Application 085692

Type: ANDA
Sponsor: FOUGERA PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	CREAM;TOPICAL	0.025%	No	Yes
002	TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	CREAM;TOPICAL	0.5%	No	Yes
003	TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	CREAM;TOPICAL	0.1%	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS
A085692-001	TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982
A085692-002	TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.5%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982
A085692-003	TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A085692-001	AT
A085692-002	AT
A085692-003	AT

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 4 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A085692-001	TRIAMCINOLONE ACETONIDE	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A085692-002	TRIAMCINOLONE ACETONIDE	0.5%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A085692-003	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A085692-001	TRIAMCINOLONE ACETONIDE	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A085692-002	TRIAMCINOLONE ACETONIDE	0.5%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A085692-003	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A085692-001	TRIAMCINOLONE ACETONIDE	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A085692-002	TRIAMCINOLONE ACETONIDE	0.5%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A085692-003	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A085692-001	TRIAMCINOLONE ACETONIDE	0.025%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A085692-002	TRIAMCINOLONE ACETONIDE	0.5%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A085692-003	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	RLD, RS, Approved before 1982	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A085692-001	AT	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A085692-002	AT	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A085692-003	AT	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A085692-001	AT	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A085692-002	AT	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A085692-003	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A085692-001	AT	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A085692-002	AT	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A085692-003	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A085692-001	AT	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A085692-002	AT	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A085692-003	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085692-001	AT	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085692-002	AT	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085692-003	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A085692-001	AT	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A085692-002	AT	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A085692-003	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085692-001	AT	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085692-002	AT	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085692-003	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085692-001	AT	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085692-002	AT	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085692-003	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085692-001	AT	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085692-002	AT	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085692-003	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A085692-001	AT	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A085692-002	AT	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A085692-003	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A085692-001	AT	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A085692-002	AT	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A085692-003	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A085692-001	AT	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A085692-002	AT	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A085692-003	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A085692-001	AT	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A085692-002	AT	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A085692-003	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A085692-001	AT	1	`79d66fd596c7…`

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 1 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	DIRECTRX	835bbcd1-3869-646c-e053-2a91aa0a796a	2026-03-17	Adverse reactions	Exact identifier application applno (ANDA): 085692 application number: ANDA085692 ndc (product): 61919-650
triamcinolone acetonide	TRIAMCINOLONE ACETONIDE	E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC	92a1ded0-8e1a-4994-9c8a-89e84fc85c94	2026-01-28	Adverse reactions	Exact identifier application applno (ANDA): 085692 application number: ANDA085692 ndc (product): 0168-0002 ndc (product): 0168-0003 ndc (product): 0168-0004
triamcinolone acetonide	TRIAMCINOLONE ACETONIDE	Preferred Pharmaceuticals Inc.	5701a07f-bd22-4bc7-95ff-0c5444ea5971	2025-10-01	Adverse reactions	Exact identifier application applno (ANDA): 085692 application number: ANDA085692
triamcinolone acetonide	TRIAMCINOLONE ACETONIDE	Preferred Pharmaceuticals Inc.	5040eba2-2d00-496a-8773-66ba5440610f	2025-06-27	Adverse reactions	Exact identifier application applno (ANDA): 085692 application number: ANDA085692
triamcinolone acetonide	TRIAMCINOLONE ACETONIDE	A-S Medication Solutions	2d6b9c2f-f1a0-413e-b333-64da52368202	2023-12-09	Adverse reactions	Exact identifier application applno (ANDA): 085692 application number: ANDA085692 ndc (product): 50090-0293
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Proficient Rx LP	41c1fe93-0509-4cf6-ac35-049028b731de	2019-12-01	Adverse reactions	Exact identifier application applno (ANDA): 085692 application number: ANDA085692 ndc (product): 63187-214 ndc (product): 63187-053

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0168-0002	triamcinolone acetonide	triamcinolone acetonide	E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.	ANDA	Current
0168-0003	triamcinolone acetonide	triamcinolone acetonide	E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.	ANDA	Current
0168-0004	triamcinolone acetonide	triamcinolone acetonide	E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.	ANDA	Current
21695-189	Triamcinolone Acetonide	Triamcinolone Acetonide	Rebel Distributors Corp	ANDA	Current
21695-501	Triamcinolone Acetonide	Triamcinolone Acetonide	Rebel Distributors Corp	ANDA	Current
21695-502	Triamcinolone Acetonide	Triamcinolone Acetonide	Rebel Distributors Corp	ANDA	Current
35356-658	triamcinolone acetonide	triamcinolone acetonide	Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC	ANDA	Current
50090-0293	triamcinolone acetonide	triamcinolone acetonide	A-S Medication Solutions	ANDA	Current
50090-0293	triamcinolone acetonide	triamcinolone acetonide	A-S Medication Solutions	ANDA	Current
50090-0324	triamcinolone acetonide	triamcinolone acetonide	A-S Medication Solutions	ANDA	Current
50436-0842	triamcinolone acetonide	triamcinolone acetonide	Unit Dose Services	ANDA	Current
61919-650	TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	DIRECTRX	ANDA	Current
61919-650	TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	DIRECTRX	ANDA	Current
63187-053	Triamcinolone Acetonide	Triamcinolone Acetonide	Proficient Rx LP	ANDA	Current
63187-053	Triamcinolone Acetonide	Triamcinolone Acetonide	Proficient Rx LP	ANDA	Current
63187-214	Triamcinolone Acetonide	Triamcinolone Acetonide	Proficient Rx LP	ANDA	Current
63187-214	Triamcinolone Acetonide	Triamcinolone Acetonide	Proficient Rx LP	ANDA	Current
68788-6795	triamcinolone acetonide	triamcinolone acetonide	Preferred Pharmaceuticals	ANDA	Current
70518-0136	triamcinolone acetonide	triamcinolone acetonide	REMEDYREPACK INC.	ANDA	Current
70518-0136	triamcinolone acetonide	triamcinolone acetonide	REMEDYREPACK INC.	ANDA	Current