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 4 of 7 · 127 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Kirkland Signature Aller FloFLUTICASONE PROPIONATECostco Wholesale Companybf120a48-cc29-4f40-b70d-415868ac9d3e2026-01-06WarningsName fallback
generic name: FLUTICASONE PROPIONATE
Allergy ReliefFLUTICASONE PROPIONATEMeijer Distribution Incb69241d8-f019-43fe-b12b-25edcf01df402025-12-12WarningsName fallback
generic name: FLUTICASONE PROPIONATE
CHILDRENS FLUTICASONE PROPIONATEFLUTICASONE PROPIONATEAurohealth LLC180ef101-dca6-496f-8376-63449d82d0832025-12-08WarningsName fallback
generic name: FLUTICASONE PROPIONATE
FLUTICASONE PROPIONATEFLUTICASONE PROPIONATEAurohealth LLC044a06a1-74fc-43ff-b136-37ad412209412025-12-08WarningsName fallback
generic name: FLUTICASONE PROPIONATE
basic care allergy relief nasalFLUTICASONE PROPIONATEAmazon.com Services LLC6e0628f6-bfdc-4c9d-8800-ffcdb93459f12025-11-25WarningsName fallback
generic name: FLUTICASONE PROPIONATE
Fluticasone PropionateFLUTICASONE PROPIONATEGolden State Medical Supply, Inc.db857d81-4b1e-42b8-972a-5bb8735d60f82025-11-24Warnings, Adverse reactionsName fallback
generic name: FLUTICASONE PROPIONATE
Equaline Fluticasone PropionateFLUTICASONE PROPIONATEUnited Natural Foods, Inc. dba UNFIdbaa5264-bbc9-411c-89bb-4aef3ee964592025-11-16WarningsName fallback
generic name: FLUTICASONE PROPIONATE
Fluticasone PropionateFLUTICASONE PROPIONATEBryant Ranch Prepack0cd0b88c-1ab3-4699-8eda-554054b8d33c2025-10-30Adverse reactionsName fallback
generic name: FLUTICASONE PROPIONATE
Fluticasone PropionateFLUTICASONE PROPIONATEEncube Ethicals, Inc.b734d397-e064-4d13-b0b5-fc89bd87f2e32025-10-27Adverse reactionsName fallback
generic name: FLUTICASONE PROPIONATE
Fluticasone PropionateFLUTICASONE PROPIONATESam's West, Incd2a6e22c-1159-c86a-b927-e7ace1d7023f2025-10-24WarningsName fallback
generic name: FLUTICASONE PROPIONATE
Fluticasone PropionateFLUTICASONE PROPIONATEHikma Pharmaceuticals USA Inc.0d9a521b-8314-437c-8c9f-f6188f1134fe2025-10-01Warnings, Adverse reactionsName fallback
generic name: FLUTICASONE PROPIONATE
Fluticasone PropionateFLUTICASONE PROPIONATEBryant Ranch Prepack36c0e343-5bd4-447e-8651-c5f44d2ffd7c2025-09-24Adverse reactionsName fallback
generic name: FLUTICASONE PROPIONATE
Childrens NasoproFLUTICASONE PROPIONATEH E B607d0a22-72d1-440f-9dac-e088b68dde092025-08-11WarningsName fallback
generic name: FLUTICASONE PROPIONATE
FLUTICAREFLUTICASONE PROPIONATEINNOVUS PHARMACEUTICALS, INC.fed545ab-6a85-4ce3-8651-370e279db49e2025-07-16WarningsName fallback
generic name: FLUTICASONE PROPIONATE
FLUTICASONE PROPIONATEFLUTICASONE PROPIONATEE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.0e20d1cc-5c7a-4e0d-810b-b94c4d6dd1c02025-07-08Adverse reactionsName fallback
generic name: FLUTICASONE PROPIONATE
Fluticasone PropionateFLUTICASONE PROPIONATEWalmart8616944c-a684-085a-7106-cf034e3f6f4d2025-07-01WarningsName fallback
generic name: FLUTICASONE PROPIONATE
DG Health childrens allergy relief nasalFLUTICASONE PROPIONATEDolgencorp Inc4dc4b47a-233c-4bb8-b08b-c07561c415ff2025-06-03WarningsName fallback
generic name: FLUTICASONE PROPIONATE
basic care childrens allergy relief nasalFLUTICASONE PROPIONATEAmazon.com Services LLCcb4cb80a-9bc5-4e7b-a33b-fb462abf96c52025-05-23WarningsName fallback
generic name: FLUTICASONE PROPIONATE
Fluticasone PropionateFLUTICASONE PROPIONATEBi-Mart3e4ff2eb-0d99-4ce7-910e-81f878b2231e2025-05-22WarningsName fallback
generic name: FLUTICASONE PROPIONATE
Fluticasone PropionateFLUTICASONE PROPIONATETWIN MED LLC9337aa4b-382d-4ab9-b312-60417cdd40cf2025-05-01WarningsName 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