Home Applications 203975 Application 203975
Type NDA
Sponsor GLAXOSMITHKLINE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ANORO ELLIPTA UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE POWDER;INHALATION EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH 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 N203975-001 ANORO ELLIPTA UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH POWDER / INHALATION RLD, RS 2013-12-18
Orange Book patents# Current patent rows page 1 of 1 · 6 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N203975-001 8511304 2027-06-14 U-1476 Drug product 2014-01-09 N203975-001 8511304*PED 2027-12-14 Pediatric extension N203975-001 7488827 2027-12-18 Drug substance, Drug product 2014-01-09 N203975-001 11090294 2030-11-29 U-3203 2021-09-14 N203975-001 12396986 2030-11-29 Drug product 2025-09-19 N203975-001 9750726 2030-11-29 Drug product 2017-09-21
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 N203975-001 ANORO ELLIPTA EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH POWDER / INHALATION RLD, RS 2013-12-18 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 2026-08-01 22:54:32 2026-06 N203975-001 8511304 2027-06-14 U-1476 Drug product 2014-01-09 a50c72e98297…2026-08-01 22:54:32 2026-06 N203975-001 8511304*PED 2027-12-14 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N203975-001 7488827 2027-12-18 Drug substance, Drug product 2014-01-09 a50c72e98297…2026-08-01 22:54:32 2026-06 N203975-001 11090294 2030-11-29 U-3203 2021-09-14 a50c72e98297…2026-08-01 22:54:32 2026-06 N203975-001 12396986 2030-11-29 Drug product 2025-09-19 a50c72e98297…2026-08-01 22:54:32 2026-06 N203975-001 9750726 2030-11-29 Drug product 2017-09-21 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 · 2 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 10 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0173-0869 Anoro Ellipta umeclidinium bromide and vilanterol trifenatate GlaxoSmithKline LLC NDA Current 0173-0869 Anoro Ellipta umeclidinium bromide and vilanterol trifenatate GlaxoSmithKline LLC NDA Current 0173-0869 Anoro Ellipta umeclidinium bromide and vilanterol trifenatate GlaxoSmithKline LLC NDA Current 0173-0869 Anoro Ellipta umeclidinium bromide and vilanterol trifenatate GlaxoSmithKline LLC NDA Current 0173-0869 Anoro Ellipta umeclidinium bromide and vilanterol trifenatate GlaxoSmithKline LLC NDA Current 0173-0869 Anoro Ellipta umeclidinium bromide and vilanterol trifenatate GlaxoSmithKline LLC NDA Current 0173-0869 Anoro Ellipta umeclidinium bromide and vilanterol trifenatate GlaxoSmithKline LLC NDA Current 0173-0869 Anoro Ellipta umeclidinium bromide and vilanterol trifenatate GlaxoSmithKline LLC NDA Current 0173-0869 Anoro Ellipta umeclidinium bromide and vilanterol trifenatate GlaxoSmithKline LLC NDA Current 0173-0869 Anoro Ellipta umeclidinium bromide and vilanterol trifenatate GlaxoSmithKline LLC NDA Current