Home Applications 214018 Application 214018
Type NDA
Sponsor ORIGIN BIOSCIENCES INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 NULIBRY FOSDENOPTERIN INJECTABLE;INJECTION 9.5MG Yes 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 N214018-001 NULIBRY FOSDENOPTERIN HYDROBROMIDE EQ 9.5MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-26
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N214018-001 7504095 2029-04-09 U-3092 Drug product 2021-03-23
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N214018-001 NCE 2026-02-26 N214018-001 ODE-342 2028-02-26
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 2026-02-19 14:30 UTC 2026-02 N214018-001 NULIBRY EQ 9.5MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214018-001 NULIBRY EQ 9.5MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214018-001 NULIBRY EQ 9.5MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214018-001 NULIBRY EQ 9.5MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214018-001 NULIBRY EQ 9.5MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214018-001 NULIBRY EQ 9.5MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214018-001 NULIBRY EQ 9.5MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214018-001 NULIBRY EQ 9.5MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214018-001 NULIBRY EQ 9.5MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N214018-001 NULIBRY EQ 9.5MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214018-001 NULIBRY EQ 9.5MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214018-001 NULIBRY EQ 9.5MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N214018-001 NULIBRY EQ 9.5MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N214018-001 NULIBRY EQ 9.5MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N214018-001 NULIBRY EQ 9.5MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N214018-001 NULIBRY EQ 9.5MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N214018-001 NULIBRY EQ 9.5MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-26 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N214018-001 NULIBRY EQ 9.5MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N214018-001 NULIBRY EQ 9.5MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N214018-001 NULIBRY EQ 9.5MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-26 87673890dc5c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N214018-001 NULIBRY EQ 9.5MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N214018-001 NULIBRY EQ 9.5MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N214018-001 NULIBRY EQ 9.5MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N214018-001 NULIBRY EQ 9.5MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N214018-001 NULIBRY EQ 9.5MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N214018-001 NULIBRY EQ 9.5MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N214018-001 NULIBRY EQ 9.5MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N214018-001 NULIBRY EQ 9.5MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N214018-001 NULIBRY EQ 9.5MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N214018-001 NULIBRY EQ 9.5MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N214018-001 NULIBRY EQ 9.5MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N214018-001 NULIBRY EQ 9.5MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-26 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N214018-001 NULIBRY EQ 9.5MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-26 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N214018-001 NULIBRY EQ 9.5MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2021-02-26 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 2026-02-19 14:30 UTC 2026-02 N214018-001 7504095 2029-04-09 U-3092 Drug product 2021-03-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214018-001 7504095 2029-04-09 U-3092 Drug product 2021-03-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214018-001 7504095 2025-01-31 U-3092 Drug product 2021-03-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214018-001 7504095 2025-01-31 U-3092 Drug product 2021-03-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214018-001 7504095 2025-01-31 U-3092 Drug product 2021-03-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214018-001 7504095 2025-01-31 U-3092 Drug product 2021-03-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214018-001 7504095 2025-01-31 U-3092 Drug product 2021-03-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214018-001 7504095 2025-01-31 U-3092 Drug product 2021-03-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214018-001 7504095 2025-01-31 U-3092 Drug product 2021-03-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N214018-001 7504095 2025-01-31 U-3092 Drug product 2021-03-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214018-001 7504095 2025-01-31 U-3092 Drug product 2021-03-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214018-001 7504095 2025-01-31 U-3092 Drug product 2021-03-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N214018-001 7504095 2025-01-31 U-3092 Drug product 2021-03-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N214018-001 7504095 2025-01-31 U-3092 Drug product 2021-03-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N214018-001 7504095 2025-01-31 U-3092 Drug product 2021-03-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N214018-001 7504095 2025-01-31 U-3092 Drug product 2021-03-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N214018-001 7504095 2025-01-31 U-3092 Drug product 2021-03-23 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N214018-001 7504095 2025-01-31 U-3092 Drug product 2021-03-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N214018-001 7504095 2025-01-31 U-3092 Drug product 2021-03-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N214018-001 7504095 2025-01-31 U-3092 Drug product 2021-03-23 87673890dc5c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N214018-001 7504095 2025-01-31 U-3092 Drug product 2021-03-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N214018-001 7504095 2025-01-31 U-3092 Drug product 2021-03-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N214018-001 7504095 2025-01-31 U-3092 Drug product 2021-03-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N214018-001 7504095 2025-01-31 U-3092 Drug product 2021-03-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N214018-001 7504095 2025-01-31 U-3092 Drug product 2021-03-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N214018-001 7504095 2025-01-31 U-3092 Drug product 2021-03-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N214018-001 7504095 2025-01-31 U-3092 Drug product 2021-03-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N214018-001 7504095 2025-01-31 U-3092 Drug product 2021-03-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N214018-001 7504095 2025-01-31 U-3092 Drug product 2021-03-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N214018-001 7504095 2025-01-31 U-3092 Drug product 2021-03-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N214018-001 7504095 2025-01-31 U-3092 Drug product 2021-03-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N214018-001 7504095 2025-01-31 U-3092 Drug product 2021-03-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N214018-001 7504095 2025-01-31 U-3092 Drug product 2021-03-23 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N214018-001 7504095 2029-04-09 U-3092 Drug product 2021-03-23 a50c72e98297…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 88 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 Nulibry FOSDENOPTERIN HYDROBROMIDE Sentynl Therapeutics, Inc. 736aeea3-f206-454d-95d0-fd30964e8aab 2026-05-26 Warnings, Adverse reactions Exact identifier application applno (NDA): 214018 application number: NDA214018
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 2 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 73129-001 Nulibry fosdenopterin hydrobromide Origin Biosciences, Inc. NDA Current 73129-001 Nulibry fosdenopterin hydrobromide Origin Biosciences, Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 72526 SUPPL 2022-11-01 72492 SUPPL 2022-10-28 66883 ORIG 2021-03-26 66416 ORIG 2021-03-01 66410 ORIG 2021-02-26