Application 085691

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	OINTMENT;TOPICAL	0.025%	No	No
002	TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	OINTMENT;TOPICAL	0.5%	No	No
003	TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	OINTMENT;TOPICAL	0.1%	No	No

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
A085691-001	TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT / TOPICAL	AT	Approved before 1982
A085691-002	TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	Approved before 1982
A085691-003	TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	AT	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
A085691-001	AT
A085691-002	AT
A085691-003	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 2 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
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A085691-002	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A085691-003	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	AT	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A085691-001	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT / TOPICAL	AT	Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A085691-002	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A085691-003	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	AT	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A085691-001	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT / TOPICAL	AT	Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A085691-002	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A085691-003	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	AT	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A085691-001	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT / TOPICAL	AT	Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A085691-002	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A085691-003	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	AT	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A085691-001	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT / TOPICAL	AT	Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A085691-002	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A085691-003	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	AT	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A085691-001	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT / TOPICAL	AT	Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A085691-002	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A085691-003	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	AT	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A085691-001	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT / TOPICAL	AT	Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A085691-002	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A085691-003	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	AT	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A085691-001	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT / TOPICAL	AT	Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A085691-002	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A085691-003	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	AT	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A085691-001	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT / TOPICAL	AT	Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A085691-002	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A085691-003	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	AT	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A085691-001	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT / TOPICAL	AT	Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A085691-002	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A085691-003	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	AT	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A085691-001	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT / TOPICAL	AT	Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A085691-002	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A085691-003	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	AT	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A085691-001	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT / TOPICAL	AT	Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A085691-002	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A085691-003	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	AT	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A085691-001	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT / TOPICAL	AT	Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A085691-002	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A085691-003	TRIAMCINOLONE ACETONIDE	0.1%	OINTMENT / TOPICAL	AT	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A085691-001	TRIAMCINOLONE ACETONIDE	0.025%	OINTMENT / TOPICAL	AT	Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A085691-002	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	Approved before 1982	`c0c555d07b60…`

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	A085691-001	AT	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A085691-002	AT	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A085691-003	AT	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A085691-001	AT	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A085691-002	AT	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A085691-003	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A085691-001	AT	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A085691-002	AT	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A085691-003	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A085691-001	AT	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A085691-002	AT	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A085691-003	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085691-001	AT	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085691-002	AT	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085691-003	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A085691-001	AT	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A085691-002	AT	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A085691-003	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085691-001	AT	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085691-002	AT	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085691-003	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085691-001	AT	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085691-002	AT	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085691-003	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085691-001	AT	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085691-002	AT	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085691-003	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A085691-001	AT	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A085691-002	AT	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A085691-003	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A085691-001	AT	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A085691-002	AT	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A085691-003	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A085691-001	AT	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A085691-002	AT	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A085691-003	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A085691-001	AT	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A085691-002	AT	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A085691-003	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A085691-001	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Asclemed USA, Inc.	b20c22b2-9a74-4b71-9015-40838fd2d193	2026-03-10	Adverse reactions	Exact identifier application applno (ANDA): 085691 application number: ANDA085691
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC	a5cc640f-c72d-49fa-b970-906c9ffd8629	2026-01-28	Adverse reactions	Exact identifier application applno (ANDA): 085691 application number: ANDA085691 ndc (product): 0168-0005 ndc (product): 0168-0006
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Bryant Ranch Prepack	ee274346-938b-4678-9146-486ca65bcba5	2024-01-15	Adverse reactions	Exact identifier application applno (ANDA): 085691 application number: ANDA085691 ndc (product): 63629-8841

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 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0168-0005	Triamcinolone Acetonide	triamcinolone acetonide	E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.	ANDA	Current
0168-0006	Triamcinolone Acetonide	triamcinolone acetonide	E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.	ANDA	Current
21695-503	triamcinolone acetonide	triamcinolone acetonide	Rebel Distributors Corp	ANDA	Current
21695-504	triamcinolone acetonide	triamcinolone acetonide	Rebel Distributors Corp	ANDA	Current
42254-176	triamcinolone acetonide	triamcinolone acetonide	Rebel Distributors Corp	ANDA	Current
49999-216	Triamcinolone Acetonide	triamcinolone acetonide	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
49999-216	Triamcinolone Acetonide	triamcinolone acetonide	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
49999-216	Triamcinolone Acetonide	triamcinolone acetonide	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
50090-0163	Triamcinolone Acetonide	triamcinolone acetonide	A-S Medication Solutions	ANDA	Current
50090-0240	Triamcinolone Acetonide	triamcinolone acetonide	A-S Medication Solutions	ANDA	Current
63629-8841	Triamcinolone Acetonide	triamcinolone acetonide	Bryant Ranch Prepack	ANDA	Current
63629-8841	Triamcinolone Acetonide	triamcinolone acetonide	Bryant Ranch Prepack	ANDA	Current