Drug product 2020-04-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213411-002 11504370 2033-03-25 U-2788 2022-12-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213411-002 11207324 2038-04-27 U-3783 2023-02-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213411-002 11666572 2038-04-27 U-3783 2024-01-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213411-002 12048698 2038-04-27 U-3783 2024-08-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213411-001 7452895 2025-11-16 U-4153 Drug substance, Drug product 2020-04-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213411-001 7452895 2025-11-16 U-2788 Drug substance, Drug product 2020-04-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213411-001 9693989 2027-05-09 U-2788 Drug product 2020-04-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213411-001 8648087 2031-04-12 Drug substance, Drug product 2020-04-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213411-001 9457093 2032-10-12 U-2788 Drug product 2020-04-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213411-001 11504370 2033-03-25 U-2788 2022-12-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213411-001 11207324 2038-04-27 U-3783 2023-02-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213411-001 11666572 2038-04-27 U-3783 2024-01-29 6a471c1ec25d…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 6 · 236 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.
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 51144-001 TUKYSA tucatinib SEAGEN INC. NDA Current 51144-001 TUKYSA tucatinib SEAGEN INC. NDA Current 51144-001 TUKYSA tucatinib Seattle Genetics, Inc. NDA Current 51144-002 TUKYSA tucatinib SEAGEN INC. NDA Current 51144-002 TUKYSA tucatinib SEAGEN INC. NDA Current 51144-002 TUKYSA tucatinib Seattle Genetics, Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 73259 SUPPL 2023-01-20 73255 SUPPL 2023-01-20 63055 ORIG 2020-05-18 62594 ORIG 2020-04-20 62591 ORIG 2020-04-17