Application 083017

Type
ANDA
Sponsor
ASTELLAS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
003ARISTOCORTTRIAMCINOLONE ACETONIDECREAM;TOPICAL0.025%NoNo
004ARISTOCORT ATRIAMCINOLONE ACETONIDECREAM;TOPICAL0.025%NoNo

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A083017-003ARISTOCORTTRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICALApproved before 1982
A083017-004ARISTOCORT ATRIAMCINOLONE ACETONIDE0.025%CREAM / TOPICALApproved before 1982

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 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A083017-003ARISTOCORT0.025%CREAM / TOPICALApproved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07A083017-004ARISTOCORT A0.025%CREAM / TOPICALApproved before 1982caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A083017-003ARISTOCORT0.025%CREAM / TOPICALApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A083017-004ARISTOCORT A0.025%CREAM / TOPICALApproved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A083017-003ARISTOCORT0.025%CREAM / TOPICALApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A083017-004ARISTOCORT A0.025%CREAM / TOPICALApproved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08A083017-003ARISTOCORT0.025%CREAM / TOPICALApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A083017-004ARISTOCORT A0.025%CREAM / TOPICALApproved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A083017-003ARISTOCORT0.025%CREAM / TOPICALApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A083017-004ARISTOCORT A0.025%CREAM / TOPICALApproved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A083017-003ARISTOCORT0.025%CREAM / TOPICALApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A083017-004ARISTOCORT A0.025%CREAM / TOPICALApproved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A083017-003ARISTOCORT0.025%CREAM / TOPICALApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A083017-004ARISTOCORT A0.025%CREAM / TOPICALApproved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A083017-003ARISTOCORT0.025%CREAM / TOPICALApproved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A083017-004ARISTOCORT A0.025%CREAM / TOPICALApproved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A083017-003ARISTOCORT0.025%CREAM / TOPICALApproved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A083017-004ARISTOCORT A0.025%CREAM / TOPICALApproved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A083017-003ARISTOCORT0.025%CREAM / TOPICALApproved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A083017-004ARISTOCORT A0.025%CREAM / TOPICALApproved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A083017-003ARISTOCORT0.025%CREAM / TOPICALApproved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10A083017-004ARISTOCORT A0.025%CREAM / TOPICALApproved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A083017-003ARISTOCORT0.025%CREAM / TOPICALApproved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A083017-004ARISTOCORT A0.025%CREAM / TOPICALApproved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A083017-003ARISTOCORT0.025%CREAM / TOPICALApproved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A083017-004ARISTOCORT A0.025%CREAM / TOPICALApproved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A083017-003ARISTOCORT0.025%CREAM / TOPICALApproved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A083017-004ARISTOCORT A0.025%CREAM / TOPICALApproved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05A083017-003ARISTOCORT0.025%CREAM / TOPICALApproved before 19828072bd15b7f6…
2024-05-31 18:47 UTC2024-05A083017-004ARISTOCORT A0.025%CREAM / TOPICALApproved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A083017-003ARISTOCORT0.025%CREAM / TOPICALApproved before 19825c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A083017-004ARISTOCORT A0.025%CREAM / TOPICALApproved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A083017-003ARISTOCORT0.025%CREAM / TOPICALApproved before 19825d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A083017-004ARISTOCORT A0.025%CREAM / TOPICALApproved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A083017-003ARISTOCORT0.025%CREAM / TOPICALApproved before 19824b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A083017-004ARISTOCORT A0.025%CREAM / TOPICALApproved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A083017-003ARISTOCORT0.025%CREAM / TOPICALApproved before 198274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A083017-004ARISTOCORT A0.025%CREAM / TOPICALApproved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A083017-003ARISTOCORT0.025%CREAM / TOPICALApproved before 1982bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A083017-004ARISTOCORT A0.025%CREAM / TOPICALApproved before 1982bb7c543d1eb4…

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 11 · 211 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEBryant Ranch Prepack04ef72a9-6aa1-4d64-b598-f281215229a42026-08-25Adverse reactionsName fallback
generic name: TRIAMCINOLONE ACETONIDE
TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEBryant Ranch Prepack20fa27ca-807a-4513-8af5-a835541d60d52026-08-24Adverse reactionsName fallback
generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDESagent Pharmaceuticals7dbee70b-bd11-4430-b626-97fbb8f01b492026-08-14Warnings, Adverse reactionsName fallback
generic name: TRIAMCINOLONE ACETONIDE
CHILDRENS TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEAurohealth LLC9e50af36-59f1-4f08-a0d7-7566f0a110342026-08-13WarningsName fallback
generic name: TRIAMCINOLONE ACETONIDE
TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEAurohealth LLCa74eff58-bce4-4785-b583-3e474f8250702026-08-13WarningsName fallback
generic name: TRIAMCINOLONE ACETONIDE
TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEBryant Ranch Prepack3a85b137-7ef0-4b1d-8590-69c139355a132026-08-10Adverse reactionsName fallback
generic name: TRIAMCINOLONE ACETONIDE
TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEBryant Ranch Prepackb2ba93bc-3775-466b-8daf-4ffa3edc9c002026-08-10Adverse reactionsName fallback
generic name: TRIAMCINOLONE ACETONIDE
TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEBryant Ranch Prepackf152b99c-5363-40f9-9fad-c3e36b7c3df12026-08-10Adverse reactionsName fallback
generic name: TRIAMCINOLONE ACETONIDE
TriadermexTRIAMCINOLONE ACETONIDEFlorrax Pharmaceutical3bda5cd1-df3c-4b4c-9868-cbc41f66f5a62026-08-06Adverse reactionsName fallback
generic name: TRIAMCINOLONE ACETONIDE
Nasal AllergyTRIAMCINOLONE ACETONIDEHyVee Inc5ad719a7-3872-4d0c-93e6-603e4653ec422026-08-05WarningsName fallback
generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEREMEDYREPACK INC.3051aa96-b12a-4a1d-947d-9b769bca8dc82026-07-31Adverse reactionsName fallback
generic name: TRIAMCINOLONE ACETONIDE
KENALOG-10TRIAMCINOLONE ACETONIDEA-S Medication Solutions653ec195-0966-478d-be47-6b1ff158e1112026-07-30Warnings, Adverse reactionsName fallback
generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEPreferred Pharmaceuticals Inc.3d495acf-8085-4aaa-8fc5-594b88c25c212026-07-13Adverse reactionsName fallback
generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDESportpharm LLC20c1234b-6749-422d-9420-9d5a98f5f30a2026-07-13Adverse reactionsName fallback
generic name: TRIAMCINOLONE ACETONIDE
TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEAscend Laboratories, LLCccca8660-124e-4220-8d87-4b9aeecbda7d2026-07-13Adverse reactionsName fallback
generic name: TRIAMCINOLONE ACETONIDE
TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEEncube Ethicals, Inc.db87426f-124c-4ea9-bb15-fc3a0da10a4e2026-07-07Adverse reactionsName fallback
generic name: TRIAMCINOLONE ACETONIDE
TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDEEncube Ethicals, Inc.6a31a0c3-2b6e-40e3-b5ea-5c665afd35672026-07-06Adverse reactionsName fallback
generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEA-S Medication Solutions089a8449-7810-48ec-b327-494f058c33482026-06-22Adverse reactionsName fallback
generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEAmneal Pharmaceuticals LLC6b6eed06-ff96-4ceb-bb0c-a67a149987a42026-06-18Warnings, Adverse reactionsName fallback
generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone AcetonideTRIAMCINOLONE ACETONIDEAmneal Pharmaceuticals LLCbf0b4d32-c8b7-48c9-a29b-3e7c2afc6cbf2026-06-17Warnings, Adverse reactionsName fallback
generic name: TRIAMCINOLONE ACETONIDE