Application 076043

Type: ANDA
Sponsor: TARO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TERCONAZOLE	TERCONAZOLE	CREAM;VAGINAL	0.4%	No	Yes

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
A076043-001	TERCONAZOLE	TERCONAZOLE	0.4%	CREAM / VAGINAL	AB	RS	2005-01-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076043-001	AB

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A076043-001	TERCONAZOLE	0.4%	CREAM / VAGINAL	AB	RS	2005-01-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076043-001	TERCONAZOLE	0.4%	CREAM / VAGINAL	AB	RS	2005-01-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076043-001	TERCONAZOLE	0.4%	CREAM / VAGINAL	AB	RS	2005-01-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076043-001	TERCONAZOLE	0.4%	CREAM / VAGINAL	AB	RS	2005-01-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076043-001	TERCONAZOLE	0.4%	CREAM / VAGINAL	AB	RS	2005-01-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076043-001	TERCONAZOLE	0.4%	CREAM / VAGINAL	AB	RS	2005-01-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076043-001	TERCONAZOLE	0.4%	CREAM / VAGINAL	AB	RS	2005-01-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076043-001	TERCONAZOLE	0.4%	CREAM / VAGINAL	AB	RS	2005-01-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076043-001	TERCONAZOLE	0.4%	CREAM / VAGINAL	AB	RS	2005-01-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076043-001	TERCONAZOLE	0.4%	CREAM / VAGINAL	AB	RS	2005-01-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076043-001	TERCONAZOLE	0.4%	CREAM / VAGINAL	AB	RS	2005-01-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076043-001	TERCONAZOLE	0.4%	CREAM / VAGINAL	AB	RS	2005-01-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076043-001	TERCONAZOLE	0.4%	CREAM / VAGINAL	AB	RS	2005-01-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076043-001	TERCONAZOLE	0.4%	CREAM / VAGINAL	AB	RS	2005-01-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076043-001	TERCONAZOLE	0.4%	CREAM / VAGINAL	AB	RS	2005-01-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076043-001	TERCONAZOLE	0.4%	CREAM / VAGINAL	AB	RS	2005-01-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076043-001	TERCONAZOLE	0.4%	CREAM / VAGINAL	AB	RS	2005-01-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076043-001	TERCONAZOLE	0.4%	CREAM / VAGINAL	AB	RS	2005-01-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076043-001	TERCONAZOLE	0.4%	CREAM / VAGINAL	AB	RS	2005-01-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076043-001	TERCONAZOLE	0.4%	CREAM / VAGINAL	AB	RS	2005-01-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076043-001	TERCONAZOLE	0.4%	CREAM / VAGINAL	AB	RS	2005-01-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076043-001	TERCONAZOLE	0.4%	CREAM / VAGINAL	AB	RS	2005-01-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076043-001	TERCONAZOLE	0.4%	CREAM / VAGINAL	AB	RS	2005-01-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076043-001	TERCONAZOLE	0.4%	CREAM / VAGINAL	AB	RS	2005-01-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076043-001	TERCONAZOLE	0.4%	CREAM / VAGINAL	AB	RS	2005-01-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076043-001	TERCONAZOLE	0.4%	CREAM / VAGINAL	AB	RS	2005-01-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076043-001	TERCONAZOLE	0.4%	CREAM / VAGINAL	AB	RS	2005-01-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076043-001	TERCONAZOLE	0.4%	CREAM / VAGINAL	AB	RS	2005-01-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076043-001	TERCONAZOLE	0.4%	CREAM / VAGINAL	AB	RS	2005-01-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076043-001	TERCONAZOLE	0.4%	CREAM / VAGINAL	AB	RS	2005-01-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076043-001	TERCONAZOLE	0.4%	CREAM / VAGINAL	AB	RS	2005-01-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076043-001	TERCONAZOLE	0.4%	CREAM / VAGINAL	AB	RS	2005-01-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076043-001	TERCONAZOLE	0.4%	CREAM / VAGINAL	AB	RS	2005-01-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076043-001	TERCONAZOLE	0.4%	CREAM / VAGINAL	AB	RS	2005-01-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076043-001	TERCONAZOLE	0.4%	CREAM / VAGINAL	AB	RS	2005-01-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076043-001	TERCONAZOLE	0.4%	CREAM / VAGINAL	AB	RS	2005-01-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076043-001	TERCONAZOLE	0.4%	CREAM / VAGINAL	AB	RS	2005-01-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076043-001	TERCONAZOLE	0.4%	CREAM / VAGINAL	AB	RS	2005-01-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076043-001	TERCONAZOLE	0.4%	CREAM / VAGINAL	AB	RS	2005-01-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076043-001	TERCONAZOLE	0.4%	CREAM / VAGINAL	AB	RS	2005-01-19	`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	A076043-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076043-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076043-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076043-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076043-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076043-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076043-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076043-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076043-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076043-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076043-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076043-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076043-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076043-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076043-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076043-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076043-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076043-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076043-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076043-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076043-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076043-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076043-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076043-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076043-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076043-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076043-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076043-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076043-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076043-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076043-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076043-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076043-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076043-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076043-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076043-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076043-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076043-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076043-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076043-001	AB	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Terconazole	TERCONAZOLE	Sun Pharmaceutical Industries, Inc.	2b3923b5-0a97-428c-b8d2-4a3ceb3447a1	2025-05-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076043 application number: ANDA076043 ndc (product): 51672-1304
Terconazole	TERCONAZOLE	A-S Medication Solutions	b922feb5-cd85-4f13-9a18-913e58f8da83	2023-12-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076043 application number: ANDA076043 ndc (product): 50090-0917

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
21695-844	Terconazole	Terconazole	Rebel Distributors Corp	ANDA	Current
50090-0917	Terconazole	Terconazole	A-S Medication Solutions	ANDA	Current
50090-0917	Terconazole	Terconazole	A-S Medication Solutions	ANDA	Current
50090-0917	Terconazole	Terconazole	A-S Medication Solutions	ANDA	Current
51672-1304	Terconazole	Terconazole	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-1304	Terconazole	Terconazole	Taro Pharmaceuticals U.S.	ANDA	Current
51672-1304	Terconazole	Terconazole	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
53002-8130	Terconazole	Terconazole	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-8130	Terconazole	Terconazole	RPK Pharmaceuticals, Inc.	ANDA	Current