Application 208024

Type
ANDA
Sponsor
HI TECH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLUTICASONE PROPIONATEFLUTICASONE PROPIONATESPRAY, METERED;NASAL0.05MG/SPRAYNoNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A208024-001FLUTICASONE PROPIONATEFLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-17

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.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-17782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-1787673890dc5c…
2021-03-12 10:30 UTC2021-03A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-175aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-178869cabd3fbd…
2020-11-12 02:37 UTC2020-11A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-17c0c555d07b60…
2019-12-14 00:12 UTC2019-12A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-173f01610625f2…
2019-09-15 20:21 UTC2019-09A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-17b00525d2431f…
2019-07-19 19:46 UTC2019-07A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-17ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-176a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-171c564ffb4f44…
2023-12-20 04:57 UTC2023-12A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-17ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-17a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-179b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-17a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-173f0d92c62455…
2023-05-13 08:27 UTC2023-05A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-17053a50430f4f…
2023-01-26 05:58 UTC2023-01A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-173bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-173a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-17f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-17e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A208024-001FLUTICASONE PROPIONATE0.05MG/SPRAYSPRAY, METERED / NASAL2019-04-17cb3db0bc1861…

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 2 of 7 · 131 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CareOne Allergy ReliefFLUTICASONE PROPIONATEAmerican Sales Company587d7c72-a70e-4ada-945d-14989b96350c2026-04-23WarningsName fallback
generic name: FLUTICASONE PROPIONATE
careone childrens allergy reliefFLUTICASONE PROPIONATEAmerican Sales Company45ffaf45-8b88-44ba-804b-c2b5635898982026-04-23WarningsName fallback
generic name: FLUTICASONE PROPIONATE
Fluticasone PropionateFLUTICASONE PROPIONATEPreferred Pharmaceuticals Inc.0a3447a1-407c-40a8-99bb-7e9a86eb37df2026-04-22Warnings, Adverse reactionsName fallback
brand name: Fluticasone Propionate
generic name: FLUTICASONE PROPIONATE
Fluticasone PropionateFLUTICASONE PROPIONATEPreferred Pharmaceuticals, Inc.4916301d-bcc8-4cd1-86b4-7bf0aecfbf682026-04-22Warnings, Adverse reactionsName fallback
brand name: Fluticasone Propionate
generic name: FLUTICASONE PROPIONATE
Up and Up Allergy Relief NasalFLUTICASONE PROPIONATETarget Corporation51c0a953-93cb-4d0a-b51c-02d9482d17462026-04-20WarningsName fallback
generic name: FLUTICASONE PROPIONATE
Good Sense 24 hour allergy nasalFLUTICASONE PROPIONATEL. Perrigo Company783ce1b9-27e4-428a-9f5e-04e70b234ac92026-04-09WarningsName fallback
generic name: FLUTICASONE PROPIONATE
allergy reliefFLUTICASONE PROPIONATESafeway7b5547e1-af4d-4ba9-bd92-524aa11a0ecf2026-04-01WarningsName fallback
generic name: FLUTICASONE PROPIONATE
FLUTICASONE PROPIONATEFLUTICASONE PROPIONATEGlenmark Pharmaceuticals Inc., USA27a9b531-f0fd-44ee-b197-ac4b7d64b30c2026-03-25Warnings, Adverse reactionsName fallback
brand name: FLUTICASONE PROPIONATE
generic name: FLUTICASONE PROPIONATE
Fluticasone Propionate spray, meteredFLUTICASONE PROPIONATEChartwell RX, LLC71a2609f-c4b9-49b0-8185-83c20c22e1d62026-03-20Warnings, Adverse reactionsName fallback
generic name: FLUTICASONE PROPIONATE
Fluticasone PropionateFLUTICASONE PROPIONATEDirect_RX8b9f7474-8d89-b3e6-e053-2995a90aeddb2026-03-17Warnings, Adverse reactionsName fallback
brand name: Fluticasone Propionate
generic name: FLUTICASONE PROPIONATE
Fluticasone PropionateFLUTICASONE PROPIONATEGrocery Outlet838bbb29-0aa3-4c88-a10d-81be71c202112026-03-16WarningsName fallback
brand name: Fluticasone Propionate
generic name: FLUTICASONE PROPIONATE
Fluticasone PropionateFLUTICASONE PROPIONATEIPG Pharmaceuticals, Inc.f1965bd9-1851-4be5-bbe0-71dd59e034d52026-03-16Warnings, Adverse reactionsName fallback
brand name: Fluticasone Propionate
generic name: FLUTICASONE PROPIONATE
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
brand name: Fluticasone Propionate
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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0536-1373Allergy Relieffluticasone propionateRugby Laboratories, Inc.ANDACurrent
50383-968Fluticasone propionateFluticasone propionateHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-968Fluticasone propionateFluticasone propionateHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-968Fluticasone propionateFluticasone propionateAkornANDACurrent
50383-968Fluticasone propionateFluticasone propionateHi-Tech Pharmacal Co., Inc.ANDACurrent