Application 208590

Type: ANDA
Sponsor: TELIGENT PHARMA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	OINTMENT;TOPICAL	0.5%	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A208590-001	TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL			2017-03-03

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 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A208590-001	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL		2017-03-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208590-001	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL		2017-03-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208590-001	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL		2017-03-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208590-001	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL		2017-03-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208590-001	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL		2017-03-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208590-001	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL		2017-03-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208590-001	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL		2017-03-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208590-001	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL		2017-03-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208590-001	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL		2017-03-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208590-001	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL		2017-03-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208590-001	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL		2017-03-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208590-001	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL		2017-03-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208590-001	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL		2017-03-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208590-001	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL		2017-03-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208590-001	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL		2017-03-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208590-001	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	2017-03-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208590-001	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	2017-03-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208590-001	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	2017-03-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208590-001	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	2017-03-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208590-001	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	2017-03-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208590-001	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	2017-03-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208590-001	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	2017-03-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208590-001	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	2017-03-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208590-001	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	2017-03-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208590-001	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	2017-03-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208590-001	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	2017-03-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208590-001	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	2017-03-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208590-001	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	2017-03-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208590-001	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL		2017-03-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208590-001	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL		2017-03-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208590-001	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL		2017-03-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208590-001	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL		2017-03-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208590-001	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL		2017-03-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208590-001	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	2017-03-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208590-001	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	2017-03-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208590-001	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	2017-03-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208590-001	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	2017-03-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208590-001	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	2017-03-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208590-001	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	2017-03-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208590-001	TRIAMCINOLONE ACETONIDE	0.5%	OINTMENT / TOPICAL	AT	2017-03-03	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208590-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208590-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208590-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208590-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208590-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208590-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208590-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208590-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208590-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208590-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208590-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208590-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208590-001	AT	1	`ea99ee380514…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208590-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208590-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208590-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208590-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208590-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208590-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208590-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208590-001	AT	1	`cb3db0bc1861…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Proficient Rx LP	b05fddfb-7d63-42d8-b41a-003492d3922c	2022-09-01	Adverse reactions	Exact identifier application applno (ANDA): 208590 application number: ANDA208590 ndc (product): 71205-033
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Proficient Rx LP	e5e3a38d-717d-4412-80d3-7130100add0a	2020-09-01	Adverse reactions	Exact identifier application applno (ANDA): 208590 application number: ANDA208590 ndc (product): 71205-038

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
52565-048	Triamcinolone Acetonide	triamcinolone acetonide	Teligent Pharma, Inc.	ANDA	Current
52565-048	Triamcinolone Acetonide	triamcinolone acetonide	Teligent Pharma, Inc.	ANDA	Current
52565-048	Triamcinolone Acetonide	triamcinolone acetonide	Teligent Pharma, Inc.	ANDA	Current
53002-0151	Triamcinolone Acetonide	triamcinolone acetonide	RPK Pharmaceuticals, Inc.	ANDA	Current
70518-1097	Triamcinolone Acetonide	triamcinolone acetonide	REMEDYREPACK INC.	ANDA	Current
71205-033	Triamcinolone Acetonide	triamcinolone acetonide	Proficient Rx LP	ANDA	Current
71205-033	Triamcinolone Acetonide	triamcinolone acetonide	Proficient Rx LP	ANDA	Current
71205-033	Triamcinolone Acetonide	triamcinolone acetonide	Proficient Rx LP	ANDA	Current
71205-033	Triamcinolone Acetonide	triamcinolone acetonide	Proficient Rx LP	ANDA	Current
71205-038	Triamcinolone Acetonide	triamcinolone acetonide	Proficient Rx LP	ANDA	Current
71205-038	Triamcinolone Acetonide	triamcinolone acetonide	Proficient Rx LP	ANDA	Current
71205-038	Triamcinolone Acetonide	triamcinolone acetonide	Proficient Rx LP	ANDA	Current