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 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 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 2 of 2 · 72 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 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…2024-02-18 07:12 UTC 2024-02 N214622-001 TRUSELTIQ 25MG CAPSULE / ORAL RLD 2021-05-28 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N214622-002 TRUSELTIQ 100MG CAPSULE / ORAL RLD 2021-05-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N214622-001 TRUSELTIQ 25MG CAPSULE / ORAL RLD 2021-05-28 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N214622-002 TRUSELTIQ 100MG CAPSULE / ORAL RLD 2021-05-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N214622-001 TRUSELTIQ 25MG CAPSULE / ORAL RLD 2021-05-28 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N214622-002 TRUSELTIQ 100MG CAPSULE / ORAL RLD 2021-05-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N214622-001 TRUSELTIQ 25MG CAPSULE / ORAL RLD 2021-05-28 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N214622-002 TRUSELTIQ 100MG CAPSULE / ORAL RLD 2021-05-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N214622-001 TRUSELTIQ 25MG CAPSULE / ORAL RLD 2021-05-28 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N214622-002 TRUSELTIQ 100MG CAPSULE / ORAL RLD 2021-05-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N214622-001 TRUSELTIQ 25MG CAPSULE / ORAL RLD 2021-05-28 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N214622-002 TRUSELTIQ 100MG CAPSULE / ORAL RLD 2021-05-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N214622-001 TRUSELTIQ 25MG CAPSULE / ORAL RLD 2021-05-28 053a50430f4f…2023-05-13 08:27 UTC 2023-05 N214622-002 TRUSELTIQ 100MG CAPSULE / ORAL RLD, RS 2021-05-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N214622-001 TRUSELTIQ 25MG CAPSULE / ORAL RLD 2021-05-28 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 N214622-002 TRUSELTIQ 100MG CAPSULE / ORAL RLD, RS 2021-05-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N214622-001 TRUSELTIQ 25MG CAPSULE / ORAL RLD 2021-05-28 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N214622-002 TRUSELTIQ 100MG CAPSULE / ORAL RLD, RS 2021-05-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N214622-001 TRUSELTIQ 25MG CAPSULE / ORAL RLD 2021-05-28 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N214622-002 TRUSELTIQ 100MG CAPSULE / ORAL RLD, RS 2021-05-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N214622-001 TRUSELTIQ 25MG CAPSULE / ORAL RLD 2021-05-28 e64feba35796…2022-09-29 23:25 UTC 2022-09 N214622-002 TRUSELTIQ 100MG CAPSULE / ORAL RLD, RS 2021-05-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N214622-001 TRUSELTIQ 25MG CAPSULE / ORAL RLD 2021-05-28 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N214622-002 TRUSELTIQ 100MG CAPSULE / ORAL RLD, RS 2021-05-28 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N214622-001 TRUSELTIQ 25MG CAPSULE / ORAL RLD 2021-05-28 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N214622-002 TRUSELTIQ 100MG CAPSULE / ORAL RLD 2021-05-28 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 8 · 288 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N214622-001 9067896 2028-08-06 Drug substance 2021-06-08 c2088c7a36db…2026-10-15 13:18:30 2026-09 N214622-001 8552002 2029-08-25 Drug substance, Drug product 2021-06-08 c2088c7a36db…2026-10-15 13:18:30 2026-09 N214622-001 10278969 2034-12-11 Drug product 2021-06-08 c2088c7a36db…2026-10-15 13:18:30 2026-09 N214622-001 11160804 2034-12-11 Drug product 2021-12-01 c2088c7a36db…2026-10-15 13:18:30 2026-09 N214622-002 9067896 2028-08-06 Drug substance 2021-06-08 c2088c7a36db…2026-10-15 13:18:30 2026-09 N214622-002 8552002 2029-08-25 Drug substance, Drug product 2021-06-08 c2088c7a36db…2026-10-15 13:18:30 2026-09 N214622-002 10278969 2034-12-11 Drug product 2021-06-08 c2088c7a36db…2026-10-15 13:18:30 2026-09 N214622-002 11160804 2034-12-11 Drug product 2021-12-01 c2088c7a36db…2026-09-14 22:38:34 2026-08 N214622-001 9067896 2028-08-06 Drug substance 2021-06-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214622-001 8552002 2029-08-25 Drug substance, Drug product 2021-06-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214622-001 10278969 2034-12-11 Drug product 2021-06-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214622-001 11160804 2034-12-11 Drug product 2021-12-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214622-002 9067896 2028-08-06 Drug substance 2021-06-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214622-002 8552002 2029-08-25 Drug substance, Drug product 2021-06-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214622-002 10278969 2034-12-11 Drug product 2021-06-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214622-002 11160804 2034-12-11 Drug product 2021-12-01 84e616aacf4f…2026-08-18 06:07:40 2026-07 N214622-001 9067896 2028-08-06 Drug substance 2021-06-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214622-001 8552002 2029-08-25 Drug substance, Drug product 2021-06-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214622-001 10278969 2034-12-11 Drug product 2021-06-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214622-001 11160804 2034-12-11 Drug product 2021-12-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214622-002 9067896 2028-08-06 Drug substance 2021-06-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214622-002 8552002 2029-08-25 Drug substance, Drug product 2021-06-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214622-002 10278969 2034-12-11 Drug product 2021-06-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214622-002 11160804 2034-12-11 Drug product 2021-12-01 caaa826d4ba7…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…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 4 · 144 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 · 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