Application 214783

Type: NDA
Sponsor: KADMON PHARMA LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	REZUROCK	BELUMOSUDIL	TABLET;ORAL	200MG	No	No

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N214783-001	REZUROCK	BELUMOSUDIL MESYLATE	EQ 200MG BASE	TABLET / ORAL		RLD, RS	2021-07-16

Orange Book patents#

Current patent rows page 1 of 1 · 7 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N214783-001	10183931	2033-10-07	U-3246		2021-11-17
N214783-001	10183931	2033-10-07	U-4260		2021-11-17
N214783-001	10696660	2033-10-07	U-3246		2021-11-17
N214783-001	10696660	2033-10-07	U-4260		2021-11-17
N214783-001	8357693	2034-06-20	U-4259	Drug substance, Drug product	2021-11-17
N214783-001	11311541	2035-04-09	U-3369		2022-05-25
N214783-001	12097202	2042-07-14	U-4014		2024-10-24

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N214783-001	NCE	2026-07-16
N214783-001	ODE-362	2028-07-16

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	N214783-001	REZUROCK	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2021-07-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N214783-001	REZUROCK	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2021-07-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214783-001	REZUROCK	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2021-07-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214783-001	REZUROCK	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2021-07-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214783-001	REZUROCK	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2021-07-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214783-001	REZUROCK	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2021-07-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214783-001	REZUROCK	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2021-07-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214783-001	REZUROCK	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2021-07-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214783-001	REZUROCK	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2021-07-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214783-001	REZUROCK	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2021-07-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214783-001	REZUROCK	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2021-07-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214783-001	REZUROCK	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2021-07-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214783-001	REZUROCK	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2021-07-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214783-001	REZUROCK	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2021-07-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214783-001	REZUROCK	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2021-07-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214783-001	REZUROCK	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2021-07-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214783-001	REZUROCK	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2021-07-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N214783-001	REZUROCK	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2021-07-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N214783-001	REZUROCK	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2021-07-16	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N214783-001	REZUROCK	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2021-07-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N214783-001	REZUROCK	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2021-07-16	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214783-001	REZUROCK	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2021-07-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N214783-001	REZUROCK	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2021-07-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N214783-001	REZUROCK	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2021-07-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N214783-001	REZUROCK	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2021-07-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N214783-001	REZUROCK	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2021-07-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N214783-001	REZUROCK	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2021-07-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N214783-001	REZUROCK	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2021-07-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N214783-001	REZUROCK	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2021-07-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N214783-001	REZUROCK	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2021-07-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N214783-001	REZUROCK	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2021-07-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N214783-001	REZUROCK	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2021-07-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N214783-001	REZUROCK	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2021-07-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N214783-001	REZUROCK	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2021-07-16	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214783-001	REZUROCK	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2021-07-16	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 181 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	N214783-001	10183931	2033-10-07	U-4260		2021-11-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214783-001	10183931	2033-10-07	U-3246		2021-11-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214783-001	10696660	2033-10-07	U-4260		2021-11-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214783-001	10696660	2033-10-07	U-3246		2021-11-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214783-001	8357693	2034-06-20	U-4259	Drug substance, Drug product	2021-11-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214783-001	11311541	2035-04-09	U-3369		2022-05-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214783-001	12097202	2042-07-14	U-4014		2024-10-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N214783-001	10183931	2033-10-07	U-4260		2021-11-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214783-001	10183931	2033-10-07	U-3246		2021-11-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214783-001	10696660	2033-10-07	U-4260		2021-11-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214783-001	10696660	2033-10-07	U-3246		2021-11-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214783-001	8357693	2034-06-20	U-4259	Drug substance, Drug product	2021-11-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214783-001	11311541	2035-04-09	U-3369		2022-05-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214783-001	12097202	2042-07-14	U-4014		2024-10-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214783-001	10183931	2033-10-07	U-4260		2021-11-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214783-001	10183931	2033-10-07	U-3246		2021-11-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214783-001	10696660	2033-10-07	U-4260		2021-11-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214783-001	10696660	2033-10-07	U-3246		2021-11-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214783-001	8357693	2034-06-20	U-4259	Drug substance, Drug product	2021-11-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214783-001	11311541	2035-04-09	U-3369		2022-05-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214783-001	12097202	2042-07-14	U-4014		2024-10-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214783-001	10183931	2033-10-07	U-4260		2021-11-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214783-001	10183931	2033-10-07	U-3246		2021-11-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214783-001	10696660	2033-10-07	U-4260		2021-11-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214783-001	10696660	2033-10-07	U-3246		2021-11-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214783-001	8357693	2034-06-20	U-4259	Drug substance, Drug product	2021-11-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214783-001	11311541	2035-04-09	U-3369		2022-05-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214783-001	12097202	2042-07-14	U-4014		2024-10-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214783-001	8357693	2029-10-30	U-3247	Drug substance, Drug product	2021-11-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214783-001	10183931	2033-10-07	U-3246		2021-11-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214783-001	10696660	2033-10-07	U-3246		2021-11-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214783-001	11311541	2035-04-09	U-3369		2022-05-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214783-001	12097202	2042-07-14	U-4014		2024-10-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214783-001	8357693	2029-10-30	U-3247	Drug substance, Drug product	2021-11-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214783-001	10183931	2033-10-07	U-3246		2021-11-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214783-001	10696660	2033-10-07	U-3246		2021-11-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214783-001	11311541	2035-04-09	U-3369		2022-05-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214783-001	12097202	2042-07-14	U-4014		2024-10-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214783-001	8357693	2029-10-30	U-3247	Drug substance, Drug product	2021-11-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214783-001	10183931	2033-10-07	U-3246		2021-11-17	`b8a1b40f171c…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 70 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N214783-001	NCE	2026-07-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214783-001	ODE-362	2028-07-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N214783-001	NCE	2026-07-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214783-001	ODE-362	2028-07-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214783-001	NCE	2026-07-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214783-001	ODE-362	2028-07-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214783-001	NCE	2026-07-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214783-001	ODE-362	2028-07-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214783-001	NCE	2026-07-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214783-001	ODE-362	2028-07-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214783-001	NCE	2026-07-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214783-001	ODE-362	2028-07-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214783-001	NCE	2026-07-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214783-001	ODE-362	2028-07-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214783-001	NCE	2026-07-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214783-001	ODE-362	2028-07-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214783-001	NCE	2026-07-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214783-001	ODE-362	2028-07-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214783-001	NCE	2026-07-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214783-001	ODE-362	2028-07-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214783-001	NCE	2026-07-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214783-001	ODE-362	2028-07-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214783-001	NCE	2026-07-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N214783-001	ODE-362	2028-07-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214783-001	NCE	2026-07-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214783-001	ODE-362	2028-07-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214783-001	NCE	2026-07-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214783-001	ODE-362	2028-07-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214783-001	NCE	2026-07-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214783-001	ODE-362	2028-07-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214783-001	NCE	2026-07-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N214783-001	ODE-362	2028-07-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214783-001	NCE	2026-07-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214783-001	ODE-362	2028-07-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N214783-001	NCE	2026-07-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N214783-001	ODE-362	2028-07-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N214783-001	NCE	2026-07-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N214783-001	ODE-362	2028-07-16	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N214783-001	NCE	2026-07-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N214783-001	ODE-362	2028-07-16	`bb7c543d1eb4…`

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
Rezurock	BELUMOSUDIL	Kadmon Pharmaceuticals, LLC	102e4ef4-7f84-4e34-8df1-479c24d1575d	2026-04-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 214783 application number: NDA214783 ndc (product): 79802-200

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 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
79802-200	Rezurock	belumosudil	Kadmon Pharmaceuticals, LLC	NDA	Current
79802-200	Rezurock	belumosudil	Kadmon Pharmaceuticals, LLC	NDA	Current
79802-200	Rezurock	belumosudil	Kadmon Pharmaceuticals, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84809	SUPPL	2026-01-21
80793	SUPPL	2025-01-02
80790	SUPPL	2025-01-02
78112	SUPPL	2024-04-12
78109	SUPPL	2024-04-11
76564	SUPPL	2023-11-14
76556	SUPPL	2023-11-13
68370	ORIG	2021-08-13
68135	ORIG	2021-07-20
68114	ORIG	2021-07-19