Home Applications 216951 Application 216951
Type NDA
Sponsor GLAXOSMITHKLINE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 JESDUVROQ DAPRODUSTAT TABLET;ORAL 1MG Yes No 002 JESDUVROQ DAPRODUSTAT TABLET;ORAL 2MG Yes No 003 JESDUVROQ DAPRODUSTAT TABLET;ORAL 4MG Yes No 004 JESDUVROQ DAPRODUSTAT TABLET;ORAL 6MG Yes No 005 JESDUVROQ DAPRODUSTAT TABLET;ORAL 8MG Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N216951-001 JESDUVROQ DAPRODUSTAT 1MG TABLET / ORAL RLD 2023-02-01 N216951-002 JESDUVROQ DAPRODUSTAT 2MG TABLET / ORAL RLD 2023-02-01 N216951-003 JESDUVROQ DAPRODUSTAT 4MG TABLET / ORAL RLD 2023-02-01 N216951-004 JESDUVROQ DAPRODUSTAT 6MG TABLET / ORAL RLD 2023-02-01 N216951-005 JESDUVROQ DAPRODUSTAT 8MG TABLET / ORAL RLD 2023-02-01
Orange Book patents# Current patent rows page 1 of 1 · 30 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N216951-001 11643397 2027-06-22 U-3535 Drug substance 2023-06-07 N216951-001 8557834 2027-06-22 U-1238 2023-02-21 N216951-001 8815884 2027-06-22 U-1238 Drug product 2023-02-21 N216951-001 8324208 2028-12-11 Drug substance, Drug product 2023-02-21 N216951-001 11117871 2038-03-13 U-3535 Drug substance, Drug product 2023-02-21 N216951-001 11649217 2038-03-13 U-3535 Drug product 2023-06-07 N216951-002 11643397 2027-06-22 U-3535 Drug substance 2023-06-07 N216951-002 8557834 2027-06-22 U-1238 2023-02-21 N216951-002 8815884 2027-06-22 U-1238 Drug product 2023-02-21 N216951-002 8324208 2028-12-11 Drug substance, Drug product 2023-02-21 N216951-002 11117871 2038-03-13 U-3535 Drug substance, Drug product 2023-02-21 N216951-002 11649217 2038-03-13 U-3535 Drug product 2023-06-07 N216951-003 11643397 2027-06-22 U-3535 Drug substance 2023-06-07 N216951-003 8557834 2027-06-22 U-1238 2023-02-21 N216951-003 8815884 2027-06-22 U-1238 Drug product 2023-02-21 N216951-003 8324208 2028-12-11 Drug substance, Drug product 2023-02-21 N216951-003 11117871 2038-03-13 U-3535 Drug substance, Drug product 2023-02-21 N216951-003 11649217 2038-03-13 U-3535 Drug product 2023-06-07 N216951-004 11643397 2027-06-22 U-3535 Drug substance 2023-06-07 N216951-004 8557834 2027-06-22 U-1238 2023-02-21 N216951-004 8815884 2027-06-22 U-1238 Drug product 2023-02-21 N216951-004 8324208 2028-12-11 Drug substance, Drug product 2023-02-21 N216951-004 11117871 2038-03-13 U-3535 Drug substance, Drug product 2023-02-21 N216951-004 11649217 2038-03-13 U-3535 Drug product 2023-06-07 N216951-005 11643397 2027-06-22 U-3535 Drug substance 2023-06-07 N216951-005 8557834 2027-06-22 U-1238 2023-02-21 N216951-005 8815884 2027-06-22 U-1238 Drug product 2023-02-21 N216951-005 8324208 2028-12-11 Drug substance, Drug product 2023-02-21 N216951-005 11117871 2038-03-13 U-3535 Drug substance, Drug product 2023-02-21 N216951-005 11649217 2038-03-13 U-3535 Drug product 2023-06-07
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 5 matching rows.
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 3 · 115 observed 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 2026-02-19 14:30 UTC 2026-02 N216951-001 JESDUVROQ 1MG TABLET / ORAL RLD 2023-02-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216951-002 JESDUVROQ 2MG TABLET / ORAL RLD 2023-02-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216951-003 JESDUVROQ 4MG TABLET / ORAL RLD 2023-02-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216951-004 JESDUVROQ 6MG TABLET / ORAL RLD 2023-02-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216951-005 JESDUVROQ 8MG TABLET / ORAL RLD 2023-02-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216951-001 JESDUVROQ 1MG TABLET / ORAL RLD 2023-02-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216951-002 JESDUVROQ 2MG TABLET / ORAL RLD 2023-02-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216951-003 JESDUVROQ 4MG TABLET / ORAL RLD 2023-02-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216951-004 JESDUVROQ 6MG TABLET / ORAL RLD 2023-02-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216951-005 JESDUVROQ 8MG TABLET / ORAL RLD 2023-02-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N216951-001 JESDUVROQ 1MG TABLET / ORAL RLD 2023-02-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216951-002 JESDUVROQ 2MG TABLET / ORAL RLD 2023-02-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216951-003 JESDUVROQ 4MG TABLET / ORAL RLD 2023-02-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216951-004 JESDUVROQ 6MG TABLET / ORAL RLD 2023-02-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216951-005 JESDUVROQ 8MG TABLET / ORAL RLD 2023-02-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216951-001 JESDUVROQ 1MG TABLET / ORAL RLD 2023-02-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216951-002 JESDUVROQ 2MG TABLET / ORAL RLD 2023-02-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216951-003 JESDUVROQ 4MG TABLET / ORAL RLD 2023-02-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216951-004 JESDUVROQ 6MG TABLET / ORAL RLD 2023-02-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216951-005 JESDUVROQ 8MG TABLET / ORAL RLD 2023-02-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216951-001 JESDUVROQ 1MG TABLET / ORAL RLD 2023-02-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216951-002 JESDUVROQ 2MG TABLET / ORAL RLD 2023-02-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216951-003 JESDUVROQ 4MG TABLET / ORAL RLD 2023-02-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216951-004 JESDUVROQ 6MG TABLET / ORAL RLD 2023-02-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216951-005 JESDUVROQ 8MG TABLET / ORAL RLD 2023-02-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216951-001 JESDUVROQ 1MG TABLET / ORAL RLD 2023-02-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216951-002 JESDUVROQ 2MG TABLET / ORAL RLD 2023-02-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216951-003 JESDUVROQ 4MG TABLET / ORAL RLD 2023-02-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216951-004 JESDUVROQ 6MG TABLET / ORAL RLD 2023-02-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216951-005 JESDUVROQ 8MG TABLET / ORAL RLD 2023-02-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216951-001 JESDUVROQ 1MG TABLET / ORAL RLD 2023-02-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216951-002 JESDUVROQ 2MG TABLET / ORAL RLD 2023-02-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216951-003 JESDUVROQ 4MG TABLET / ORAL RLD 2023-02-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216951-004 JESDUVROQ 6MG TABLET / ORAL RLD 2023-02-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216951-005 JESDUVROQ 8MG TABLET / ORAL RLD 2023-02-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216951-001 JESDUVROQ 1MG TABLET / ORAL RLD 2023-02-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216951-002 JESDUVROQ 2MG TABLET / ORAL RLD 2023-02-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216951-003 JESDUVROQ 4MG TABLET / ORAL RLD 2023-02-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216951-004 JESDUVROQ 6MG TABLET / ORAL RLD 2023-02-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216951-005 JESDUVROQ 8MG TABLET / ORAL RLD 2023-02-01 5bbf6a4d5a75…
Observed Orange Book patent history# Patent history page 1 of 17 · 680 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N216951-001 11643397 2027-06-22 U-3535 Drug substance 2023-06-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216951-001 8557834 2027-06-22 U-1238 2023-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216951-001 8815884 2027-06-22 U-1238 Drug product 2023-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216951-001 8324208 2028-12-11 Drug substance, Drug product 2023-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216951-001 11117871 2038-03-13 U-3535 Drug substance, Drug product 2023-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216951-001 11649217 2038-03-13 U-3535 Drug product 2023-06-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216951-002 11643397 2027-06-22 U-3535 Drug substance 2023-06-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216951-002 8557834 2027-06-22 U-1238 2023-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216951-002 8815884 2027-06-22 U-1238 Drug product 2023-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216951-002 8324208 2028-12-11 Drug substance, Drug product 2023-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216951-002 11117871 2038-03-13 U-3535 Drug substance, Drug product 2023-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216951-002 11649217 2038-03-13 U-3535 Drug product 2023-06-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216951-003 11643397 2027-06-22 U-3535 Drug substance 2023-06-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216951-003 8557834 2027-06-22 U-1238 2023-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216951-003 8815884 2027-06-22 U-1238 Drug product 2023-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216951-003 8324208 2028-12-11 Drug substance, Drug product 2023-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216951-003 11117871 2038-03-13 U-3535 Drug substance, Drug product 2023-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216951-003 11649217 2038-03-13 U-3535 Drug product 2023-06-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216951-004 11643397 2027-06-22 U-3535 Drug substance 2023-06-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216951-004 8557834 2027-06-22 U-1238 2023-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216951-004 8815884 2027-06-22 U-1238 Drug product 2023-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216951-004 8324208 2028-12-11 Drug substance, Drug product 2023-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216951-004 11117871 2038-03-13 U-3535 Drug substance, Drug product 2023-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216951-004 11649217 2038-03-13 U-3535 Drug product 2023-06-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216951-005 11643397 2027-06-22 U-3535 Drug substance 2023-06-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216951-005 8557834 2027-06-22 U-1238 2023-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216951-005 8815884 2027-06-22 U-1238 Drug product 2023-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216951-005 8324208 2028-12-11 Drug substance, Drug product 2023-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216951-005 11117871 2038-03-13 U-3535 Drug substance, Drug product 2023-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216951-005 11649217 2038-03-13 U-3535 Drug product 2023-06-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216951-001 11643397 2027-06-22 U-3535 Drug substance 2023-06-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216951-001 8557834 2027-06-22 U-1238 2023-02-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216951-001 8815884 2027-06-22 U-1238 Drug product 2023-02-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216951-001 8324208 2028-12-11 Drug substance, Drug product 2023-02-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216951-001 11117871 2038-03-13 U-3535 Drug substance, Drug product 2023-02-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216951-001 11649217 2038-03-13 U-3535 Drug product 2023-06-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216951-002 11643397 2027-06-22 U-3535 Drug substance 2023-06-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216951-002 8557834 2027-06-22 U-1238 2023-02-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216951-002 8815884 2027-06-22 U-1238 Drug product 2023-02-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216951-002 8324208 2028-12-11 Drug substance, Drug product 2023-02-21 31067a03dcf5…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 115 observed states.
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 Jesduvroq DAPRODUSTAT GlaxoSmithKline LLC d82aa06e-5a33-4844-99b7-4701313455a4 2023-08-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 216951 application number: NDA216951
Documents# Document, Submission type, Date table Document Submission type Date 73675 ORIG 2023-03-06 73371 ORIG 2023-02-02 73369 ORIG 2023-02-02 73368 ORIG 2023-02-02