FDA.reportPublic FDA data

Application 020549

Type
NDA
Sponsor
GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLOVENTFLUTICASONE PROPIONATEPOWDER;INHALATION0.044MG/INHNoNo
002FLOVENTFLUTICASONE PROPIONATEPOWDER;INHALATION0.088MG/INHNoNo
003FLOVENTFLUTICASONE PROPIONATEPOWDER;INHALATION0.22MG/INHNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N020549-001FLOVENTFLUTICASONE PROPIONATE0.044MG/INHPOWDER / INHALATION1997-11-07
N020549-002FLOVENTFLUTICASONE PROPIONATE0.088MG/INHPOWDER / INHALATION1997-11-07
N020549-003FLOVENTFLUTICASONE PROPIONATE0.22MG/INHPOWDER / INHALATION1997-11-07

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 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N020549-001FLOVENT0.044MG/INHPOWDER / INHALATION1997-11-0784e616aacf4f…
2026-09-14 22:38:342026-08N020549-002FLOVENT0.088MG/INHPOWDER / INHALATION1997-11-0784e616aacf4f…
2026-09-14 22:38:342026-08N020549-003FLOVENT0.22MG/INHPOWDER / INHALATION1997-11-0784e616aacf4f…
2026-08-18 06:07:402026-07N020549-001FLOVENT0.044MG/INHPOWDER / INHALATION1997-11-07caaa826d4ba7…
2026-08-18 06:07:402026-07N020549-002FLOVENT0.088MG/INHPOWDER / INHALATION1997-11-07caaa826d4ba7…
2026-08-18 06:07:402026-07N020549-003FLOVENT0.22MG/INHPOWDER / INHALATION1997-11-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020549-001FLOVENT0.044MG/INHPOWDER / INHALATION1997-11-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020549-002FLOVENT0.088MG/INHPOWDER / INHALATION1997-11-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020549-003FLOVENT0.22MG/INHPOWDER / INHALATION1997-11-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020549-001FLOVENT0.044MG/INHPOWDER / INHALATION1997-11-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020549-002FLOVENT0.088MG/INHPOWDER / INHALATION1997-11-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020549-003FLOVENT0.22MG/INHPOWDER / INHALATION1997-11-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08N020549-001FLOVENT0.044MG/INHPOWDER / INHALATION1997-11-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020549-002FLOVENT0.088MG/INHPOWDER / INHALATION1997-11-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020549-003FLOVENT0.22MG/INHPOWDER / INHALATION1997-11-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020549-001FLOVENT0.044MG/INHPOWDER / INHALATION1997-11-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020549-002FLOVENT0.088MG/INHPOWDER / INHALATION1997-11-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020549-003FLOVENT0.22MG/INHPOWDER / INHALATION1997-11-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020549-001FLOVENT0.044MG/INHPOWDER / INHALATION1997-11-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020549-002FLOVENT0.088MG/INHPOWDER / INHALATION1997-11-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020549-003FLOVENT0.22MG/INHPOWDER / INHALATION1997-11-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020549-001FLOVENT0.044MG/INHPOWDER / INHALATION1997-11-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020549-002FLOVENT0.088MG/INHPOWDER / INHALATION1997-11-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020549-003FLOVENT0.22MG/INHPOWDER / INHALATION1997-11-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020549-001FLOVENT0.044MG/INHPOWDER / INHALATION1997-11-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020549-002FLOVENT0.088MG/INHPOWDER / INHALATION1997-11-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020549-003FLOVENT0.22MG/INHPOWDER / INHALATION1997-11-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020549-001FLOVENT0.044MG/INHPOWDER / INHALATION1997-11-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020549-002FLOVENT0.088MG/INHPOWDER / INHALATION1997-11-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020549-003FLOVENT0.22MG/INHPOWDER / INHALATION1997-11-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020549-001FLOVENT0.044MG/INHPOWDER / INHALATION1997-11-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020549-002FLOVENT0.088MG/INHPOWDER / INHALATION1997-11-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020549-003FLOVENT0.22MG/INHPOWDER / INHALATION1997-11-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020549-001FLOVENT0.044MG/INHPOWDER / INHALATION1997-11-07d06236e962d9…
2024-10-29 15:01 UTC2024-10N020549-002FLOVENT0.088MG/INHPOWDER / INHALATION1997-11-07d06236e962d9…
2024-10-29 15:01 UTC2024-10N020549-003FLOVENT0.22MG/INHPOWDER / INHALATION1997-11-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020549-001FLOVENT0.044MG/INHPOWDER / INHALATION1997-11-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020549-002FLOVENT0.088MG/INHPOWDER / INHALATION1997-11-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020549-003FLOVENT0.22MG/INHPOWDER / INHALATION1997-11-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020549-001FLOVENT0.044MG/INHPOWDER / INHALATION1997-11-07301d65b070ca…

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 3 of 7 · 127 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nasopro 24FLUTICASONE PROPIONATEH E B8416eb8f-e7fc-4cae-9aa1-84b2321ad67e2026-03-10WarningsName fallback
generic name: FLUTICASONE PROPIONATE
Fluticasone PropionateFLUTICASONE PROPIONATEApotex Corp.e3c861e3-2507-9758-fcd0-8e82d721b5b42026-03-06WarningsName fallback
generic name: FLUTICASONE PROPIONATE
RUGBY FLUTICASONE PROPIONATE NASALFLUTICASONE PROPIONATEA-S Medication Solutions0c4eb6cb-abc9-4945-8f30-cfa8b9eb579c2026-02-24WarningsName fallback
generic name: FLUTICASONE PROPIONATE
Topcare Allergy Relief NasalFLUTICASONE PROPIONATETopco Associates LLC4586256c-cc86-4792-92ef-5a65a35d63772026-02-19WarningsName fallback
generic name: FLUTICASONE PROPIONATE
ALLERGY RELIEFFLUTICASONE PROPIONATECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED1a4f4449-a8d3-4c5b-8ba1-21223574545b2026-02-17WarningsName fallback
generic name: FLUTICASONE PROPIONATE
RUGBY FLUTICASONE PROPIONATE NASALFLUTICASONE PROPIONATEASCLEMED USA INC.e38d8796-b08c-49a8-94b8-0c2fdeb52a812026-02-10WarningsName fallback
generic name: FLUTICASONE PROPIONATE
exchange select allergy reliefFLUTICASONE PROPIONATEArmy & Air Force Exchange Servicef15d5c04-e308-4540-8c0a-d66a44c3d4fd2026-02-10WarningsName fallback
generic name: FLUTICASONE PROPIONATE
RUGBY FLUTICASONE PROPIONATE NASALFLUTICASONE PROPIONATESportpharm LLC95765842-415e-438b-8105-f6d93cddbdd02026-02-09WarningsName fallback
generic name: FLUTICASONE PROPIONATE
24 Hour Allergy NasalFLUTICASONE PROPIONATEWalgreen Company7698b73f-16f4-4b99-a3be-9453e8c354692026-02-05WarningsName fallback
generic name: FLUTICASONE PROPIONATE
FLUTICASONE PROPIONATEFLUTICASONE PROPIONATEAdvagen Pharma Ltd2c1c465c-d008-470e-aa48-8b44bd60751c2026-02-04Warnings, Adverse reactionsName fallback
generic name: FLUTICASONE PROPIONATE
365 WHOLE FOODS MARKET FLUTICASONE PROPIONATEFLUTICASONE PROPIONATEWhole Foods Market, Inc.313517bd-cb08-49a5-8ef1-e5522cc21c802026-01-22WarningsName fallback
generic name: FLUTICASONE PROPIONATE
leader fluticasone propionateFLUTICASONE PROPIONATECardinal Health 110, LLC. dba Leader14bb5d74-0384-417e-a06b-8868d85234dd2026-01-21WarningsName fallback
generic name: FLUTICASONE PROPIONATE
DG Health Allergy Relief NasalFLUTICASONE PROPIONATEDolgencorp Inc5f0514bd-7893-4602-a17b-716fb99475722026-01-21WarningsName fallback
generic name: FLUTICASONE PROPIONATE
Foster and Thrive Allergy ReliefFLUTICASONE PROPIONATEStrategic Sourcing Services LLC67899c15-e5e5-4fe6-a639-71832969a7612026-01-21WarningsName fallback
generic name: FLUTICASONE PROPIONATE
Fluticasone Propionate HFAFLUTICASONE PROPIONATEPreferred Pharmaceuticals Inc.ff1cf174-ae6f-45f0-a081-26a34e55f9ea2026-01-20Warnings, Adverse reactionsName fallback
generic name: FLUTICASONE PROPIONATE
FLUTICASONE PROPIONATEFLUTICASONE PROPIONATENuCare Pharmaceuticals, Inc.4849c4e5-58ea-972c-e063-6394a90a809c2026-01-13Warnings, Adverse reactionsName fallback
generic name: FLUTICASONE PROPIONATE
XHANCEFLUTICASONE PROPIONATEOptiNose US, Inc.c79bbb9f-e483-4093-8c92-ea978e7bf2782026-01-12Warnings, Adverse reactionsName fallback
generic name: FLUTICASONE PROPIONATE
allergy relief nasalFLUTICASONE PROPIONATEPublix Super Markets Inca70e26c8-2f50-49ac-8278-fc06e4c63e6a2026-01-08WarningsName fallback
generic name: FLUTICASONE PROPIONATE
RUGBY FLUTICASONE PROPIONATE NASALFLUTICASONE PROPIONATERugby Laboratories5227df05-f2c2-4bc4-91ee-da0fd03d10952026-01-08WarningsName fallback
generic name: FLUTICASONE PROPIONATE
good neighbor pharmacy fluticasone propionateFLUTICASONE PROPIONATEAmerisource Bergenb12ddc59-b689-48ac-9a40-2b9ae04a13122026-01-08WarningsName fallback
generic name: FLUTICASONE PROPIONATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
20714SUPPL2004-06-04
2705SUPPL2004-04-07
34812SUPPL2004-04-05
25155SUPPL2003-10-16
12712SUPPL2003-10-16
34811SUPPL2003-07-08
2704SUPPL2003-07-06
41424SUPPL1999-07-19
41423SUPPL1998-12-22
41422ORIG1997-11-07