Home Applications 214783 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 1 .
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 Product TE source text RLD / RS Approval date Source SHA-256 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…2026-08-01 22:54:32 2026-06 N214783-001 REZUROCK EQ 200MG BASE TABLET / ORAL RLD, RS 2021-07-16 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2023-05-13 08:27 UTC 2023-05 N214783-001 8357693 2029-10-30 U-3247 Drug substance, Drug product 2021-11-17 053a50430f4f…2023-05-13 08:27 UTC 2023-05 N214783-001 10183931 2033-10-07 U-3246 2021-11-17 053a50430f4f…2023-05-13 08:27 UTC 2023-05 N214783-001 10696660 2033-10-07 U-3246 2021-11-17 053a50430f4f…2023-05-13 08:27 UTC 2023-05 N214783-001 9815820 2033-10-07 U-3247 2021-11-17 053a50430f4f…2023-05-13 08:27 UTC 2023-05 N214783-001 11311541 2035-04-09 U-3369 2022-05-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N214783-001 8357693 2029-10-30 U-3247 Drug substance, Drug product 2021-11-17 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 N214783-001 10183931 2033-10-07 U-3246 2021-11-17 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 N214783-001 10696660 2033-10-07 U-3246 2021-11-17 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 N214783-001 9815820 2033-10-07 U-3247 2021-11-17 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 N214783-001 11311541 2035-04-09 U-3369 2022-05-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N214783-001 8357693 2029-10-30 U-3247 Drug substance, Drug product 2021-11-17 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N214783-001 10183931 2033-10-07 U-3246 2021-11-17 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N214783-001 10696660 2033-10-07 U-3246 2021-11-17 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N214783-001 9815820 2033-10-07 U-3247 2021-11-17 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N214783-001 11311541 2035-04-09 U-3369 2022-05-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N214783-001 8357693 2029-10-30 U-3247 Drug substance, Drug product 2021-11-17 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N214783-001 10183931 2033-10-07 U-3246 2021-11-17 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N214783-001 10696660 2033-10-07 U-3246 2021-11-17 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N214783-001 9815820 2033-10-07 U-3247 2021-11-17 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N214783-001 11311541 2035-04-09 U-3369 2022-05-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N214783-001 8357693 2029-10-30 U-3247 Drug substance, Drug product 2021-11-17 e64feba35796…2022-09-29 23:25 UTC 2022-09 N214783-001 10183931 2033-10-07 U-3246 2021-11-17 e64feba35796…2022-09-29 23:25 UTC 2022-09 N214783-001 10696660 2033-10-07 U-3246 2021-11-17 e64feba35796…2022-09-29 23:25 UTC 2022-09 N214783-001 9815820 2033-10-07 U-3247 2021-11-17 e64feba35796…2022-09-29 23:25 UTC 2022-09 N214783-001 11311541 2035-04-09 U-3369 2022-05-25 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N214783-001 8357693 2029-10-30 U-3247 Drug substance, Drug product 2021-11-17 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N214783-001 10183931 2033-10-07 U-3246 2021-11-17 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N214783-001 10696660 2033-10-07 U-3246 2021-11-17 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N214783-001 9815820 2033-10-07 U-3247 2021-11-17 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N214783-001 11311541 2035-04-09 U-3369 2022-05-25 cb3db0bc1861…2026-08-01 22:54:32 2026-06 N214783-001 10183931 2033-10-07 U-4260 2021-11-17 a50c72e98297…2026-08-01 22:54:32 2026-06 N214783-001 10183931 2033-10-07 U-3246 2021-11-17 a50c72e98297…2026-08-01 22:54:32 2026-06 N214783-001 10696660 2033-10-07 U-4260 2021-11-17 a50c72e98297…2026-08-01 22:54:32 2026-06 N214783-001 10696660 2033-10-07 U-3246 2021-11-17 a50c72e98297…2026-08-01 22:54:32 2026-06 N214783-001 8357693 2034-06-20 U-4259 Drug substance, Drug product 2021-11-17 a50c72e98297…2026-08-01 22:54:32 2026-06 N214783-001 11311541 2035-04-09 U-3369 2022-05-25 a50c72e98297…2026-08-01 22:54:32 2026-06 N214783-001 12097202 2042-07-14 U-4014 2024-10-24 a50c72e98297…
Observed Orange Book exclusivity history# openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
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