Application 040672

Type: ANDA
Sponsor: SAPTALIS PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	LOTION;TOPICAL	0.1%	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A040672-002	TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.1%	LOTION / TOPICAL	AT		2006-12-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040672-002	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 1 of 2 · 41 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
2026-02-19 14:30 UTC	2026-02	A040672-002	TRIAMCINOLONE ACETONIDE	0.1%	LOTION / TOPICAL	AT	2006-12-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040672-002	TRIAMCINOLONE ACETONIDE	0.1%	LOTION / TOPICAL	AT	2006-12-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040672-002	TRIAMCINOLONE ACETONIDE	0.1%	LOTION / TOPICAL	AT	2006-12-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040672-002	TRIAMCINOLONE ACETONIDE	0.1%	LOTION / TOPICAL	AT	2006-12-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040672-002	TRIAMCINOLONE ACETONIDE	0.1%	LOTION / TOPICAL	AT	2006-12-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040672-002	TRIAMCINOLONE ACETONIDE	0.1%	LOTION / TOPICAL	AT	2006-12-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040672-002	TRIAMCINOLONE ACETONIDE	0.1%	LOTION / TOPICAL	AT	2006-12-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040672-002	TRIAMCINOLONE ACETONIDE	0.1%	LOTION / TOPICAL	AT	2006-12-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040672-002	TRIAMCINOLONE ACETONIDE	0.1%	LOTION / TOPICAL	AT	2006-12-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040672-002	TRIAMCINOLONE ACETONIDE	0.1%	LOTION / TOPICAL	AT	2006-12-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040672-002	TRIAMCINOLONE ACETONIDE	0.1%	LOTION / TOPICAL	AT	2006-12-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040672-002	TRIAMCINOLONE ACETONIDE	0.1%	LOTION / TOPICAL	AT	2006-12-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040672-002	TRIAMCINOLONE ACETONIDE	0.1%	LOTION / TOPICAL	AT	2006-12-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040672-002	TRIAMCINOLONE ACETONIDE	0.1%	LOTION / TOPICAL	AT	2006-12-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040672-002	TRIAMCINOLONE ACETONIDE	0.1%	LOTION / TOPICAL	AT	2006-12-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040672-002	TRIAMCINOLONE ACETONIDE	0.1%	LOTION / TOPICAL	AT	2006-12-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040672-002	TRIAMCINOLONE ACETONIDE	0.1%	LOTION / TOPICAL	AT	2006-12-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040672-002	TRIAMCINOLONE ACETONIDE	0.1%	LOTION / TOPICAL	AT	2006-12-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040672-002	TRIAMCINOLONE ACETONIDE	0.1%	LOTION / TOPICAL	AT	2006-12-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040672-002	TRIAMCINOLONE ACETONIDE	0.1%	LOTION / TOPICAL	AT	2006-12-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040672-002	TRIAMCINOLONE ACETONIDE	0.1%	LOTION / TOPICAL	AT	2006-12-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040672-002	TRIAMCINOLONE ACETONIDE	0.1%	LOTION / TOPICAL	AT	2006-12-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040672-002	TRIAMCINOLONE ACETONIDE	0.1%	LOTION / TOPICAL	AT	2006-12-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040672-002	TRIAMCINOLONE ACETONIDE	0.1%	LOTION / TOPICAL	AT	2006-12-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040672-002	TRIAMCINOLONE ACETONIDE	0.1%	LOTION / TOPICAL	AT	2006-12-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040672-002	TRIAMCINOLONE ACETONIDE	0.1%	LOTION / TOPICAL	AT	2006-12-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040672-002	TRIAMCINOLONE ACETONIDE	0.1%	LOTION / TOPICAL	AT	2006-12-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040672-002	TRIAMCINOLONE ACETONIDE	0.1%	LOTION / TOPICAL	AT	2006-12-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040672-002	TRIAMCINOLONE ACETONIDE	0.1%	LOTION / TOPICAL	AT	2006-12-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040672-002	TRIAMCINOLONE ACETONIDE	0.1%	LOTION / TOPICAL	AT	2006-12-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040672-002	TRIAMCINOLONE ACETONIDE	0.1%	LOTION / TOPICAL	AT	2006-12-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040672-002	TRIAMCINOLONE ACETONIDE	0.1%	LOTION / TOPICAL	AT	2006-12-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040672-002	TRIAMCINOLONE ACETONIDE	0.1%	LOTION / TOPICAL	AT	2006-12-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040672-002	TRIAMCINOLONE ACETONIDE	0.1%	LOTION / TOPICAL	AT	2006-12-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040672-002	TRIAMCINOLONE ACETONIDE	0.1%	LOTION / TOPICAL	AT	2006-12-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040672-002	TRIAMCINOLONE ACETONIDE	0.1%	LOTION / TOPICAL	AT	2006-12-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040672-002	TRIAMCINOLONE ACETONIDE	0.1%	LOTION / TOPICAL	AT	2006-12-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040672-002	TRIAMCINOLONE ACETONIDE	0.1%	LOTION / TOPICAL	AT	2006-12-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040672-002	TRIAMCINOLONE ACETONIDE	0.1%	LOTION / TOPICAL	AT	2006-12-13	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040672-002	TRIAMCINOLONE ACETONIDE	0.1%	LOTION / TOPICAL	AT	2006-12-13	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040672-002	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040672-002	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040672-002	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040672-002	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040672-002	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040672-002	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040672-002	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040672-002	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040672-002	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040672-002	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040672-002	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040672-002	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040672-002	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040672-002	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040672-002	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040672-002	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040672-002	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040672-002	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040672-002	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040672-002	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040672-002	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040672-002	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040672-002	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040672-002	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040672-002	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040672-002	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040672-002	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040672-002	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040672-002	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040672-002	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040672-002	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040672-002	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040672-002	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040672-002	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040672-002	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040672-002	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040672-002	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040672-002	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040672-002	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040672-002	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	MICRO LABS LIMITED	22608943-79b1-4795-9231-ac4e166309d2	2024-12-27	Adverse reactions	Exact identifier application applno (ANDA): 040672 application number: ANDA040672 ndc (product): 42571-385
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Saptalis Pharmaceuticals, LLC.	a77a31dd-048e-4a4d-b006-6913978d7438	2024-11-13	Adverse reactions	Exact identifier application applno (ANDA): 040672 application number: ANDA040672

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0603-7864	Triamcinolone Acetonide	Triamcinolone Acetonide	Par Pharmaceutical	ANDA	Current
42571-385	Triamcinolone Acetonide	triamcinolone acetonide	MICRO LABS LIMITED	ANDA	Current
42571-385	Triamcinolone Acetonide	triamcinolone acetonide	MICRO LABS LIMITED	ANDA	Current