Application 083017

Type: ANDA
Sponsor: ASTELLAS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
003	ARISTOCORT	TRIAMCINOLONE ACETONIDE	CREAM;TOPICAL	0.025%	No	No
004	ARISTOCORT A	TRIAMCINOLONE ACETONIDE	CREAM;TOPICAL	0.025%	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
A083017-003	ARISTOCORT	TRIAMCINOLONE ACETONIDE	0.025%	CREAM / TOPICAL		Approved before 1982
A083017-004	ARISTOCORT A	TRIAMCINOLONE ACETONIDE	0.025%	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	A083017-003	ARISTOCORT	0.025%	CREAM / TOPICAL	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A083017-004	ARISTOCORT A	0.025%	CREAM / TOPICAL	Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A083017-003	ARISTOCORT	0.025%	CREAM / TOPICAL	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A083017-004	ARISTOCORT A	0.025%	CREAM / TOPICAL	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A083017-003	ARISTOCORT	0.025%	CREAM / TOPICAL	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A083017-004	ARISTOCORT A	0.025%	CREAM / TOPICAL	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083017-003	ARISTOCORT	0.025%	CREAM / TOPICAL	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083017-004	ARISTOCORT A	0.025%	CREAM / TOPICAL	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A083017-003	ARISTOCORT	0.025%	CREAM / TOPICAL	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A083017-004	ARISTOCORT A	0.025%	CREAM / TOPICAL	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A083017-003	ARISTOCORT	0.025%	CREAM / TOPICAL	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A083017-004	ARISTOCORT A	0.025%	CREAM / TOPICAL	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A083017-003	ARISTOCORT	0.025%	CREAM / TOPICAL	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A083017-004	ARISTOCORT A	0.025%	CREAM / TOPICAL	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A083017-003	ARISTOCORT	0.025%	CREAM / TOPICAL	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A083017-004	ARISTOCORT A	0.025%	CREAM / TOPICAL	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A083017-003	ARISTOCORT	0.025%	CREAM / TOPICAL	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A083017-004	ARISTOCORT A	0.025%	CREAM / TOPICAL	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A083017-003	ARISTOCORT	0.025%	CREAM / TOPICAL	Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A083017-004	ARISTOCORT A	0.025%	CREAM / TOPICAL	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A083017-003	ARISTOCORT	0.025%	CREAM / TOPICAL	Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A083017-004	ARISTOCORT A	0.025%	CREAM / TOPICAL	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A083017-003	ARISTOCORT	0.025%	CREAM / TOPICAL	Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A083017-004	ARISTOCORT A	0.025%	CREAM / TOPICAL	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A083017-003	ARISTOCORT	0.025%	CREAM / TOPICAL	Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A083017-004	ARISTOCORT A	0.025%	CREAM / TOPICAL	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A083017-003	ARISTOCORT	0.025%	CREAM / TOPICAL	Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A083017-004	ARISTOCORT A	0.025%	CREAM / TOPICAL	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A083017-003	ARISTOCORT	0.025%	CREAM / TOPICAL	Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A083017-004	ARISTOCORT A	0.025%	CREAM / TOPICAL	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A083017-003	ARISTOCORT	0.025%	CREAM / TOPICAL	Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A083017-004	ARISTOCORT A	0.025%	CREAM / TOPICAL	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A083017-003	ARISTOCORT	0.025%	CREAM / TOPICAL	Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A083017-004	ARISTOCORT A	0.025%	CREAM / TOPICAL	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A083017-003	ARISTOCORT	0.025%	CREAM / TOPICAL	Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A083017-004	ARISTOCORT A	0.025%	CREAM / TOPICAL	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A083017-003	ARISTOCORT	0.025%	CREAM / TOPICAL	Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A083017-004	ARISTOCORT A	0.025%	CREAM / TOPICAL	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A083017-003	ARISTOCORT	0.025%	CREAM / TOPICAL	Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A083017-004	ARISTOCORT A	0.025%	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 7 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	TruPharma, LLC	888f2b6f-1d11-4774-9eab-714af40edb7d	2024-12-23	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	NuCare Pharmaceuticals,Inc.	a4d74513-0548-4f11-e053-2995a90a1830	2024-12-13	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	Mylan Institutional LLC	4015ad7d-46bf-454e-ac86-91fa5dd6a07b	2024-12-05	Warnings, Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Cosette Pharmaceuticals, Inc.	5397395a-2d13-9311-7cb2-c316339d4acc	2024-12-04	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
nasal allergy	TRIAMCINOLONE ACETONIDE	Kroger Company	b5f3bb98-4eb5-4c25-ae90-e2aa9ff5667d	2024-11-27	Warnings	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Bryant Ranch Prepack	c29de67c-c4c7-412b-ae5f-b5562a95a8f9	2024-11-20	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	Bryant Ranch Prepack	c2b12aa8-1875-489b-8d16-fb588ad3cf54	2024-11-20	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Saptalis Pharmaceuticals, LLC.	a77a31dd-048e-4a4d-b006-6913978d7438	2024-11-13	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone acetonide	TRIAMCINOLONE ACETONIDE	Bryant Ranch Prepack	a7c85d92-734e-4175-b1a7-eaff97abc45c	2024-11-12	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	Proficient Rx LP	c6e46d6f-c64d-4242-a56f-8aff96e68993	2024-10-01	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
KENALOG-10	TRIAMCINOLONE ACETONIDE	E.R. Squibb & Sons, L.L.C.	ec04ecbb-2896-3feb-85fd-a64aba93b289	2024-08-26	Warnings, Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
KENALOG-40	TRIAMCINOLONE ACETONIDE	E.R. Squibb & Sons, L.L.C.	cf970688-cd77-b95c-4bd9-c541590e9722	2024-08-20	Warnings, Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	NuCare Pharmaceuticals, Inc.	200bb913-a6ac-5a6b-e063-6294a90a161a	2024-08-19	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	Bryant Ranch Prepack	3d709ea2-060f-4b16-b1fd-191fb4484312	2024-08-15	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone acetonide	TRIAMCINOLONE ACETONIDE	Bryant Ranch Prepack	0bf47993-615c-4d89-8e02-145f59315362	2024-08-14	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide Nasal	TRIAMCINOLONE ACETONIDE	Bryant Ranch Prepack	ddcaf82b-3aaa-4dba-91be-8f71fce7a6e0	2024-08-14	Warnings	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Teva Parenteral Medicines, Inc.	1680315d-dcdc-407a-b8e8-8710587197d2	2024-07-31	Warnings, Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide Nasal	TRIAMCINOLONE ACETONIDE	Padagis Israel Pharmaceuticals Ltd	8468115a-4f0c-4ae8-bcd6-38f8b81cf871	2024-07-25	Warnings	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone acetonide	TRIAMCINOLONE ACETONIDE	NuCare Pharmaceuticals,Inc.	b43d4e4a-6206-4449-e053-2a95a90a721a	2024-07-17	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Bryant Ranch Prepack	69786597-99f9-4bdc-91bc-c50e5fd682c8	2024-06-26	Adverse reactions	Name fallback generic name: TRIAMCINOLONE ACETONIDE

Reported adverse events (FAERS/openFDA)#

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