Application 214622

Type
NDA
Sponsor
QED THERAPEUTICS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRUSELTIQINFIGRATINIBCAPSULE;ORAL25MGYesNo
002TRUSELTIQINFIGRATINIBCAPSULE;ORAL100MGYesNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N214622-001TRUSELTIQINFIGRATINIB PHOSPHATE25MGCAPSULE / ORALRLD2021-05-28
N214622-002TRUSELTIQINFIGRATINIB PHOSPHATE100MGCAPSULE / ORALRLD2021-05-28

Orange Book patents#

Current patent rows page 1 of 1 · 8 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N214622-00190678962028-08-06Drug substance2021-06-08
N214622-00185520022029-08-25Drug substance, Drug product2021-06-08
N214622-001102789692034-12-11Drug product2021-06-08
N214622-001111608042034-12-11Drug product2021-12-01
N214622-00290678962028-08-06Drug substance2021-06-08
N214622-00285520022029-08-25Drug substance, Drug product2021-06-08
N214622-002102789692034-12-11Drug product2021-06-08
N214622-002111608042034-12-11Drug product2021-12-01

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 4 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N214622-001NCE2026-05-28
N214622-001ODE-3532028-05-28
N214622-002NCE2026-05-28
N214622-002ODE-3532028-05-28

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N214622-001TRUSELTIQ25MGCAPSULE / ORALRLD2021-05-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214622-002TRUSELTIQ100MGCAPSULE / ORALRLD2021-05-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214622-001TRUSELTIQ25MGCAPSULE / ORALRLD2021-05-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214622-002TRUSELTIQ100MGCAPSULE / ORALRLD2021-05-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08N214622-001TRUSELTIQ25MGCAPSULE / ORALRLD2021-05-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214622-002TRUSELTIQ100MGCAPSULE / ORALRLD2021-05-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214622-001TRUSELTIQ25MGCAPSULE / ORALRLD2021-05-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214622-002TRUSELTIQ100MGCAPSULE / ORALRLD2021-05-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214622-001TRUSELTIQ25MGCAPSULE / ORALRLD2021-05-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214622-002TRUSELTIQ100MGCAPSULE / ORALRLD2021-05-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N214622-001TRUSELTIQ25MGCAPSULE / ORALRLD2021-05-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N214622-002TRUSELTIQ100MGCAPSULE / ORALRLD2021-05-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N214622-001TRUSELTIQ25MGCAPSULE / ORALRLD2021-05-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N214622-002TRUSELTIQ100MGCAPSULE / ORALRLD2021-05-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N214622-001TRUSELTIQ25MGCAPSULE / ORALRLD2021-05-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N214622-002TRUSELTIQ100MGCAPSULE / ORALRLD2021-05-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N214622-001TRUSELTIQ25MGCAPSULE / ORALRLD2021-05-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N214622-002TRUSELTIQ100MGCAPSULE / ORALRLD2021-05-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N214622-001TRUSELTIQ25MGCAPSULE / ORALRLD2021-05-28d06236e962d9…
2024-10-29 15:01 UTC2024-10N214622-002TRUSELTIQ100MGCAPSULE / ORALRLD2021-05-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N214622-001TRUSELTIQ25MGCAPSULE / ORALRLD2021-05-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N214622-002TRUSELTIQ100MGCAPSULE / ORALRLD2021-05-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N214622-001TRUSELTIQ25MGCAPSULE / ORALRLD2021-05-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N214622-002TRUSELTIQ100MGCAPSULE / ORALRLD2021-05-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N214622-001TRUSELTIQ25MGCAPSULE / ORALRLD2021-05-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N214622-002TRUSELTIQ100MGCAPSULE / ORALRLD2021-05-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05N214622-001TRUSELTIQ25MGCAPSULE / ORALRLD2021-05-288072bd15b7f6…
2024-05-31 18:47 UTC2024-05N214622-002TRUSELTIQ100MGCAPSULE / ORALRLD2021-05-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N214622-001TRUSELTIQ25MGCAPSULE / ORALRLD2021-05-285c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N214622-002TRUSELTIQ100MGCAPSULE / ORALRLD, RS2021-05-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N214622-001TRUSELTIQ25MGCAPSULE / ORALRLD2021-05-285d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N214622-002TRUSELTIQ100MGCAPSULE / ORALRLD, RS2021-05-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N214622-001TRUSELTIQ25MGCAPSULE / ORALRLD2021-05-284b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N214622-002TRUSELTIQ100MGCAPSULE / ORALRLD, RS2021-05-284b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N214622-001TRUSELTIQ25MGCAPSULE / ORALRLD2021-05-28bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N214622-002TRUSELTIQ100MGCAPSULE / ORALRLD, RS2021-05-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N214622-001TRUSELTIQ25MGCAPSULE / ORALRLD2021-05-28782e0a99824c…
2021-12-28 21:50 UTC2021-12N214622-002TRUSELTIQ100MGCAPSULE / ORALRLD, RS2021-05-28782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N214622-001TRUSELTIQ25MGCAPSULE / ORALRLD2021-05-286a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N214622-002TRUSELTIQ100MGCAPSULE / ORALRLD2021-05-286a51e52b5d6a…

Observed Orange Book patent history#

Patent history page 1 of 7 · 264 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N214622-00190678962028-08-06Drug substance2021-06-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214622-00185520022029-08-25Drug substance, Drug product2021-06-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214622-001102789692034-12-11Drug product2021-06-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214622-001111608042034-12-11Drug product2021-12-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214622-00290678962028-08-06Drug substance2021-06-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214622-00285520022029-08-25Drug substance, Drug product2021-06-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214622-002102789692034-12-11Drug product2021-06-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214622-002111608042034-12-11Drug product2021-12-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214622-00190678962028-08-06Drug substance2021-06-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214622-00185520022029-08-25Drug substance, Drug product2021-06-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214622-001102789692034-12-11Drug product2021-06-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214622-001111608042034-12-11Drug product2021-12-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214622-00290678962028-08-06Drug substance2021-06-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214622-00285520022029-08-25Drug substance, Drug product2021-06-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214622-002102789692034-12-11Drug product2021-06-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214622-002111608042034-12-11Drug product2021-12-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08N214622-00190678962028-08-06Drug substance2021-06-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214622-00185520022029-08-25Drug substance, Drug product2021-06-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214622-001102789692034-12-11Drug product2021-06-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214622-001111608042034-12-11Drug product2021-12-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214622-00290678962028-08-06Drug substance2021-06-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214622-00285520022029-08-25Drug substance, Drug product2021-06-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214622-002102789692034-12-11Drug product2021-06-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214622-002111608042034-12-11Drug product2021-12-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214622-00190678962028-08-06Drug substance2021-06-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214622-00185520022029-08-25Drug substance, Drug product2021-06-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214622-001102789692034-12-11Drug product2021-06-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214622-001111608042034-12-11Drug product2021-12-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214622-00290678962028-08-06Drug substance2021-06-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214622-00285520022029-08-25Drug substance, Drug product2021-06-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214622-002102789692034-12-11Drug product2021-06-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214622-002111608042034-12-11Drug product2021-12-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214622-00190678962028-08-06Drug substance2021-06-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214622-00185520022029-08-25Drug substance, Drug product2021-06-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214622-001102789692034-12-11Drug product2021-06-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214622-001111608042034-12-11Drug product2021-12-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214622-00290678962028-08-06Drug substance2021-06-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214622-00285520022029-08-25Drug substance, Drug product2021-06-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214622-002102789692034-12-11Drug product2021-06-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214622-002111608042034-12-11Drug product2021-12-01b8a1b40f171c…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-02-19 14:30 UTC2026-02N214622-001NCE2026-05-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214622-001ODE-3532028-05-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214622-002NCE2026-05-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214622-002ODE-3532028-05-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214622-001NCE2026-05-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214622-001ODE-3532028-05-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214622-002NCE2026-05-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214622-002ODE-3532028-05-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08N214622-001NCE2026-05-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214622-001ODE-3532028-05-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214622-002NCE2026-05-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214622-002ODE-3532028-05-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214622-001NCE2026-05-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214622-001ODE-3532028-05-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214622-002NCE2026-05-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214622-002ODE-3532028-05-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214622-001NCE2026-05-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214622-001ODE-3532028-05-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214622-002NCE2026-05-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214622-002ODE-3532028-05-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N214622-001NCE2026-05-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N214622-001ODE-3532028-05-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N214622-002NCE2026-05-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N214622-002ODE-3532028-05-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N214622-001NCE2026-05-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N214622-001ODE-3532028-05-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N214622-002NCE2026-05-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N214622-002ODE-3532028-05-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N214622-001NCE2026-05-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N214622-001ODE-3532028-05-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N214622-002NCE2026-05-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N214622-002ODE-3532028-05-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N214622-001NCE2026-05-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N214622-001ODE-3532028-05-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N214622-002NCE2026-05-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N214622-002ODE-3532028-05-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N214622-001NCE2026-05-28d06236e962d9…
2024-10-29 15:01 UTC2024-10N214622-001ODE-3532028-05-28d06236e962d9…
2024-10-29 15:01 UTC2024-10N214622-002NCE2026-05-28d06236e962d9…
2024-10-29 15:01 UTC2024-10N214622-002ODE-3532028-05-28d06236e962d9…

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
72730-101TRUSELTIQinfigratinibQED Therapeutics, Inc.NDACurrent
72730-101TRUSELTIQinfigratinibQED Therapeutics, Inc.NDACurrent
72730-101TRUSELTIQinfigratinibQED Therapeutics, Inc.NDACurrent
72730-111TRUSELTIQinfigratinibQED Therapeutics, Inc.NDACurrent
72730-111TRUSELTIQinfigratinibQED Therapeutics, Inc.NDACurrent
72730-111TRUSELTIQinfigratinibQED Therapeutics, Inc.NDACurrent
72730-202TRUSELTIQinfigratinibQED Therapeutics, Inc.NDACurrent
72730-202TRUSELTIQinfigratinibQED Therapeutics, Inc.NDACurrent
72730-202TRUSELTIQinfigratinibQED Therapeutics, Inc.NDACurrent
72730-506TRUSELTIQinfigratinibQED Therapeutics, Inc.NDACurrent
72730-506TRUSELTIQinfigratinibQED Therapeutics, Inc.NDACurrent
72730-506TRUSELTIQinfigratinibQED Therapeutics, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
67905ORIG2021-06-25
67635ORIG2021-06-01
67630ORIG2021-05-28