Application 040039

Type: ANDA
Sponsor: TARO PHARM INDS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	CREAM;TOPICAL	0.1%	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
A040039-001	TRIAMCINOLONE ACETONIDE	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT		1997-11-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040039-001	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 · 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	A040039-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	1997-11-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040039-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	1997-11-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040039-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	1997-11-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040039-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	1997-11-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040039-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	1997-11-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040039-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	1997-11-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040039-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	1997-11-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040039-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	1997-11-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040039-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	1997-11-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040039-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	1997-11-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040039-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	1997-11-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040039-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	1997-11-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040039-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	1997-11-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040039-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	1997-11-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040039-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	1997-11-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040039-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	1997-11-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040039-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	1997-11-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040039-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	1997-11-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040039-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	1997-11-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040039-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	1997-11-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040039-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	1997-11-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040039-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	1997-11-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040039-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	1997-11-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040039-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	1997-11-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040039-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	1997-11-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040039-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	1997-11-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040039-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	1997-11-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040039-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	1997-11-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040039-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	1997-11-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040039-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	1997-11-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040039-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	1997-11-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040039-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	1997-11-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040039-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	1997-11-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040039-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	1997-11-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040039-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	1997-11-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040039-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	1997-11-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040039-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	1997-11-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040039-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	1997-11-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040039-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	1997-11-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040039-001	TRIAMCINOLONE ACETONIDE	0.1%	CREAM / TOPICAL	AT	1997-11-26	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A040039-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040039-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040039-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040039-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040039-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040039-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040039-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040039-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040039-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040039-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040039-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040039-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040039-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040039-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040039-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040039-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040039-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040039-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040039-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040039-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040039-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040039-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040039-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040039-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040039-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040039-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040039-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040039-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040039-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040039-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040039-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040039-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040039-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040039-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040039-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040039-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040039-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040039-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040039-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040039-001	AT	1	`e64feba35796…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Sun Pharmaceutical Industries, Inc.	e7e16fc2-0222-44f5-925b-928d249f55cf	2025-10-15	Adverse reactions	Exact identifier application applno (ANDA): 040039 application number: ANDA040039 ndc (product): 51672-1282
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Preferred Pharmaceuticals Inc.	99f8a0e6-8ee8-4430-b1d5-1022da1d72ab	2025-10-01	Adverse reactions	Exact identifier application applno (ANDA): 040039 application number: ANDA040039
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	NuCare Pharmaceuticals,Inc.	dff0403f-1c0c-3333-e053-2a95a90a4c09	2024-12-24	Adverse reactions	Exact identifier application applno (ANDA): 040039 application number: ANDA040039 ndc (product): 68071-2736
Triamcinolone Acetonide	TRIAMCINOLONE ACETONIDE	Proficient Rx LP	de5bad69-a014-4e25-b1b9-214373ca57a5	2024-02-01	Adverse reactions	Exact identifier application applno (ANDA): 040039 application number: ANDA040039

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
24338-430	Pediaderm TA	Triamcinolone Acetonide	Arbor Pharmaceuticals, Inc.	ANDA	Current
35356-753	Triamcinolone Acetonide	Triamcinolone Acetonide	Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC	ANDA	Current
51672-1282	Triamcinolone Acetonide	Triamcinolone Acetonide	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-1282	Triamcinolone Acetonide	Triamcinolone Acetonide	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-1282	Triamcinolone Acetonide	Triamcinolone Acetonide	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
68071-2736	Triamcinolone Acetonide	Triamcinolone Acetonide	NuCare Pharmaceuticals,Inc.	ANDA	Current
70518-1926	Triamcinolone Acetonide	Triamcinolone Acetonide	REMEDYREPACK INC.	ANDA	Current