Application 080745

Type: ANDA
Sponsor: ASTELLAS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	ARISTOCORT	TRIAMCINOLONE ACETONIDE	OINTMENT;TOPICAL	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No
003	ARISTOCORT A	TRIAMCINOLONE ACETONIDE	OINTMENT;TOPICAL	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A080745-002	ARISTOCORT	TRIAMCINOLONE ACETONIDE	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL		RLD, Approved before 1982
A080745-003	ARISTOCORT A	TRIAMCINOLONE ACETONIDE	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL		RLD, Approved before 1982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 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	A080745-002	ARISTOCORT	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD, Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A080745-003	ARISTOCORT A	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD, Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A080745-002	ARISTOCORT	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A080745-003	ARISTOCORT A	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A080745-002	ARISTOCORT	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A080745-003	ARISTOCORT A	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080745-002	ARISTOCORT	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080745-003	ARISTOCORT A	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A080745-002	ARISTOCORT	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A080745-003	ARISTOCORT A	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080745-002	ARISTOCORT	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080745-003	ARISTOCORT A	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080745-002	ARISTOCORT	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080745-003	ARISTOCORT A	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080745-002	ARISTOCORT	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080745-003	ARISTOCORT A	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080745-002	ARISTOCORT	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080745-003	ARISTOCORT A	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080745-002	ARISTOCORT	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080745-003	ARISTOCORT A	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080745-002	ARISTOCORT	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080745-003	ARISTOCORT A	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A080745-002	ARISTOCORT	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A080745-003	ARISTOCORT A	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080745-002	ARISTOCORT	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080745-003	ARISTOCORT A	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A080745-002	ARISTOCORT	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A080745-003	ARISTOCORT A	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A080745-002	ARISTOCORT	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A080745-003	ARISTOCORT A	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A080745-002	ARISTOCORT	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD, Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A080745-003	ARISTOCORT A	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A080745-002	ARISTOCORT	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A080745-003	ARISTOCORT A	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A080745-002	ARISTOCORT	0.5%	OINTMENT / TOPICAL	RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A080745-003	ARISTOCORT A	0.5%	OINTMENT / TOPICAL	RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A080745-002	ARISTOCORT	0.5%	OINTMENT / TOPICAL	RLD, Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A080745-003	ARISTOCORT A	0.5%	OINTMENT / TOPICAL	RLD, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A080745-002	ARISTOCORT	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	OINTMENT / TOPICAL	Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A080745-003	ARISTOCORT A	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	OINTMENT / TOPICAL	Approved before 1982	`74a2ff9319b5…`

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 6 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	Preferred Pharmaceuticals Inc.	5040eba2-2d00-496a-8773-66ba5440610f	2025-06-27	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	NuCare Pharmaceuticals, Inc.	3597dccf-079c-5cd9-e063-6294a90aca71	2025-05-20	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Asclemed USA, Inc.	915b93be-425f-41b5-a9b0-5831b7e040a5	2025-05-16	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	A-S Medication Solutions	da474ee7-ac67-4e62-991d-ca979f13dea2	2025-05-15	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Up and Up Nasal Allergy	TRIAMCINOLONE ACETONIDE	Target Corporation	492852c5-39eb-477f-9045-aaf50cf3306e	2025-04-29	Warnings	Name fallback generic name: TRIAMCINOLONE ACETONIDE
NASACORT	TRIAMCINOLONE ACETONIDE	A-S Medication Solutions	37f290c9-576d-463f-b7d4-a146f53855b0	2025-04-23	Warnings	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Eugia US LLC	d9abdda5-80e3-407c-b636-9cc5fc438098	2025-04-15	Warnings, Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Rising Pharma Holdings, Inc.	15ab1090-47d1-4925-8362-d7dda6fe74a9	2025-04-11	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone acetonide	TRIAMCINOLONE ACETONIDE	NorthStar RxLLC	3379f247-4a29-4373-9843-0b7f044c2276	2025-04-03	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Preferred Pharmaceuticals Inc.	da5652f8-585c-4697-bc65-2a613cb0ef0f	2025-03-20	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	NuCare Pharmaceuticals, Inc.	30b89788-4d90-617e-e063-6394a90a29dd	2025-03-19	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Saptalis Pharmaceuticals, LLC.	8cbde037-da83-4390-8465-7e383eee9287	2025-03-03	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	NuCare Pharmaceuticals,Inc.	696cd64f-28dd-3dae-e053-2a91aa0a0c76	2025-02-13	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Hikma Pharmaceuticals USA Inc.	c940a2d5-09a5-413b-b5a1-d8da8907bafd	2025-01-29	Warnings, Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Preferred Pharmaceuticals Inc	df6f5944-ba12-4731-9749-9095b3570dd3	2025-01-16	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Good Neighbor Pharmacy 24 Hour Nasal Allergy	TRIAMCINOLONE ACETONIDE	Amerisource Bergen	cccf50ee-60e1-44a1-a353-5949e8f85c0a	2025-01-04	Warnings	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone acetonide	TRIAMCINOLONE ACETONIDE	Advanced Rx Pharmacy of Tennessee, LLC	f4c077f2-2609-2235-e053-2995a90a1b57	2024-12-31	Warnings, Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Padagis Israel Pharmaceuticals Ltd	5d2fe6c2-3856-47f6-843f-077b2e1080a0	2024-12-31	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	MICRO LABS LIMITED	22608943-79b1-4795-9231-ac4e166309d2	2024-12-27	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	NuCare Pharmaceuticals,Inc.	dff0403f-1c0c-3333-e053-2a95a90a4c09	2024-12-24	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE

Reported adverse events (FAERS/openFDA)#

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