Application 040671

Type: ANDA
Sponsor: MLV

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	No
002	TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	CREAM;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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A040671-001	TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.025%	CREAM / TOPICAL	AT		2006-06-09
A040671-002	TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT		2006-06-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A040671-001	AT
A040671-002	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 3 · 82 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	A040671-001	TRIAMCINOLONE ACETONIDE	0.025%	CREAM / TOPICAL	AT	2006-06-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040671-002	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2006-06-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040671-001	TRIAMCINOLONE ACETONIDE	0.025%	CREAM / TOPICAL	AT	2006-06-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040671-002	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2006-06-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040671-001	TRIAMCINOLONE ACETONIDE	0.025%	CREAM / TOPICAL	AT	2006-06-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040671-002	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2006-06-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040671-001	TRIAMCINOLONE ACETONIDE	0.025%	CREAM / TOPICAL	AT	2006-06-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040671-002	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2006-06-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040671-001	TRIAMCINOLONE ACETONIDE	0.025%	CREAM / TOPICAL	AT	2006-06-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040671-002	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2006-06-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040671-001	TRIAMCINOLONE ACETONIDE	0.025%	CREAM / TOPICAL	AT	2006-06-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040671-002	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2006-06-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040671-001	TRIAMCINOLONE ACETONIDE	0.025%	CREAM / TOPICAL	AT	2006-06-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040671-002	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2006-06-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040671-001	TRIAMCINOLONE ACETONIDE	0.025%	CREAM / TOPICAL	AT	2006-06-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040671-002	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2006-06-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040671-001	TRIAMCINOLONE ACETONIDE	0.025%	CREAM / TOPICAL	AT	2006-06-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040671-002	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2006-06-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040671-001	TRIAMCINOLONE ACETONIDE	0.025%	CREAM / TOPICAL	AT	2006-06-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040671-002	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2006-06-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040671-001	TRIAMCINOLONE ACETONIDE	0.025%	CREAM / TOPICAL	AT	2006-06-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040671-002	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2006-06-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040671-001	TRIAMCINOLONE ACETONIDE	0.025%	CREAM / TOPICAL	AT	2006-06-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040671-002	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2006-06-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040671-001	TRIAMCINOLONE ACETONIDE	0.025%	CREAM / TOPICAL	AT	2006-06-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040671-002	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2006-06-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040671-001	TRIAMCINOLONE ACETONIDE	0.025%	CREAM / TOPICAL	AT	2006-06-09	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040671-002	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2006-06-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040671-001	TRIAMCINOLONE ACETONIDE	0.025%	CREAM / TOPICAL	AT	2006-06-09	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040671-002	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2006-06-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040671-001	TRIAMCINOLONE ACETONIDE	0.025%	CREAM / TOPICAL	AT	2006-06-09	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040671-002	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2006-06-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040671-001	TRIAMCINOLONE ACETONIDE	0.025%	CREAM / TOPICAL	AT	2006-06-09	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040671-002	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2006-06-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040671-001	TRIAMCINOLONE ACETONIDE	0.025%	CREAM / TOPICAL	AT	2006-06-09	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040671-002	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2006-06-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040671-001	TRIAMCINOLONE ACETONIDE	0.025%	CREAM / TOPICAL	AT	2006-06-09	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040671-002	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2006-06-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040671-001	TRIAMCINOLONE ACETONIDE	0.025%	CREAM / TOPICAL	AT	2006-06-09	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040671-002	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	2006-06-09	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A040671-001	AT	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040671-002	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040671-001	AT	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040671-002	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040671-001	AT	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040671-002	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040671-001	AT	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040671-002	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040671-001	AT	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040671-002	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040671-001	AT	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040671-002	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040671-001	AT	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040671-002	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040671-001	AT	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040671-002	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040671-001	AT	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040671-002	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040671-001	AT	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040671-002	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040671-001	AT	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040671-002	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040671-001	AT	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040671-002	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040671-001	AT	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040671-002	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040671-001	AT	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040671-002	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040671-001	AT	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040671-002	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040671-001	AT	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040671-002	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040671-001	AT	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040671-002	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040671-001	AT	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040671-002	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040671-001	AT	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040671-002	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040671-001	AT	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040671-002	AT	1	`782e0a99824c…`

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	Saptalis Pharmaceuticals, LLC.	8cbde037-da83-4390-8465-7e383eee9287	2025-03-03	Adverse reactions	Exact identifier application applno (ANDA): 040671 application number: ANDA040671
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	TruPharma, LLC	888f2b6f-1d11-4774-9eab-714af40edb7d	2024-12-23	Adverse reactions	Exact identifier application applno (ANDA): 040671 application number: ANDA040671 ndc (product): 52817-811

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0603-7862	Triamcinolone Acetonide	triamcinolone acetonide	Par Pharmaceutical	ANDA	Current
50090-2055	Triamcinolone Acetonide	triamcinolone acetonide	A-S Medication Solutions	ANDA	Current
52817-811	Triamcinolone Acetonide	triamcinolone acetonide	TruPharma, LLC	ANDA	Current
53217-014	Triamcinolone Acetonide	triamcinolone acetonide	Aidarex Pharmaceuticals LLC	ANDA	Current
68788-9883	Triamcinolone Acetonide	triamcinolone acetonide	Preferred Pharmaceuticals	ANDA	Current
69329-251	NEWSDS pak	Triamcinolone Acetonide Cream, Dimethicone Cream	Patchwerx Labs, Inc.	ANDA	Current
69329-251	NEWSDS pak	Triamcinolone Acetonide Cream, Dimethicone Cream	Patchwerx Labs, Inc.	ANDA	Current
75840-093	SanaDermRx SKin Repair	Triamcinolone Acetonide Cream Kit	GenPak Solutions, LLC	ANDA	Current