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 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 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.
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 2026-08-01 22:54:32 2026-06 N208169-001 XURIDEN 2GM/PACKET GRANULE / ORAL RLD, RS 2015-09-04 a50c72e98297…
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.
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