Application 083016

Type: ANDA
Sponsor: ASTELLAS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
004	ARISTOCORT	TRIAMCINOLONE ACETONIDE	CREAM;TOPICAL	0.1%	No	No
005	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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A083016-004	ARISTOCORT	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL		Approved before 1982
A083016-005	ARISTOCORT A	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL		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	A083016-004	ARISTOCORT	0.1%	CREAM / TOPICAL	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A083016-005	ARISTOCORT A	0.1%	CREAM / TOPICAL	Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A083016-004	ARISTOCORT	0.1%	CREAM / TOPICAL	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A083016-005	ARISTOCORT A	0.1%	CREAM / TOPICAL	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A083016-004	ARISTOCORT	0.1%	CREAM / TOPICAL	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A083016-005	ARISTOCORT A	0.1%	CREAM / TOPICAL	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083016-004	ARISTOCORT	0.1%	CREAM / TOPICAL	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083016-005	ARISTOCORT A	0.1%	CREAM / TOPICAL	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A083016-004	ARISTOCORT	0.1%	CREAM / TOPICAL	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A083016-005	ARISTOCORT A	0.1%	CREAM / TOPICAL	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A083016-004	ARISTOCORT	0.1%	CREAM / TOPICAL	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A083016-005	ARISTOCORT A	0.1%	CREAM / TOPICAL	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A083016-004	ARISTOCORT	0.1%	CREAM / TOPICAL	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A083016-005	ARISTOCORT A	0.1%	CREAM / TOPICAL	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A083016-004	ARISTOCORT	0.1%	CREAM / TOPICAL	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A083016-005	ARISTOCORT A	0.1%	CREAM / TOPICAL	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A083016-004	ARISTOCORT	0.1%	CREAM / TOPICAL	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A083016-005	ARISTOCORT A	0.1%	CREAM / TOPICAL	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A083016-004	ARISTOCORT	0.1%	CREAM / TOPICAL	Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A083016-005	ARISTOCORT A	0.1%	CREAM / TOPICAL	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A083016-004	ARISTOCORT	0.1%	CREAM / TOPICAL	Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A083016-005	ARISTOCORT A	0.1%	CREAM / TOPICAL	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A083016-004	ARISTOCORT	0.1%	CREAM / TOPICAL	Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A083016-005	ARISTOCORT A	0.1%	CREAM / TOPICAL	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A083016-004	ARISTOCORT	0.1%	CREAM / TOPICAL	Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A083016-005	ARISTOCORT A	0.1%	CREAM / TOPICAL	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A083016-004	ARISTOCORT	0.1%	CREAM / TOPICAL	Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A083016-005	ARISTOCORT A	0.1%	CREAM / TOPICAL	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A083016-004	ARISTOCORT	0.1%	CREAM / TOPICAL	Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A083016-005	ARISTOCORT A	0.1%	CREAM / TOPICAL	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A083016-004	ARISTOCORT	0.1%	CREAM / TOPICAL	Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A083016-005	ARISTOCORT A	0.1%	CREAM / TOPICAL	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A083016-004	ARISTOCORT	0.1%	CREAM / TOPICAL	Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A083016-005	ARISTOCORT A	0.1%	CREAM / TOPICAL	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A083016-004	ARISTOCORT	0.1%	CREAM / TOPICAL	Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A083016-005	ARISTOCORT A	0.1%	CREAM / TOPICAL	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A083016-004	ARISTOCORT	0.1%	CREAM / TOPICAL	Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A083016-005	ARISTOCORT A	0.1%	CREAM / TOPICAL	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A083016-004	ARISTOCORT	0.1%	CREAM / TOPICAL	Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A083016-005	ARISTOCORT A	0.1%	CREAM / 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 9 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	Bryant Ranch Prepack	72038652-b15a-4a84-bccc-d50731ac5f03	2023-11-01	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	A-S Medication Solutions	b6beaa63-5bd8-4936-8611-ba2389388027	2023-10-31	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone acetonide	TRIAMCINOLONE ACETONIDE	Bryant Ranch Prepack	ad88de0e-6e01-4056-b259-841fb67d2db0	2023-10-30	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Topcare Nasal Allergy	TRIAMCINOLONE ACETONIDE	Topco Associates LLC	ed8eaf1d-babc-47e1-930b-676ccfbf0de9	2023-10-10	Warnings	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Padagis Israel Pharmaceuticals Ltd	838ba2fa-5133-4975-bd99-791891a144c5	2023-10-01	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone acetonide	TRIAMCINOLONE ACETONIDE	Proficient Rx LP	6bb0edc7-643b-4b20-aa48-ee3b22bce575	2023-10-01	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone acetonide	TRIAMCINOLONE ACETONIDE	Macleods Pharmaceuticals Limited	43481ee3-0419-44c9-93ab-4fab9baa9273	2023-08-21	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone acetonide	TRIAMCINOLONE ACETONIDE	Bryant Ranch Prepack	70116d71-97a9-4a9b-bf1d-e79c8ef596e2	2023-08-04	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Equaline nasal allergy	TRIAMCINOLONE ACETONIDE	United Natural Foods, Inc. dba UNFI	6efd653e-82ee-43a5-9544-699f2cfabe9d	2023-08-01	Warnings	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	A-S Medication Solutions	0d40e68d-feb5-4061-8b43-515b2f553371	2023-07-31	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
triamcinolone acetonide	TRIAMCINOLONE ACETONIDE	Bryant Ranch Prepack	e4e2aeed-e9c4-4f35-8cd2-7439785d9ffb	2023-07-17	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	A-S Medication Solutions	9c418bf0-7de3-4389-81e8-b1e2887af7c5	2023-07-11	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Macleods Pharmaceuticals Limited	5873c78d-a9d4-49fc-95b8-5d4a368e9109	2023-07-01	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone acetonide	TRIAMCINOLONE ACETONIDE	Macleods Pharmaceuticals Limited	4dc6fa38-0225-4b99-8cef-4fee72a30f90	2023-07-01	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
foster and thrive 24 hour nasal allergy	TRIAMCINOLONE ACETONIDE	Strategic Sourcing Services LLC	eb5e5496-d270-4c26-aac1-0506f458d45b	2023-06-30	Warnings	Name fallback generic name: TRIAMCINOLONE ACETONIDE
KENALOG-40	TRIAMCINOLONE ACETONIDE	A-S Medication Solutions	cb0480b8-44ee-4506-b484-dc776c3092dc	2023-06-15	Warnings, Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone acetonide	TRIAMCINOLONE ACETONIDE	Proficient Rx LP	7dc12943-7702-4c84-b507-2ea207d02460	2023-06-01	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Padagis Israel Pharmaceuticals Ltd	8c8307ed-d0c9-4f74-84a8-1471677a4f2a	2023-05-01	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	A-S Medication Solutions	c21c3a96-d491-4a60-a09e-d0eccd34b20f	2023-02-28	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	QUAGEN PHARMACEUTICALS LLC	22c80caa-730e-41c4-b772-18a369e76885	2023-02-15	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE

Reported adverse events (FAERS/openFDA)#

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