Home Applications 214622 Application 214622
Type NDA
Sponsor QED THERAPEUTICS INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TRUSELTIQ INFIGRATINIB CAPSULE;ORAL 25MG Yes No 002 TRUSELTIQ INFIGRATINIB CAPSULE;ORAL 100MG Yes 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 N214622-001 TRUSELTIQ INFIGRATINIB PHOSPHATE 25MG CAPSULE / ORAL RLD 2021-05-28 N214622-002 TRUSELTIQ INFIGRATINIB PHOSPHATE 100MG CAPSULE / ORAL RLD 2021-05-28
Orange Book patents# Current patent rows page 1 of 1 · 8 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N214622-001 9067896 2028-08-06 Drug substance 2021-06-08 N214622-001 8552002 2029-08-25 Drug substance, Drug product 2021-06-08 N214622-001 10278969 2034-12-11 Drug product 2021-06-08 N214622-001 11160804 2034-12-11 Drug product 2021-12-01 N214622-002 9067896 2028-08-06 Drug substance 2021-06-08 N214622-002 8552002 2029-08-25 Drug substance, Drug product 2021-06-08 N214622-002 10278969 2034-12-11 Drug product 2021-06-08 N214622-002 11160804 2034-12-11 Drug product 2021-12-01
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.
Product history page 1 of 2 · 66 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 N214622-001 TRUSELTIQ 25MG CAPSULE / ORAL RLD 2021-05-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214622-002 TRUSELTIQ 100MG CAPSULE / ORAL RLD 2021-05-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214622-001 TRUSELTIQ 25MG CAPSULE / ORAL RLD 2021-05-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214622-002 TRUSELTIQ 100MG CAPSULE / ORAL RLD 2021-05-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214622-001 TRUSELTIQ 25MG CAPSULE / ORAL RLD 2021-05-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214622-002 TRUSELTIQ 100MG CAPSULE / ORAL RLD 2021-05-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214622-001 TRUSELTIQ 25MG CAPSULE / ORAL RLD 2021-05-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214622-002 TRUSELTIQ 100MG CAPSULE / ORAL RLD 2021-05-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214622-001 TRUSELTIQ 25MG CAPSULE / ORAL RLD 2021-05-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214622-002 TRUSELTIQ 100MG CAPSULE / ORAL RLD 2021-05-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214622-001 TRUSELTIQ 25MG CAPSULE / ORAL RLD 2021-05-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214622-002 TRUSELTIQ 100MG CAPSULE / ORAL RLD 2021-05-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214622-001 TRUSELTIQ 25MG CAPSULE / ORAL RLD 2021-05-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214622-002 TRUSELTIQ 100MG CAPSULE / ORAL RLD 2021-05-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214622-001 TRUSELTIQ 25MG CAPSULE / ORAL RLD 2021-05-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214622-002 TRUSELTIQ 100MG CAPSULE / ORAL RLD 2021-05-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214622-001 TRUSELTIQ 25MG CAPSULE / ORAL RLD 2021-05-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214622-002 TRUSELTIQ 100MG CAPSULE / ORAL RLD 2021-05-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N214622-001 TRUSELTIQ 25MG CAPSULE / ORAL RLD 2021-05-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N214622-002 TRUSELTIQ 100MG CAPSULE / ORAL RLD 2021-05-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214622-001 TRUSELTIQ 25MG CAPSULE / ORAL RLD 2021-05-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214622-002 TRUSELTIQ 100MG CAPSULE / ORAL RLD 2021-05-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214622-001 TRUSELTIQ 25MG CAPSULE / ORAL RLD 2021-05-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214622-002 TRUSELTIQ 100MG CAPSULE / ORAL RLD 2021-05-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N214622-001 TRUSELTIQ 25MG CAPSULE / ORAL RLD 2021-05-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N214622-002 TRUSELTIQ 100MG CAPSULE / ORAL RLD 2021-05-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N214622-001 TRUSELTIQ 25MG CAPSULE / ORAL RLD 2021-05-28 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N214622-002 TRUSELTIQ 100MG CAPSULE / ORAL RLD 2021-05-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N214622-001 TRUSELTIQ 25MG CAPSULE / ORAL RLD 2021-05-28 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N214622-002 TRUSELTIQ 100MG CAPSULE / ORAL RLD, RS 2021-05-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N214622-001 TRUSELTIQ 25MG CAPSULE / ORAL RLD 2021-05-28 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N214622-002 TRUSELTIQ 100MG CAPSULE / ORAL RLD, RS 2021-05-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N214622-001 TRUSELTIQ 25MG CAPSULE / ORAL RLD 2021-05-28 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N214622-002 TRUSELTIQ 100MG CAPSULE / ORAL RLD, RS 2021-05-28 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N214622-001 TRUSELTIQ 25MG CAPSULE / ORAL RLD 2021-05-28 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N214622-002 TRUSELTIQ 100MG CAPSULE / ORAL RLD, RS 2021-05-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N214622-001 TRUSELTIQ 25MG CAPSULE / ORAL RLD 2021-05-28 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N214622-002 TRUSELTIQ 100MG CAPSULE / ORAL RLD, RS 2021-05-28 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N214622-001 TRUSELTIQ 25MG CAPSULE / ORAL RLD 2021-05-28 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N214622-002 TRUSELTIQ 100MG CAPSULE / ORAL RLD 2021-05-28 6a51e52b5d6a…
Observed Orange Book patent history# Patent history page 1 of 7 · 264 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 N214622-001 9067896 2028-08-06 Drug substance 2021-06-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214622-001 8552002 2029-08-25 Drug substance, Drug product 2021-06-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214622-001 10278969 2034-12-11 Drug product 2021-06-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214622-001 11160804 2034-12-11 Drug product 2021-12-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214622-002 9067896 2028-08-06 Drug substance 2021-06-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214622-002 8552002 2029-08-25 Drug substance, Drug product 2021-06-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214622-002 10278969 2034-12-11 Drug product 2021-06-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214622-002 11160804 2034-12-11 Drug product 2021-12-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214622-001 9067896 2028-08-06 Drug substance 2021-06-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214622-001 8552002 2029-08-25 Drug substance, Drug product 2021-06-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214622-001 10278969 2034-12-11 Drug product 2021-06-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214622-001 11160804 2034-12-11 Drug product 2021-12-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214622-002 9067896 2028-08-06 Drug substance 2021-06-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214622-002 8552002 2029-08-25 Drug substance, Drug product 2021-06-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214622-002 10278969 2034-12-11 Drug product 2021-06-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214622-002 11160804 2034-12-11 Drug product 2021-12-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214622-001 9067896 2028-08-06 Drug substance 2021-06-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214622-001 8552002 2029-08-25 Drug substance, Drug product 2021-06-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214622-001 10278969 2034-12-11 Drug product 2021-06-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214622-001 11160804 2034-12-11 Drug product 2021-12-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214622-002 9067896 2028-08-06 Drug substance 2021-06-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214622-002 8552002 2029-08-25 Drug substance, Drug product 2021-06-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214622-002 10278969 2034-12-11 Drug product 2021-06-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214622-002 11160804 2034-12-11 Drug product 2021-12-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214622-001 9067896 2028-08-06 Drug substance 2021-06-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214622-001 8552002 2029-08-25 Drug substance, Drug product 2021-06-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214622-001 10278969 2034-12-11 Drug product 2021-06-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214622-001 11160804 2034-12-11 Drug product 2021-12-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214622-002 9067896 2028-08-06 Drug substance 2021-06-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214622-002 8552002 2029-08-25 Drug substance, Drug product 2021-06-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214622-002 10278969 2034-12-11 Drug product 2021-06-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214622-002 11160804 2034-12-11 Drug product 2021-12-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214622-001 9067896 2028-08-06 Drug substance 2021-06-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214622-001 8552002 2029-08-25 Drug substance, Drug product 2021-06-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214622-001 10278969 2034-12-11 Drug product 2021-06-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214622-001 11160804 2034-12-11 Drug product 2021-12-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214622-002 9067896 2028-08-06 Drug substance 2021-06-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214622-002 8552002 2029-08-25 Drug substance, Drug product 2021-06-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214622-002 10278969 2034-12-11 Drug product 2021-06-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214622-002 11160804 2034-12-11 Drug product 2021-12-01 b8a1b40f171c…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 4 · 132 observed states.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 12 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 72730-101 TRUSELTIQ infigratinib QED Therapeutics, Inc. NDA Current 72730-101 TRUSELTIQ infigratinib QED Therapeutics, Inc. NDA Current 72730-101 TRUSELTIQ infigratinib QED Therapeutics, Inc. NDA Current 72730-111 TRUSELTIQ infigratinib QED Therapeutics, Inc. NDA Current 72730-111 TRUSELTIQ infigratinib QED Therapeutics, Inc. NDA Current 72730-111 TRUSELTIQ infigratinib QED Therapeutics, Inc. NDA Current 72730-202 TRUSELTIQ infigratinib QED Therapeutics, Inc. NDA Current 72730-202 TRUSELTIQ infigratinib QED Therapeutics, Inc. NDA Current 72730-202 TRUSELTIQ infigratinib QED Therapeutics, Inc. NDA Current 72730-506 TRUSELTIQ infigratinib QED Therapeutics, Inc. NDA Current 72730-506 TRUSELTIQ infigratinib QED Therapeutics, Inc. NDA Current 72730-506 TRUSELTIQ infigratinib QED Therapeutics, Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 67905 ORIG 2021-06-25 67635 ORIG 2021-06-01 67630 ORIG 2021-05-28