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TRIAMCINOLONE ACETONIDE	OINTMENT;TOPICAL	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No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A	TRIAMCINOLONE ACETONIDE	OINTMENT;TOPICAL	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	No	No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A080745-002	ARISTOCORT	TRIAMCINOLONE ACETONIDE	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL		RLD, Approved before 1982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ARISTOCORT A	TRIAMCINOLONE ACETONIDE	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL		RLD, Approved before 1982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 2 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
2022-03-09 01:35 UTC	2022-03	A080745-002	ARISTOCORT	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A080745-003	ARISTOCORT A	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	OINTMENT / TOPICAL	RLD, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A080745-002	ARISTOCORT	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	OINTMENT / TOPICAL	RLD, Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A080745-003	ARISTOCORT A	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	OINTMENT / TOPICAL	RLD, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	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	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	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	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	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	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	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	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	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	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	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	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	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	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	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	`c0c555d07b60…`
2019-12-14 00:12 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	`3f01610625f2…`
2019-12-14 00:12 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	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	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	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	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	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	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	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	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	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	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	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	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	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	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	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	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	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	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	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	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	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	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	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	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	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	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	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	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	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	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	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	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	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	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	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	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	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	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	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	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	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	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	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	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	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	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	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	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	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	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	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	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	`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 1 of 11 · 206 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	A-S Medication Solutions	93041e9c-3320-4617-b1c1-68c95bf6b770	2026-09-23	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone acetonide	TRIAMCINOLONE ACETONIDE	Redpharm Drug	5a79639b-eb66-e726-e063-6394a90aeb01	2026-09-02	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone acetonide	TRIAMCINOLONE ACETONIDE	REMEDYREPACK INC.	d10b5451-5685-489e-b123-55c99d33c5b2	2026-08-31	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	Bryant Ranch Prepack	f549f9ea-abc0-4fc2-b6ec-c21182eb26e6	2026-08-27	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	Bryant Ranch Prepack	b5297665-7979-4021-bfce-9119083a2a36	2026-08-26	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	Bryant Ranch Prepack	04ef72a9-6aa1-4d64-b598-f281215229a4	2026-08-25	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	Bryant Ranch Prepack	20fa27ca-807a-4513-8af5-a835541d60d5	2026-08-24	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Sagent Pharmaceuticals	7dbee70b-bd11-4430-b626-97fbb8f01b49	2026-08-14	Warnings, Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
CHILDRENS TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	Aurohealth LLC	9e50af36-59f1-4f08-a0d7-7566f0a11034	2026-08-13	Warnings	Name fallback generic name: TRIAMCINOLONE ACETONIDE
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	Aurohealth LLC	a74eff58-bce4-4785-b583-3e474f825070	2026-08-13	Warnings	Name fallback generic name: TRIAMCINOLONE ACETONIDE
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	Bryant Ranch Prepack	3a85b137-7ef0-4b1d-8590-69c139355a13	2026-08-10	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	Bryant Ranch Prepack	b2ba93bc-3775-466b-8daf-4ffa3edc9c00	2026-08-10	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	Bryant Ranch Prepack	f152b99c-5363-40f9-9fad-c3e36b7c3df1	2026-08-10	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triadermex	TRIAMCINOLONE ACETONIDE	Florrax Pharmaceutical	3bda5cd1-df3c-4b4c-9868-cbc41f66f5a6	2026-08-06	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Nasal Allergy	TRIAMCINOLONE ACETONIDE	HyVee Inc	5ad719a7-3872-4d0c-93e6-603e4653ec42	2026-08-05	Warnings	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	REMEDYREPACK INC.	3051aa96-b12a-4a1d-947d-9b769bca8dc8	2026-07-31	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
KENALOG-10	TRIAMCINOLONE ACETONIDE	A-S Medication Solutions	653ec195-0966-478d-be47-6b1ff158e111	2026-07-30	Warnings, Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Preferred Pharmaceuticals Inc.	3d495acf-8085-4aaa-8fc5-594b88c25c21	2026-07-13	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Sportpharm LLC	20c1234b-6749-422d-9420-9d5a98f5f30a	2026-07-13	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	Ascend Laboratories, LLC	ccca8660-124e-4220-8d87-4b9aeecbda7d	2026-07-13	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE

Reported adverse events (FAERS/openFDA)#

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