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 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 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 · 80 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 2026-10-15 13:18:30 2026-09 N213411-001 TUKYSA 50MG TABLET / ORAL RLD 2020-04-17 c2088c7a36db…2026-10-15 13:18:30 2026-09 N213411-002 TUKYSA 150MG TABLET / ORAL RLD, RS 2020-04-17 c2088c7a36db…2026-09-14 22:38:34 2026-08 N213411-001 TUKYSA 50MG TABLET / ORAL RLD 2020-04-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213411-002 TUKYSA 150MG TABLET / ORAL RLD, RS 2020-04-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 N213411-001 TUKYSA 50MG TABLET / ORAL RLD 2020-04-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213411-002 TUKYSA 150MG TABLET / ORAL RLD, RS 2020-04-17 caaa826d4ba7…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…
Observed Orange Book patent history# Patent history page 2 of 13 · 484 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N213411-002 11666572 2038-04-27 U-3783 2024-01-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213411-002 12048698 2038-04-27 U-3783 2024-08-28 caaa826d4ba7…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…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 7 · 254 observed states.
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 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