Application 214615

Type
ANDA
Sponsor
APOTEX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
0010TRIAMCINOLONE ACETONIDESPRAY, METERED;NASAL0.055MG/SPRAYNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A214615-001TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDE0.055MG/SPRAYSPRAY, METERED / NASAL2023-01-19

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
2026-08-18 06:07:402026-07A214615-001TRIAMCINOLONE ACETONIDE0.055MG/SPRAYSPRAY, METERED / NASAL2023-01-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A214615-001TRIAMCINOLONE ACETONIDE0.055MG/SPRAYSPRAY, METERED / NASAL2023-01-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214615-001TRIAMCINOLONE ACETONIDE0.055MG/SPRAYSPRAY, METERED / NASAL2023-01-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A214615-001TRIAMCINOLONE ACETONIDE0.055MG/SPRAYSPRAY, METERED / NASAL2023-01-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214615-001TRIAMCINOLONE ACETONIDE0.055MG/SPRAYSPRAY, METERED / NASAL2023-01-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214615-001TRIAMCINOLONE ACETONIDE0.055MG/SPRAYSPRAY, METERED / NASAL2023-01-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214615-001TRIAMCINOLONE ACETONIDE0.055MG/SPRAYSPRAY, METERED / NASAL2023-01-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214615-001TRIAMCINOLONE ACETONIDE0.055MG/SPRAYSPRAY, METERED / NASAL2023-01-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214615-001TRIAMCINOLONE ACETONIDE0.055MG/SPRAYSPRAY, METERED / NASAL2023-01-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214615-001TRIAMCINOLONE ACETONIDE0.055MG/SPRAYSPRAY, METERED / NASAL2023-01-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214615-001TRIAMCINOLONE ACETONIDE0.055MG/SPRAYSPRAY, METERED / NASAL2023-01-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214615-001TRIAMCINOLONE ACETONIDE0.055MG/SPRAYSPRAY, METERED / NASAL2023-01-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214615-001TRIAMCINOLONE ACETONIDE0.055MG/SPRAYSPRAY, METERED / NASAL2023-01-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214615-001TRIAMCINOLONE ACETONIDE0.055MG/SPRAYSPRAY, METERED / NASAL2023-01-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214615-001TRIAMCINOLONE ACETONIDE0.055MG/SPRAYSPRAY, METERED / NASAL2023-01-198072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A214615-001TRIAMCINOLONE ACETONIDE0.055MG/SPRAYSPRAY, METERED / NASAL2023-01-196a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A214615-001TRIAMCINOLONE ACETONIDE0.055MG/SPRAYSPRAY, METERED / NASAL2023-01-191c564ffb4f44…
2023-12-20 04:57 UTC2023-12A214615-001TRIAMCINOLONE ACETONIDE0.055MG/SPRAYSPRAY, METERED / NASAL2023-01-19ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A214615-001TRIAMCINOLONE ACETONIDE0.055MG/SPRAYSPRAY, METERED / NASAL2023-01-19a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A214615-001TRIAMCINOLONE ACETONIDE0.055MG/SPRAYSPRAY, METERED / NASAL2023-01-199b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A214615-001TRIAMCINOLONE ACETONIDE0.055MG/SPRAYSPRAY, METERED / NASAL2023-01-19a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A214615-001TRIAMCINOLONE ACETONIDE0.055MG/SPRAYSPRAY, METERED / NASAL2023-01-193f0d92c62455…
2023-05-13 08:27 UTC2023-05A214615-001TRIAMCINOLONE ACETONIDE0.055MG/SPRAYSPRAY, METERED / NASAL2023-01-19053a50430f4f…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214615-001TRIAMCINOLONE ACETONIDE0.055MG/SPRAYSPRAY, METERED / NASAL2023-01-19a50c72e98297…

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 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDECARDINAL HEALTH 110, LLC. DBA LEADER 70000444ca70e-fa06-4808-bd9d-d53ee725b7522026-05-21WarningsExact identifier
application applno (ANDA): 214615
application number: ANDA214615
Nasal AllergyTRIAMCINOLONE ACETONIDERugby Laboratories0ae25bc9-5d90-4dd8-9620-8684c4fd9d372026-05-21WarningsExact identifier
application applno (ANDA): 214615
application number: ANDA214615
Triamcinolone acetonideTRIAMCINOLONE ACETONIDEApotex Corp.a0cde3d7-4934-ed19-78c0-01f21275cba02025-09-22WarningsExact identifier
application applno (ANDA): 214615
application number: ANDA214615
Triamcinolone acetonideTRIAMCINOLONE ACETONIDEAllegiant Health1fd76a49-61ee-4d4d-8abc-e666b2d3c5b02025-07-29WarningsExact identifier
application applno (ANDA): 214615
application number: ANDA214615
Triamcinolone acetonideTRIAMCINOLONE ACETONIDECARDINAL HEALTH 110, LLC. DBA LEADERc8000539-125f-f0dd-2f69-580eea235a772025-06-03WarningsExact identifier
application applno (ANDA): 214615
application number: ANDA214615