Application 087932

Type
ANDA
Sponsor
AMBIX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDECREAM;TOPICAL0.025%NoNo

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

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
A087932-001TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICAL1983-05-09

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A087932-001TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICAL1983-05-0984e616aacf4f…
2026-08-18 06:07:402026-07A087932-001TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICAL1983-05-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A087932-001TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICAL1983-05-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A087932-001TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICAL1983-05-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A087932-001TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICAL1983-05-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A087932-001TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICAL1983-05-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A087932-001TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICAL1983-05-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A087932-001TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICAL1983-05-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A087932-001TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICAL1983-05-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A087932-001TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICAL1983-05-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A087932-001TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICAL1983-05-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A087932-001TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICAL1983-05-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A087932-001TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICAL1983-05-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A087932-001TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICAL1983-05-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A087932-001TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICAL1983-05-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A087932-001TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICAL1983-05-098072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A087932-001TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICAL1983-05-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A087932-001TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICAL1983-05-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A087932-001TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICAL1983-05-094b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A087932-001TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICAL1983-05-0974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A087932-001TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICAL1983-05-09bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A087932-001TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICAL1983-05-09782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A087932-001TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICAL1983-05-0987673890dc5c…
2021-03-12 10:30 UTC2021-03A087932-001TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICAL1983-05-095aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A087932-001TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICAL1983-05-098869cabd3fbd…
2020-11-12 02:37 UTC2020-11A087932-001TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICAL1983-05-09c0c555d07b60…
2019-12-14 00:12 UTC2019-12A087932-001TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICAL1983-05-093f01610625f2…
2019-09-15 20:21 UTC2019-09A087932-001TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICAL1983-05-09b00525d2431f…
2019-07-19 19:46 UTC2019-07A087932-001TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICAL1983-05-09ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A087932-001TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICAL1983-05-096a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A087932-001TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICAL1983-05-091c564ffb4f44…
2023-12-20 04:57 UTC2023-12A087932-001TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICAL1983-05-09ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A087932-001TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICAL1983-05-09a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A087932-001TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICAL1983-05-099b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A087932-001TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICAL1983-05-09a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A087932-001TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICAL1983-05-093f0d92c62455…
2023-05-13 08:27 UTC2023-05A087932-001TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICAL1983-05-09053a50430f4f…
2023-01-26 05:58 UTC2023-01A087932-001TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICAL1983-05-093bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A087932-001TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICAL1983-05-093a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A087932-001TRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICAL1983-05-09f41ea6bd6efb…

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 7 of 11 · 211 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEMICRO LABS LIMITED22608943-79b1-4795-9231-ac4e166309d22024-12-27Adverse reactionsName fallback
brand name: Triamcinolone Acetonide
generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDENuCare Pharmaceuticals,Inc.dff0403f-1c0c-3333-e053-2a95a90a4c092024-12-24Adverse reactionsName fallback
brand name: Triamcinolone Acetonide
generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDETruPharma, LLC888f2b6f-1d11-4774-9eab-714af40edb7d2024-12-23Adverse reactionsName fallback
brand name: Triamcinolone Acetonide
generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDENuCare Pharmaceuticals,Inc.a4d74513-0548-4f11-e053-2995a90a18302024-12-13Adverse reactionsName fallback
brand name: Triamcinolone Acetonide
generic name: TRIAMCINOLONE ACETONIDE
TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEMylan Institutional LLC4015ad7d-46bf-454e-ac86-91fa5dd6a07b2024-12-05Warnings, Adverse reactionsName fallback
brand name: TRIAMCINOLONE ACETONIDE
generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDECosette Pharmaceuticals, Inc.5397395a-2d13-9311-7cb2-c316339d4acc2024-12-04Adverse reactionsName fallback
brand name: Triamcinolone Acetonide
generic name: TRIAMCINOLONE ACETONIDE
nasal allergyTRIAMCINOLONE ACETONIDEKroger Companyb5f3bb98-4eb5-4c25-ae90-e2aa9ff5667d2024-11-27WarningsName fallback
generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEBryant Ranch Prepackc29de67c-c4c7-412b-ae5f-b5562a95a8f92024-11-20Adverse reactionsName fallback
brand name: Triamcinolone Acetonide
generic name: TRIAMCINOLONE ACETONIDE
TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEBryant Ranch Prepackc2b12aa8-1875-489b-8d16-fb588ad3cf542024-11-20Adverse reactionsName fallback
brand name: TRIAMCINOLONE ACETONIDE
generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDESaptalis Pharmaceuticals, LLC.a77a31dd-048e-4a4d-b006-6913978d74382024-11-13Adverse reactionsName fallback
brand name: Triamcinolone Acetonide
generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone acetonideTRIAMCINOLONE ACETONIDEBryant Ranch Prepacka7c85d92-734e-4175-b1a7-eaff97abc45c2024-11-12Adverse reactionsName fallback
brand name: Triamcinolone acetonide
generic name: TRIAMCINOLONE ACETONIDE
TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEProficient Rx LPc6e46d6f-c64d-4242-a56f-8aff96e689932024-10-01Adverse reactionsName fallback
brand name: TRIAMCINOLONE ACETONIDE
generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDE OINTMENT USP, 0.05%Northstar Rx LLCfb7c85fa-56f1-4cb1-821d-0f6c9adc83f62024-09-03Adverse reactionsName fallback
brand name: Triamcinolone Acetonide
KENALOG-10TRIAMCINOLONE ACETONIDEE.R. Squibb & Sons, L.L.C.ec04ecbb-2896-3feb-85fd-a64aba93b2892024-08-26Warnings, Adverse reactionsName fallback
generic name: TRIAMCINOLONE ACETONIDE
KENALOG-40TRIAMCINOLONE ACETONIDEE.R. Squibb & Sons, L.L.C.cf970688-cd77-b95c-4bd9-c541590e97222024-08-20Warnings, Adverse reactionsName fallback
generic name: TRIAMCINOLONE ACETONIDE
TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDENuCare Pharmaceuticals, Inc.200bb913-a6ac-5a6b-e063-6294a90a161a2024-08-19Adverse reactionsName fallback
brand name: TRIAMCINOLONE ACETONIDE
generic name: TRIAMCINOLONE ACETONIDE
TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEBryant Ranch Prepack3d709ea2-060f-4b16-b1fd-191fb44843122024-08-15Adverse reactionsName fallback
brand name: TRIAMCINOLONE ACETONIDE
generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone acetonideTRIAMCINOLONE ACETONIDEBryant Ranch Prepack0bf47993-615c-4d89-8e02-145f593153622024-08-14Adverse reactionsName fallback
brand name: Triamcinolone acetonide
generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide NasalTRIAMCINOLONE ACETONIDEBryant Ranch Prepackddcaf82b-3aaa-4dba-91be-8f71fce7a6e02024-08-14WarningsName fallback
generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDETeva Parenteral Medicines, Inc.1680315d-dcdc-407a-b8e8-8710587197d22024-07-31Warnings, Adverse reactionsName fallback
brand name: Triamcinolone Acetonide
generic name: TRIAMCINOLONE ACETONIDE

Reported adverse events (FAERS/openFDA)#

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