Application 217564

Type: NDA
Sponsor: TAKEDA PHARMS USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FRUZAQLA	FRUQUINTINIB	CAPSULE;ORAL	1MG	Yes	No
002	FRUZAQLA	FRUQUINTINIB	CAPSULE;ORAL	5MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N217564-001	FRUZAQLA	FRUQUINTINIB	1MG	CAPSULE / ORAL		RLD	2023-11-08
N217564-002	FRUZAQLA	FRUQUINTINIB	5MG	CAPSULE / ORAL		RLD, RS	2023-11-08

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
N217564-001	8212033	2028-05-09	U-3753		2023-12-06
N217564-001	7829574	2032-03-23		Drug substance, Drug product	2023-12-06
N217564-001	10519142	2035-09-07	U-3753	Drug substance, Drug product	2023-12-06
N217564-001	11046674	2035-09-07	U-3753		2023-12-06
N217564-002	8212033	2028-05-09	U-3753		2023-12-06
N217564-002	7829574	2032-03-23		Drug substance, Drug product	2023-12-06
N217564-002	10519142	2035-09-07	U-3753	Drug substance, Drug product	2023-12-06
N217564-002	11046674	2035-09-07	U-3753		2023-12-06

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N217564-001	NCE	2028-11-08
N217564-002	NCE	2028-11-08

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N217564-001	FRUZAQLA	1MG	CAPSULE / ORAL	RLD	2023-11-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217564-002	FRUZAQLA	5MG	CAPSULE / ORAL	RLD, RS	2023-11-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N217564-001	FRUZAQLA	1MG	CAPSULE / ORAL	RLD	2023-11-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217564-002	FRUZAQLA	5MG	CAPSULE / ORAL	RLD, RS	2023-11-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N217564-001	FRUZAQLA	1MG	CAPSULE / ORAL	RLD	2023-11-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217564-002	FRUZAQLA	5MG	CAPSULE / ORAL	RLD, RS	2023-11-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217564-001	FRUZAQLA	1MG	CAPSULE / ORAL	RLD	2023-11-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217564-002	FRUZAQLA	5MG	CAPSULE / ORAL	RLD, RS	2023-11-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217564-001	FRUZAQLA	1MG	CAPSULE / ORAL	RLD	2023-11-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217564-002	FRUZAQLA	5MG	CAPSULE / ORAL	RLD, RS	2023-11-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217564-001	FRUZAQLA	1MG	CAPSULE / ORAL	RLD	2023-11-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217564-002	FRUZAQLA	5MG	CAPSULE / ORAL	RLD, RS	2023-11-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217564-001	FRUZAQLA	1MG	CAPSULE / ORAL	RLD	2023-11-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217564-002	FRUZAQLA	5MG	CAPSULE / ORAL	RLD, RS	2023-11-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217564-001	FRUZAQLA	1MG	CAPSULE / ORAL	RLD	2023-11-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217564-002	FRUZAQLA	5MG	CAPSULE / ORAL	RLD, RS	2023-11-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217564-001	FRUZAQLA	1MG	CAPSULE / ORAL	RLD	2023-11-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217564-002	FRUZAQLA	5MG	CAPSULE / ORAL	RLD, RS	2023-11-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217564-001	FRUZAQLA	1MG	CAPSULE / ORAL	RLD	2023-11-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217564-002	FRUZAQLA	5MG	CAPSULE / ORAL	RLD, RS	2023-11-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217564-001	FRUZAQLA	1MG	CAPSULE / ORAL	RLD	2023-11-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217564-002	FRUZAQLA	5MG	CAPSULE / ORAL	RLD, RS	2023-11-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N217564-001	FRUZAQLA	1MG	CAPSULE / ORAL	RLD	2023-11-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N217564-002	FRUZAQLA	5MG	CAPSULE / ORAL	RLD, RS	2023-11-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217564-001	FRUZAQLA	1MG	CAPSULE / ORAL	RLD	2023-11-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217564-002	FRUZAQLA	5MG	CAPSULE / ORAL	RLD, RS	2023-11-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217564-001	FRUZAQLA	1MG	CAPSULE / ORAL	RLD	2023-11-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217564-002	FRUZAQLA	5MG	CAPSULE / ORAL	RLD, RS	2023-11-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217564-001	FRUZAQLA	1MG	CAPSULE / ORAL	RLD	2023-11-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217564-002	FRUZAQLA	5MG	CAPSULE / ORAL	RLD, RS	2023-11-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N217564-001	FRUZAQLA	1MG	CAPSULE / ORAL	RLD	2023-11-08	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N217564-002	FRUZAQLA	5MG	CAPSULE / ORAL	RLD, RS	2023-11-08	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N217564-001	FRUZAQLA	1MG	CAPSULE / ORAL	RLD	2023-11-08	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N217564-002	FRUZAQLA	5MG	CAPSULE / ORAL	RLD, RS	2023-11-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N217564-001	FRUZAQLA	1MG	CAPSULE / ORAL	RLD	2023-11-08	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N217564-002	FRUZAQLA	5MG	CAPSULE / ORAL	RLD, RS	2023-11-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N217564-001	FRUZAQLA	1MG	CAPSULE / ORAL	RLD	2023-11-08	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N217564-002	FRUZAQLA	5MG	CAPSULE / ORAL	RLD, RS	2023-11-08	`ea1830bbd6c7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217564-001	FRUZAQLA	1MG	CAPSULE / ORAL	RLD	2023-11-08	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217564-002	FRUZAQLA	5MG	CAPSULE / ORAL	RLD, RS	2023-11-08	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 160 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N217564-001	8212033	2028-05-09	U-3753		2023-12-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217564-001	7829574	2032-03-23		Drug substance, Drug product	2023-12-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217564-001	10519142	2035-09-07	U-3753	Drug substance, Drug product	2023-12-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217564-001	11046674	2035-09-07	U-3753		2023-12-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217564-002	8212033	2028-05-09	U-3753		2023-12-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217564-002	7829574	2032-03-23		Drug substance, Drug product	2023-12-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217564-002	10519142	2035-09-07	U-3753	Drug substance, Drug product	2023-12-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217564-002	11046674	2035-09-07	U-3753		2023-12-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N217564-001	8212033	2028-05-09	U-3753		2023-12-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217564-001	7829574	2032-03-23		Drug substance, Drug product	2023-12-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217564-001	10519142	2035-09-07	U-3753	Drug substance, Drug product	2023-12-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217564-001	11046674	2035-09-07	U-3753		2023-12-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217564-002	8212033	2028-05-09	U-3753		2023-12-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217564-002	7829574	2032-03-23		Drug substance, Drug product	2023-12-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217564-002	10519142	2035-09-07	U-3753	Drug substance, Drug product	2023-12-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217564-002	11046674	2035-09-07	U-3753		2023-12-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N217564-001	8212033	2028-05-09	U-3753		2023-12-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217564-001	7829574	2032-03-23		Drug substance, Drug product	2023-12-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217564-001	10519142	2035-09-07	U-3753	Drug substance, Drug product	2023-12-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217564-001	11046674	2035-09-07	U-3753		2023-12-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217564-002	8212033	2028-05-09	U-3753		2023-12-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217564-002	7829574	2032-03-23		Drug substance, Drug product	2023-12-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217564-002	10519142	2035-09-07	U-3753	Drug substance, Drug product	2023-12-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217564-002	11046674	2035-09-07	U-3753		2023-12-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217564-001	7829574	2028-05-09		Drug substance, Drug product	2023-12-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217564-001	8212033	2028-05-09	U-3753		2023-12-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217564-001	10519142	2035-09-07	U-3753	Drug substance, Drug product	2023-12-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217564-001	11046674	2035-09-07	U-3753		2023-12-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217564-002	7829574	2028-05-09		Drug substance, Drug product	2023-12-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217564-002	8212033	2028-05-09	U-3753		2023-12-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217564-002	10519142	2035-09-07	U-3753	Drug substance, Drug product	2023-12-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217564-002	11046674	2035-09-07	U-3753		2023-12-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217564-001	7829574	2028-05-09		Drug substance, Drug product	2023-12-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217564-001	8212033	2028-05-09	U-3753		2023-12-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217564-001	10519142	2035-09-07	U-3753	Drug substance, Drug product	2023-12-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217564-001	11046674	2035-09-07	U-3753		2023-12-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217564-002	7829574	2028-05-09		Drug substance, Drug product	2023-12-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217564-002	8212033	2028-05-09	U-3753		2023-12-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217564-002	10519142	2035-09-07	U-3753	Drug substance, Drug product	2023-12-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217564-002	11046674	2035-09-07	U-3753		2023-12-06	`6a471c1ec25d…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N217564-001	NCE	2028-11-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217564-002	NCE	2028-11-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N217564-001	NCE	2028-11-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217564-002	NCE	2028-11-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N217564-001	NCE	2028-11-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217564-002	NCE	2028-11-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217564-001	NCE	2028-11-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217564-002	NCE	2028-11-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217564-001	NCE	2028-11-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217564-002	NCE	2028-11-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217564-001	NCE	2028-11-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217564-002	NCE	2028-11-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217564-001	NCE	2028-11-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217564-002	NCE	2028-11-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217564-001	NCE	2028-11-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217564-002	NCE	2028-11-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217564-001	NCE	2028-11-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217564-002	NCE	2028-11-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217564-001	NCE	2028-11-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217564-002	NCE	2028-11-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217564-001	NCE	2028-11-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217564-002	NCE	2028-11-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N217564-001	NCE	2028-11-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N217564-002	NCE	2028-11-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217564-001	NCE	2028-11-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217564-002	NCE	2028-11-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217564-001	NCE	2028-11-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217564-002	NCE	2028-11-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217564-001	NCE	2028-11-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217564-002	NCE	2028-11-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N217564-001	NCE	2028-11-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N217564-002	NCE	2028-11-30	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N217564-001	NCE	2028-11-30	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N217564-002	NCE	2028-11-30	`6a51e52b5d6a…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217564-001	NCE	2028-11-08	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217564-002	NCE	2028-11-08	`a50c72e98297…`

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fruzaqla	FRUQUINTINIB	Takeda Pharmaceuticals America, Inc.	186d786e-dc8a-45f2-b5e1-01ac0201879f	2026-07-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 217564 application number: NDA217564

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81428	SUPPL	2025-03-04
81390	SUPPL	2025-03-03
76717	ORIG	2023-12-04
76548	ORIG	2023-11-13
76542	ORIG	2023-11-08