Application 218944

Type: NDA
Sponsor: SYNDAX

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	REVUFORJ	REVUMENIB CITRATE	TABLET;ORAL	EQ 25MG BASE	Yes	No
002	REVUFORJ	REVUMENIB CITRATE	TABLET;ORAL	EQ 110MG BASE	Yes	No
003	REVUFORJ	REVUMENIB CITRATE	TABLET;ORAL	EQ 160MG BASE	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N218944-001	REVUFORJ	REVUMENIB CITRATE	EQ 25MG BASE	TABLET / ORAL	RLD	2024-11-15
N218944-002	REVUFORJ	REVUMENIB CITRATE	EQ 110MG BASE	TABLET / ORAL	RLD	2024-11-15
N218944-003	REVUFORJ	REVUMENIB CITRATE	EQ 160MG BASE	TABLET / ORAL	RLD, RS	2024-11-15

Orange Book patents#

Current patent rows page 1 of 1 · 15 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N218944-001	10683302	2037-06-08		Drug substance, Drug product	2024-12-13
N218944-001	11479557	2037-06-08	U-4045	Drug product	2024-12-13
N218944-001	11479557	2037-06-08	U-4327	Drug product	2024-12-13
N218944-001	12564590	2042-12-18	U-4045	Drug product	2026-03-31
N218944-001	12564590	2042-12-18	U-4327	Drug product	2026-03-31
N218944-002	10683302	2037-06-08		Drug substance, Drug product	2024-12-13
N218944-002	11479557	2037-06-08	U-4045	Drug product	2024-12-13
N218944-002	11479557	2037-06-08	U-4327	Drug product	2024-12-13
N218944-002	12564590	2042-12-18	U-4045	Drug product	2026-03-31
N218944-002	12564590	2042-12-18	U-4327	Drug product	2026-03-31
N218944-003	10683302	2037-06-08		Drug substance, Drug product	2024-12-13
N218944-003	11479557	2037-06-08	U-4045	Drug product	2024-12-13
N218944-003	11479557	2037-06-08	U-4327	Drug product	2024-12-13
N218944-003	12564590	2042-12-18	U-4045	Drug product	2026-03-31
N218944-003	12564590	2042-12-18	U-4327	Drug product	2026-03-31

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 12 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N218944-001	NCE	2029-11-15
N218944-001	ODE-502	2031-11-15
N218944-001	ODE-504	2031-11-15
N218944-001	ODE-505	2031-11-15
N218944-002	NCE	2029-11-15
N218944-002	ODE-502	2031-11-15
N218944-002	ODE-504	2031-11-15
N218944-002	ODE-505	2031-11-15
N218944-003	NCE	2029-11-15
N218944-003	ODE-502	2031-11-15
N218944-003	ODE-504	2031-11-15
N218944-003	ODE-505	2031-11-15

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
2026-10-15 13:18:30	2026-09	N218944-001	REVUFORJ	EQ 25MG BASE	TABLET / ORAL	RLD	2024-11-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N218944-002	REVUFORJ	EQ 110MG BASE	TABLET / ORAL	RLD	2024-11-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N218944-003	REVUFORJ	EQ 160MG BASE	TABLET / ORAL	RLD, RS	2024-11-15	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N218944-001	REVUFORJ	EQ 25MG BASE	TABLET / ORAL	RLD	2024-11-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218944-002	REVUFORJ	EQ 110MG BASE	TABLET / ORAL	RLD	2024-11-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218944-003	REVUFORJ	EQ 160MG BASE	TABLET / ORAL	RLD, RS	2024-11-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N218944-001	REVUFORJ	EQ 25MG BASE	TABLET / ORAL	RLD	2024-11-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218944-002	REVUFORJ	EQ 110MG BASE	TABLET / ORAL	RLD	2024-11-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218944-003	REVUFORJ	EQ 160MG BASE	TABLET / ORAL	RLD, RS	2024-11-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N218944-001	REVUFORJ	EQ 25MG BASE	TABLET / ORAL	RLD	2024-11-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218944-002	REVUFORJ	EQ 110MG BASE	TABLET / ORAL	RLD	2024-11-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218944-003	REVUFORJ	EQ 160MG BASE	TABLET / ORAL	RLD, RS	2024-11-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218944-001	REVUFORJ	EQ 25MG BASE	TABLET / ORAL	RLD	2024-11-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218944-002	REVUFORJ	EQ 110MG BASE	TABLET / ORAL	RLD	2024-11-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218944-003	REVUFORJ	EQ 160MG BASE	TABLET / ORAL	RLD, RS	2024-11-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N218944-001	REVUFORJ	EQ 25MG BASE	TABLET / ORAL	RLD	2024-11-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218944-002	REVUFORJ	EQ 110MG BASE	TABLET / ORAL	RLD	2024-11-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218944-003	REVUFORJ	EQ 160MG BASE	TABLET / ORAL	RLD, RS	2024-11-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218944-001	REVUFORJ	EQ 25MG BASE	TABLET / ORAL	RLD	2024-11-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218944-002	REVUFORJ	EQ 110MG BASE	TABLET / ORAL	RLD	2024-11-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218944-003	REVUFORJ	EQ 160MG BASE	TABLET / ORAL	RLD, RS	2024-11-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218944-001	REVUFORJ	EQ 25MG BASE	TABLET / ORAL	RLD	2024-11-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218944-002	REVUFORJ	EQ 110MG BASE	TABLET / ORAL	RLD	2024-11-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218944-003	REVUFORJ	EQ 160MG BASE	TABLET / ORAL	RLD, RS	2024-11-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218944-001	REVUFORJ	EQ 25MG BASE	TABLET / ORAL	RLD	2024-11-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218944-002	REVUFORJ	EQ 110MG BASE	TABLET / ORAL	RLD	2024-11-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218944-003	REVUFORJ	EQ 160MG BASE	TABLET / ORAL	RLD, RS	2024-11-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N218944-001	REVUFORJ	EQ 25MG BASE	TABLET / ORAL	RLD	2024-11-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N218944-002	REVUFORJ	EQ 110MG BASE	TABLET / ORAL	RLD	2024-11-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N218944-003	REVUFORJ	EQ 160MG BASE	TABLET / ORAL	RLD, RS	2024-11-15	`2680178bc6a6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218944-001	REVUFORJ	EQ 25MG BASE	TABLET / ORAL	RLD	2024-11-15	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218944-002	REVUFORJ	EQ 110MG BASE	TABLET / ORAL	RLD	2024-11-15	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218944-003	REVUFORJ	EQ 160MG BASE	TABLET / ORAL	RLD, RS	2024-11-15	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 102 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	N218944-001	10683302	2037-06-08		Drug substance, Drug product	2024-12-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N218944-001	11479557	2037-06-08	U-4327	Drug product	2024-12-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N218944-001	11479557	2037-06-08	U-4045	Drug product	2024-12-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N218944-001	12564590	2042-12-18	U-4045	Drug product	2026-03-31	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N218944-001	12564590	2042-12-18	U-4327	Drug product	2026-03-31	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N218944-002	10683302	2037-06-08		Drug substance, Drug product	2024-12-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N218944-002	11479557	2037-06-08	U-4327	Drug product	2024-12-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N218944-002	11479557	2037-06-08	U-4045	Drug product	2024-12-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N218944-002	12564590	2042-12-18	U-4327	Drug product	2026-03-31	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N218944-002	12564590	2042-12-18	U-4045	Drug product	2026-03-31	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N218944-003	10683302	2037-06-08		Drug substance, Drug product	2024-12-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N218944-003	11479557	2037-06-08	U-4327	Drug product	2024-12-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N218944-003	11479557	2037-06-08	U-4045	Drug product	2024-12-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N218944-003	12564590	2042-12-18	U-4327	Drug product	2026-03-31	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N218944-003	12564590	2042-12-18	U-4045	Drug product	2026-03-31	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N218944-001	10683302	2037-06-08		Drug substance, Drug product	2024-12-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218944-001	11479557	2037-06-08	U-4327	Drug product	2024-12-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218944-001	11479557	2037-06-08	U-4045	Drug product	2024-12-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218944-001	12564590	2042-12-18	U-4045	Drug product	2026-03-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218944-001	12564590	2042-12-18	U-4327	Drug product	2026-03-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218944-002	10683302	2037-06-08		Drug substance, Drug product	2024-12-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218944-002	11479557	2037-06-08	U-4327	Drug product	2024-12-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218944-002	11479557	2037-06-08	U-4045	Drug product	2024-12-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218944-002	12564590	2042-12-18	U-4327	Drug product	2026-03-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218944-002	12564590	2042-12-18	U-4045	Drug product	2026-03-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218944-003	10683302	2037-06-08		Drug substance, Drug product	2024-12-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218944-003	11479557	2037-06-08	U-4327	Drug product	2024-12-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218944-003	11479557	2037-06-08	U-4045	Drug product	2024-12-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218944-003	12564590	2042-12-18	U-4327	Drug product	2026-03-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218944-003	12564590	2042-12-18	U-4045	Drug product	2026-03-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N218944-001	10683302	2037-06-08		Drug substance, Drug product	2024-12-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218944-001	11479557	2037-06-08	U-4327	Drug product	2024-12-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218944-001	11479557	2037-06-08	U-4045	Drug product	2024-12-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218944-001	12564590	2042-12-18	U-4045	Drug product	2026-03-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218944-001	12564590	2042-12-18	U-4327	Drug product	2026-03-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218944-002	10683302	2037-06-08		Drug substance, Drug product	2024-12-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218944-002	11479557	2037-06-08	U-4327	Drug product	2024-12-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218944-002	11479557	2037-06-08	U-4045	Drug product	2024-12-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218944-002	12564590	2042-12-18	U-4327	Drug product	2026-03-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218944-002	12564590	2042-12-18	U-4045	Drug product	2026-03-31	`caaa826d4ba7…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 117 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-10-15 13:18:30	2026-09	N218944-001	NCE	2029-11-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N218944-001	ODE-502	2031-11-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N218944-001	ODE-504	2031-11-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N218944-001	ODE-505	2031-11-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N218944-002	NCE	2029-11-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N218944-002	ODE-502	2031-11-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N218944-002	ODE-504	2031-11-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N218944-002	ODE-505	2031-11-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N218944-003	NCE	2029-11-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N218944-003	ODE-502	2031-11-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N218944-003	ODE-504	2031-11-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N218944-003	ODE-505	2031-11-15	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N218944-001	NCE	2029-11-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218944-001	ODE-502	2031-11-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218944-001	ODE-504	2031-11-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218944-001	ODE-505	2031-11-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218944-002	NCE	2029-11-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218944-002	ODE-502	2031-11-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218944-002	ODE-504	2031-11-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218944-002	ODE-505	2031-11-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218944-003	NCE	2029-11-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218944-003	ODE-502	2031-11-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218944-003	ODE-504	2031-11-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218944-003	ODE-505	2031-11-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N218944-001	NCE	2029-11-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218944-001	ODE-502	2031-11-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218944-001	ODE-504	2031-11-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218944-001	ODE-505	2031-11-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218944-002	NCE	2029-11-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218944-002	ODE-502	2031-11-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218944-002	ODE-504	2031-11-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218944-002	ODE-505	2031-11-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218944-003	NCE	2029-11-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218944-003	ODE-502	2031-11-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218944-003	ODE-504	2031-11-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218944-003	ODE-505	2031-11-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N218944-001	NCE	2029-11-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218944-001	ODE-502	2031-11-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218944-001	ODE-504	2031-11-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218944-001	ODE-505	2031-11-15	`011fe1cb6892…`

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
Revuforj	REVUMENIB	Syndax Pharmaceuticals, Inc.	6eb3cdbc-0e74-477d-82d6-3bb172d3f63f	2026-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 218944 application number: NDA218944

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
83946	SUPPL	2025-10-28
83922	SUPPL	2025-10-27
83921	SUPPL	2025-10-27
80556	ORIG	2024-12-11
80241	ORIG	2024-11-19
80225	ORIG	2024-11-18