Application 076942

Type: ANDA
Sponsor: TOLMAR

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	KETOCONAZOLE	KETOCONAZOLE	SHAMPOO;TOPICAL	2%	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
A076942-001	KETOCONAZOLE	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB		2005-04-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076942-001	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 · 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	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076942-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	2005-04-11	`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	A076942-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076942-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076942-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076942-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076942-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076942-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076942-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076942-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076942-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076942-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076942-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076942-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076942-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076942-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076942-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076942-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076942-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076942-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076942-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076942-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076942-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076942-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076942-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076942-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076942-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076942-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076942-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076942-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076942-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076942-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076942-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076942-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076942-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076942-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076942-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076942-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076942-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076942-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076942-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076942-001	AB	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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ketoconazole	KETOCONAZOLE	Preferred Pharmaceuticals Inc.	d59df5bf-bfa6-45fa-81f6-8c8ee2f24cf8	2026-05-14	Adverse reactions	Exact identifier application applno (ANDA): 076942 application number: ANDA076942 ndc (product): 68788-8257
Ketoconazole	KETOCONAZOLE	THIRTY MADISON INC	1f5cd9f4-0db4-4062-b5ec-c33611265e02	2025-12-17	Adverse reactions	Exact identifier application applno (ANDA): 076942 application number: ANDA076942 ndc (product): 71713-097
Ketoconazole	KETOCONAZOLE	Preferred Pharmaceuticals Inc.	39d31bed-9caa-41bb-afdb-25fc18609c14	2025-04-24	Adverse reactions	Exact identifier application applno (ANDA): 076942 application number: ANDA076942
Ketoconazole	KETOCONAZOLE	A-S Medication Solutions	a884bad7-df8c-45de-8c4f-42034b40e425	2025-04-23	Adverse reactions	Exact identifier application applno (ANDA): 076942 application number: ANDA076942
Ketoconazole	KETOCONAZOLE	Cosette Pharmaceuticals, Inc.	2d7c8dd1-59b5-2645-e063-6394a90a5bda	2025-02-06	Adverse reactions	Exact identifier application applno (ANDA): 076942 application number: ANDA076942
Ketoconazole	KETOCONAZOLE	A-S Medication Solutions	c29d4ddc-aa1c-41c6-99ce-9aff35d213f6	2023-09-25	Adverse reactions	Exact identifier application applno (ANDA): 076942 application number: ANDA076942 ndc (product): 50090-3288
Ketoconazole	KETOCONAZOLE	Proficient Rx LP	cb1908da-443d-40b8-b8c7-b115bc2d37e0	2022-11-01	Adverse reactions	Exact identifier application applno (ANDA): 076942 application number: ANDA076942 ndc (product): 71205-105
Ketoconazole	KETOCONAZOLE	TOLMAR Inc.	7036d1f2-c3f9-41d4-bc72-dd70e1691128	2020-06-03	Adverse reactions	Exact identifier application applno (ANDA): 076942 application number: ANDA076942 ndc (product): 63646-010

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-3288	Ketoconazole	Ketoconazole	A-S Medication Solutions	ANDA	Current
50090-3288	Ketoconazole	Ketoconazole	A-S Medication Solutions	ANDA	Current
63646-010	Ketoconazole	Ketoconazole	TOLMAR Inc.	ANDA	Current
63646-010	Ketoconazole	Ketoconazole	TOLMAR Inc.	ANDA	Current
63646-010	Ketoconazole	Ketoconazole	TOLMAR Inc.	ANDA	Current
63646-010	Ketoconazole	Ketoconazole	TOLMAR Inc.	ANDA	Current
68071-1735	Ketoconazole	Ketoconazole	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-1735	Ketoconazole	Ketoconazole	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-1735	Ketoconazole	Ketoconazole	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-8257	Ketoconazole	Ketoconazole	Preferred Pharmaceuticals Inc.	ANDA	Current
71205-105	Ketoconazole	Ketoconazole	Proficient Rx LP	ANDA	Current
71205-105	Ketoconazole	Ketoconazole	Proficient Rx LP	ANDA	Current
71205-105	Ketoconazole	Ketoconazole	Proficient Rx LP	ANDA	Current
71205-105	Ketoconazole	Ketoconazole	Proficient Rx LP	ANDA	Current
71713-097	Ketoconazole	Ketoconazole	THIRTY MADISON INC	ANDA	Current
71713-097	Ketoconazole	Ketoconazole	THIRTY MADISON INC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
43114	ORIG	2007-12-06