Home Applications 220295 Application 220295
Type NDA
Sponsor GLAXOSMITHKLINE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LYNAVOY LINERIXIBAT TABLET;ORAL 40MG 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 N220295-001 LYNAVOY LINERIXIBAT 40MG TABLET / ORAL RLD, RS 2026-03-17
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 N220295-001 9040518 2031-09-06 Drug substance, Drug product 2026-04-06
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N220295-001 NCE 2031-03-17 N220295-001 ODE-517 2033-03-17
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 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N220295-001 LYNAVOY 40MG TABLET / ORAL RLD, RS 2026-03-17 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 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N220295-001 9040518 2031-09-06 Drug substance, Drug product 2026-04-06 a50c72e98297…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N220295-001 NCE 2031-03-17 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N220295-001 ODE-517 2033-03-17 a50c72e98297…
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 Lynavoy LINERIXIBAT Intercept Pharmaceuticals Inc c00317c8-709c-4707-a6d1-632bff123026 2026-07-29 Warnings, Adverse reactions Exact identifier application applno (NDA): 220295 application number: NDA220295
Documents# Document, Submission type, Date table Document Submission type Date 85895 ORIG 2026-05-13 85477 ORIG 2026-03-24 85397 ORIG 2026-03-19