FDA.reportPublic FDA data

Application 020784

Type
NDA
Sponsor
SANOFI AVENTIS US

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NASACORT HFATRIAMCINOLONE ACETONIDESPRAY, METERED;NASAL0.055MG/SPRAYNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N020784-001NASACORT HFATRIAMCINOLONE ACETONIDE0.055MG/SPRAYSPRAY, METERED / NASAL2004-04-07

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 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09N020784-001NASACORT HFA0.055MG/SPRAYSPRAY, METERED / NASAL2004-04-07c2088c7a36db…
2026-09-14 22:38:342026-08N020784-001NASACORT HFA0.055MG/SPRAYSPRAY, METERED / NASAL2004-04-0784e616aacf4f…
2026-08-18 06:07:402026-07N020784-001NASACORT HFA0.055MG/SPRAYSPRAY, METERED / NASAL2004-04-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020784-001NASACORT HFA0.055MG/SPRAYSPRAY, METERED / NASAL2004-04-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020784-001NASACORT HFA0.055MG/SPRAYSPRAY, METERED / NASAL2004-04-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08N020784-001NASACORT HFA0.055MG/SPRAYSPRAY, METERED / NASAL2004-04-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020784-001NASACORT HFA0.055MG/SPRAYSPRAY, METERED / NASAL2004-04-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020784-001NASACORT HFA0.055MG/SPRAYSPRAY, METERED / NASAL2004-04-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020784-001NASACORT HFA0.055MG/SPRAYSPRAY, METERED / NASAL2004-04-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020784-001NASACORT HFA0.055MG/SPRAYSPRAY, METERED / NASAL2004-04-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020784-001NASACORT HFA0.055MG/SPRAYSPRAY, METERED / NASAL2004-04-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020784-001NASACORT HFA0.055MG/SPRAYSPRAY, METERED / NASAL2004-04-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020784-001NASACORT HFA0.055MG/SPRAYSPRAY, METERED / NASAL2004-04-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020784-001NASACORT HFA0.055MG/SPRAYSPRAY, METERED / NASAL2004-04-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020784-001NASACORT HFA0.055MG/SPRAYSPRAY, METERED / NASAL2004-04-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020784-001NASACORT HFA0.055MG/SPRAYSPRAY, METERED / NASAL2004-04-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020784-001NASACORT HFA0.055MG/SPRAYSPRAY, METERED / NASAL2004-04-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020784-001NASACORT HFA0.055MG/SPRAYSPRAY, METERED / NASAL2004-04-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020784-001NASACORT HFA0.055MG/SPRAYSPRAY, METERED / NASAL2004-04-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020784-001NASACORT HFA0.055MG/SPRAYSPRAY, METERED / NASAL2004-04-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020784-001NASACORT HFA0.055MG/SPRAYSPRAY, METERED / NASAL2004-04-0774a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020784-001NASACORT HFA0.055MG/SPRAYSPRAY, METERED / NASAL2004-04-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020784-001NASACORT HFA0.055MG/SPRAYSPRAY, METERED / NASAL2004-04-07782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020784-001NASACORT HFA0.055MG/SPRAYSPRAY, METERED / NASAL2004-04-0787673890dc5c…
2021-03-12 10:30 UTC2021-03N020784-001NASACORT HFA0.055MG/SPRAYSPRAY, METERED / NASAL2004-04-075aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020784-001NASACORT HFA0.055MG/SPRAYSPRAY, METERED / NASAL2004-04-078869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020784-001NASACORT HFA0.055MG/SPRAYSPRAY, METERED / NASAL2004-04-07c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020784-001NASACORT HFA0.055MG/SPRAYSPRAY, METERED / NASAL2004-04-073f01610625f2…
2019-09-15 20:21 UTC2019-09N020784-001NASACORT HFA0.055MG/SPRAYSPRAY, METERED / NASAL2004-04-07b00525d2431f…
2019-07-19 19:46 UTC2019-07N020784-001NASACORT HFA0.055MG/SPRAYSPRAY, METERED / NASAL2004-04-07ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020784-001NASACORT HFA0.055MG/SPRAYSPRAY, METERED / NASAL2004-04-076a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020784-001NASACORT HFA0.055MG/SPRAYSPRAY, METERED / NASAL2004-04-071c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020784-001NASACORT HFA0.055MG/SPRAYSPRAY, METERED / NASAL2004-04-07ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020784-001NASACORT HFA0.055MG/SPRAYSPRAY, METERED / NASAL2004-04-07a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020784-001NASACORT HFA0.055MG/SPRAYSPRAY, METERED / NASAL2004-04-079b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020784-001NASACORT HFA0.055MG/SPRAYSPRAY, METERED / NASAL2004-04-07a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020784-001NASACORT HFA0.055MG/SPRAYSPRAY, METERED / NASAL2004-04-073f0d92c62455…
2023-05-13 08:27 UTC2023-05N020784-001NASACORT HFA0.055MG/SPRAYSPRAY, METERED / NASAL2004-04-07053a50430f4f…
2023-01-26 05:58 UTC2023-01N020784-001NASACORT HFA0.055MG/SPRAYSPRAY, METERED / NASAL2004-04-073bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020784-001NASACORT HFA0.055MG/SPRAYSPRAY, METERED / NASAL2004-04-073a93d1ddd44b…

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 8 of 10 · 199 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEProficient Rx LP64d6a2f3-18cc-4ce4-8e75-4d77515e19112024-03-01Adverse reactionsName fallback
generic name: TRIAMCINOLONE ACETONIDE
TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEA-S Medication Solutions7889440c-4e82-4eb2-b5d3-7c4e0d5bdd8d2024-02-20Adverse reactionsName fallback
generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEProficient Rx LPde5bad69-a014-4e25-b1b9-214373ca57a52024-02-01Adverse reactionsName fallback
generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEBryant Ranch Prepackee274346-938b-4678-9146-486ca65bcba52024-01-15Adverse reactionsName fallback
generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEBryant Ranch Prepack1e9007e8-fcd4-4aff-8d0a-4a43e0b8e6732024-01-12Adverse reactionsName fallback
generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEBryant Ranch Prepack2adb56d4-2883-4060-b8cb-65a7662cfdda2024-01-12Adverse reactionsName fallback
generic name: TRIAMCINOLONE ACETONIDE
Triloan II SUIKTRIAMCINOLONE ACETONIDEAsclemed USA, Inc.af3d002d-5e8e-44f6-bdd9-45a99263221b2024-01-09Warnings, Adverse reactionsName fallback
generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone acetonideTRIAMCINOLONE ACETONIDEA-S Medication Solutionsb3d21abc-8952-45c3-b8cf-efa4dcce268d2023-12-28Adverse reactionsName fallback
generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDENorthStar RxLLCcc60731e-6cef-44b1-903c-13c6f4a76e702023-12-25Adverse reactionsName fallback
generic name: TRIAMCINOLONE ACETONIDE
triamcinolone acetonideTRIAMCINOLONE ACETONIDEA-S Medication Solutions2d6b9c2f-f1a0-413e-b333-64da523682022023-12-09Adverse reactionsName fallback
generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEProficient Rx LP1bc85267-249f-4c55-9a8a-06d265263cb52023-12-01Adverse reactionsName fallback
generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEBryant Ranch Prepack72038652-b15a-4a84-bccc-d50731ac5f032023-11-01Adverse reactionsName fallback
generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEA-S Medication Solutionsb6beaa63-5bd8-4936-8611-ba23893880272023-10-31Adverse reactionsName fallback
generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone acetonideTRIAMCINOLONE ACETONIDEBryant Ranch Prepackad88de0e-6e01-4056-b259-841fb67d2db02023-10-30Adverse reactionsName fallback
generic name: TRIAMCINOLONE ACETONIDE
Topcare Nasal AllergyTRIAMCINOLONE ACETONIDETopco Associates LLCed8eaf1d-babc-47e1-930b-676ccfbf0de92023-10-10WarningsName fallback
generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEPadagis Israel Pharmaceuticals Ltd838ba2fa-5133-4975-bd99-791891a144c52023-10-01Adverse reactionsName fallback
generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone acetonideTRIAMCINOLONE ACETONIDEProficient Rx LP6bb0edc7-643b-4b20-aa48-ee3b22bce5752023-10-01Adverse reactionsName fallback
generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone acetonideTRIAMCINOLONE ACETONIDEMacleods Pharmaceuticals Limited43481ee3-0419-44c9-93ab-4fab9baa92732023-08-21Adverse reactionsName fallback
generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone acetonideTRIAMCINOLONE ACETONIDEBryant Ranch Prepack70116d71-97a9-4a9b-bf1d-e79c8ef596e22023-08-04Adverse reactionsName fallback
generic name: TRIAMCINOLONE ACETONIDE
Equaline nasal allergyTRIAMCINOLONE ACETONIDEUnited Natural Foods, Inc. dba UNFI6efd653e-82ee-43a5-9544-699f2cfabe9d2023-08-01WarningsName fallback
generic name: TRIAMCINOLONE ACETONIDE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
41699ORIG2007-07-03
25824ORIG2004-04-20