Application 088819

Type: ANDA
Sponsor: ASTELLAS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ARISTOCORT A	TRIAMCINOLONE ACETONIDE	CREAM;TOPICAL	0.1%	No	No

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A088819-001	ARISTOCORT A	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL			1984-10-16

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A088819-001	ARISTOCORT A	0.1%	CREAM / TOPICAL	1984-10-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A088819-001	ARISTOCORT A	0.1%	CREAM / TOPICAL	1984-10-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A088819-001	ARISTOCORT A	0.1%	CREAM / TOPICAL	1984-10-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088819-001	ARISTOCORT A	0.1%	CREAM / TOPICAL	1984-10-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088819-001	ARISTOCORT A	0.1%	CREAM / TOPICAL	1984-10-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088819-001	ARISTOCORT A	0.1%	CREAM / TOPICAL	1984-10-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088819-001	ARISTOCORT A	0.1%	CREAM / TOPICAL	1984-10-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088819-001	ARISTOCORT A	0.1%	CREAM / TOPICAL	1984-10-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088819-001	ARISTOCORT A	0.1%	CREAM / TOPICAL	1984-10-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088819-001	ARISTOCORT A	0.1%	CREAM / TOPICAL	1984-10-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088819-001	ARISTOCORT A	0.1%	CREAM / TOPICAL	1984-10-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088819-001	ARISTOCORT A	0.1%	CREAM / TOPICAL	1984-10-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088819-001	ARISTOCORT A	0.1%	CREAM / TOPICAL	1984-10-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088819-001	ARISTOCORT A	0.1%	CREAM / TOPICAL	1984-10-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088819-001	ARISTOCORT A	0.1%	CREAM / TOPICAL	1984-10-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088819-001	ARISTOCORT A	0.1%	CREAM / TOPICAL	1984-10-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088819-001	ARISTOCORT A	0.1%	CREAM / TOPICAL	1984-10-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088819-001	ARISTOCORT A	0.1%	CREAM / TOPICAL	1984-10-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088819-001	ARISTOCORT A	0.1%	CREAM / TOPICAL	1984-10-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088819-001	ARISTOCORT A	0.1%	CREAM / TOPICAL	1984-10-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088819-001	ARISTOCORT A	0.1%	CREAM / TOPICAL	1984-10-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088819-001	ARISTOCORT A	0.1%	CREAM / TOPICAL	1984-10-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088819-001	ARISTOCORT A	0.1%	CREAM / TOPICAL	1984-10-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088819-001	ARISTOCORT A	0.1%	CREAM / TOPICAL	1984-10-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088819-001	ARISTOCORT A	0.1%	CREAM / TOPICAL	1984-10-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088819-001	ARISTOCORT A	0.1%	CREAM / TOPICAL	1984-10-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088819-001	ARISTOCORT A	0.1%	CREAM / TOPICAL	1984-10-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088819-001	ARISTOCORT A	0.1%	CREAM / TOPICAL	1984-10-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088819-001	ARISTOCORT A	0.1%	CREAM / TOPICAL	1984-10-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088819-001	ARISTOCORT A	0.1%	CREAM / TOPICAL	1984-10-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088819-001	ARISTOCORT A	0.1%	CREAM / TOPICAL	1984-10-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088819-001	ARISTOCORT A	0.1%	CREAM / TOPICAL	1984-10-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088819-001	ARISTOCORT A	0.1%	CREAM / TOPICAL	1984-10-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088819-001	ARISTOCORT A	0.1%	CREAM / TOPICAL	1984-10-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088819-001	ARISTOCORT A	0.1%	CREAM / TOPICAL	1984-10-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088819-001	ARISTOCORT A	0.1%	CREAM / TOPICAL	1984-10-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088819-001	ARISTOCORT A	0.1%	CREAM / TOPICAL	1984-10-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088819-001	ARISTOCORT A	0.1%	CREAM / TOPICAL	1984-10-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088819-001	ARISTOCORT A	0.1%	CREAM / TOPICAL	1984-10-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088819-001	ARISTOCORT A	0.1%	CREAM / TOPICAL	1984-10-16	`f41ea6bd6efb…`

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 11 of 11 · 208 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Asclemed USA, Inc.	1edfc7c0-616c-475e-bcde-49270765f710	2021-11-30	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Strides Pharma Science Limited	cfd1f3bd-0284-443b-8bdf-3e44f1f9bc82	2021-06-23	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	Cintex Services, LLC	be0270a4-5596-499e-aea2-8e63b3edc852	2020-11-20	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Proficient Rx LP	e5e3a38d-717d-4412-80d3-7130100add0a	2020-09-01	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
KENALOG-40	TRIAMCINOLONE ACETONIDE	Asclemed USA, Inc.	0bc9c75f-963c-40b0-995b-dfcbd50371a5	2020-05-06	Warnings, Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Proficient Rx LP	41c1fe93-0509-4cf6-ac35-049028b731de	2019-12-01	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Glenmark Pharmaceuticals Inc., USA	8c380328-127b-4ca6-bf56-ef461e704471	2017-08-22	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Glenmark Pharmaceuticals Inc., USA	a9b3764d-fd3d-4fcc-8d22-5aa848da1b06	2016-07-11	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE

Reported adverse events (FAERS/openFDA)#

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