FDA.reportPublic FDA data

Application 205625

Type
NDA
Sponsor
GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ARNUITY ELLIPTAFLUTICASONE FUROATEPOWDER;INHALATION0.1MG/INHYesYes
002ARNUITY ELLIPTAFLUTICASONE FUROATEPOWDER;INHALATION0.2MG/INHYesYes
003ARNUITY ELLIPTAFLUTICASONE FUROATEPOWDER;INHALATION0.05MG/INHYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N205625-001ARNUITY ELLIPTAFLUTICASONE FUROATE0.1MG/INHPOWDER / INHALATIONRLD, RS2014-08-20
N205625-002ARNUITY ELLIPTAFLUTICASONE FUROATE0.2MG/INHPOWDER / INHALATIONRLD, RS2014-08-20
N205625-003ARNUITY ELLIPTAFLUTICASONE FUROATE0.05MG/INHPOWDER / INHALATIONRLD, RS2018-05-17

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 1 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N205625-003M-2902026-03-01

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N205625-001ARNUITY ELLIPTA0.1MG/INHPOWDER / INHALATIONRLD, RS2014-08-20a50c72e98297…
2026-08-01 22:54:322026-06N205625-002ARNUITY ELLIPTA0.2MG/INHPOWDER / INHALATIONRLD, RS2014-08-20a50c72e98297…
2026-08-01 22:54:322026-06N205625-003ARNUITY ELLIPTA0.05MG/INHPOWDER / INHALATIONRLD, RS2018-05-17a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-08-01 22:54:322026-06N205625-003M-2902026-03-01a50c72e98297…

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fluticasone Furoate ElliptaFLUTICASONE FUROATEPrasco Laboratoriesd3e797fc-2636-49a0-b89e-5246b18ee4402025-03-06Warnings, Adverse reactionsExact identifier
application applno (NDA): 205625
application number: NDA205625
Arnuity ElliptaFLUTICASONE FUROATEGlaxoSmithKline LLC50f193ee-1691-486d-9370-a664df63695c2023-10-18Warnings, Adverse reactionsExact identifier
application applno (NDA): 205625
application number: NDA205625
ndc (product): 0173-0874
ndc (product): 0173-0876
ndc (product): 0173-0888

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0173-0874Arnuity Elliptafluticasone furoateGlaxoSmithKline LLCNDACurrent
0173-0874Arnuity Elliptafluticasone furoateGlaxoSmithKline LLCNDACurrent
0173-0874Arnuity Elliptafluticasone furoateGlaxoSmithKline LLCNDACurrent
0173-0874Arnuity Elliptafluticasone furoateGlaxoSmithKline LLCNDACurrent
0173-0874Arnuity Elliptafluticasone furoateGlaxoSmithKline LLCNDACurrent
0173-0876Arnuity Elliptafluticasone furoateGlaxoSmithKline LLCNDACurrent
0173-0876Arnuity Elliptafluticasone furoateGlaxoSmithKline LLCNDACurrent
0173-0876Arnuity Elliptafluticasone furoateGlaxoSmithKline LLCNDACurrent
0173-0876Arnuity Elliptafluticasone furoateGlaxoSmithKline LLCNDACurrent
0173-0876Arnuity Elliptafluticasone furoateGlaxoSmithKline LLCNDACurrent
0173-0888Arnuity Elliptafluticasone furoateGlaxoSmithKline LLCNDACurrent
0173-0888Arnuity Elliptafluticasone furoateGlaxoSmithKline LLCNDACurrent
0173-0888Arnuity Elliptafluticasone furoateGlaxoSmithKline LLCNDACurrent
0173-0888Arnuity Elliptafluticasone furoateGlaxoSmithKline LLCNDACurrent
0173-0888Arnuity Elliptafluticasone furoateGlaxoSmithKline LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
75863SUPPL 2023-10-19
75845SUPPL 2023-10-19
73656SUPPL 2023-03-02
73652SUPPL 2023-03-02
57541SUPPL2019-02-13
57128SUPPL2019-01-08
54267SUPPL2018-05-21
54260SUPPL2018-05-21
44927ORIG2015-10-07
43496ORIG2015-10-07
40486SUPPL2015-03-24
10479SUPPL2015-03-24
19668ORIG2014-08-22
10478ORIG2014-08-21
51112ORIG1900-01-01
51111ORIG1900-01-01
51110ORIG1900-01-01