Home Applications 208169 Application 208169
Type NDA
Sponsor WELLSTAT THERAP Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 XURIDEN URIDINE TRIACETATE GRANULE;ORAL 2GM/PACKET Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N208169-001 XURIDEN URIDINE TRIACETATE 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04
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 2 · 42 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 2026-08-18 06:07:40 2026-07 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 e64feba35796…
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 2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208169-001 6258795 2023-07-10 Drug product 2015-10-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208169-001 6258795 2023-07-10 Drug product 2015-10-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208169-001 6258795 2023-07-10 Drug product 2015-10-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N208169-001 6258795 2023-07-10 Drug product 2015-10-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N208169-001 6258795 2023-07-10 Drug product 2015-10-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N208169-001 6258795 2023-07-10 Drug product 2015-10-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N208169-001 6258795 2023-07-10 Drug product 2015-10-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N208169-001 6258795 2023-07-10 Drug product 2015-10-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N208169-001 6258795 2023-07-10 Drug product 2015-10-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N208169-001 6258795 2023-07-10 Drug product 2015-10-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N208169-001 6258795 2023-07-10 Drug product 2015-10-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N208169-001 6258795 2023-07-10 Drug product 2015-10-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N208169-001 6258795 2023-07-10 Drug product 2015-10-22 ea99ee380514…2023-12-20 04:57 UTC 2023-12 N208169-001 6258795 2023-07-10 Drug product 2015-10-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N208169-001 6258795 2023-07-10 Drug product 2015-10-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N208169-001 6258795 2023-07-10 Drug product 2015-10-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N208169-001 6258795 2023-07-10 Drug product 2015-10-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N208169-001 6258795 2023-07-10 Drug product 2015-10-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N208169-001 6258795 2023-07-10 Drug product 2015-10-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N208169-001 6258795 2023-07-10 Drug product 2015-10-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N208169-001 6258795 2023-07-10 Drug product 2015-10-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N208169-001 6258795 2023-07-10 Drug product 2015-10-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N208169-001 6258795 2023-07-10 Drug product 2015-10-22 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N208169-001 6258795 2023-07-10 Drug product 2015-10-22 cb3db0bc1861…
Observed Orange Book exclusivity history# 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 XURIDEN URIDINE TRIACETATE BTG International Inc 88ca4d2b-3905-474b-9fd6-c81474f2fb4b 2025-02-18 Warnings, Adverse reactions Exact identifier application applno (NDA): 208169 application number: NDA208169
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 69468-152 XURIDEN uridine triacetate Wellstat Therapeutics Corporation NDA Current 69468-152 XURIDEN uridine triacetate Wellstat Therapeutics Corporation NDA Current 69468-152 XURIDEN uridine triacetate Wellstat Therapeutics Corporation NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 61152 SUPPL 2019-12-04 61127 SUPPL 2019-12-03 44972 ORIG 2015-10-08 23051 ORIG 2015-10-08 40621 ORIG 2015-09-22 10647 ORIG 2015-09-10