Application 075638

Type: ANDA
Sponsor: TARO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	KETOZOLE	KETOCONAZOLE	CREAM;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
A075638-001	KETOZOLE	KETOCONAZOLE	2%	CREAM / TOPICAL	AB		2002-12-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075638-001	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	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075638-001	KETOZOLE	2%	CREAM / TOPICAL	AB	2002-12-18	`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	A075638-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075638-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075638-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075638-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075638-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075638-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075638-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075638-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075638-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075638-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075638-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075638-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075638-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075638-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075638-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075638-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075638-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075638-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075638-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075638-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075638-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075638-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075638-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075638-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075638-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075638-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075638-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075638-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075638-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075638-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075638-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075638-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075638-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075638-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075638-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075638-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075638-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075638-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075638-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075638-001	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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ketoconazole	KETOCONAZOLE	NORTHSTAR RX LLC	bf3e48fd-e063-42e6-acd1-580ddc6e93be	2026-01-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075638 application number: ANDA075638 ndc (product): 16714-955
Ketoconazole	KETOCONAZOLE	Golden State Medical Supply, Inc.	3e3cde4b-939f-4837-9920-bb6bb8416bd6	2025-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075638 application number: ANDA075638 ndc (product): 51407-279
Ketoconazole	KETOCONAZOLE	Sun Pharmaceutical Industries, Inc.	39b85d6a-9133-42e6-b7f8-58f045e9b9f0	2025-07-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075638 application number: ANDA075638 ndc (product): 51672-1298
Ketoconazole	KETOCONAZOLE	NuCare Pharmaceuticals,Inc.	570acb82-0c6f-0b98-e054-00144ff8d46c	2024-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075638 application number: ANDA075638 ndc (product): 68071-1709
Ketoconazole	KETOCONAZOLE	A-S Medication Solutions	8ef1117d-0b63-4c26-beaa-7667b2387e14	2023-11-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075638 application number: ANDA075638 ndc (product): 50090-6069
Ketoconazole	KETOCONAZOLE	Proficient Rx LP	4f08caf2-a57c-4146-9289-532711bbdbcd	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075638 application number: ANDA075638 ndc (product): 63187-774

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 39 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-955	Ketoconazole	Ketoconazole	NORTHSTAR RX LLC	ANDA	Current
21695-554	Ketoconazole	Ketoconazole	Rebel Distributors Corp	ANDA	Current
21695-555	Ketoconazole	Ketoconazole	Rebel Distributors Corp	ANDA	Current
21695-556	Ketoconazole	Ketoconazole	Rebel Distributors Corp	ANDA	Current
50090-1524	Ketoconazole	Ketoconazole	A-S Medication Solutions	ANDA	Current
50090-1524	Ketoconazole	Ketoconazole	A-S Medication Solutions	ANDA	Current
50090-1524	Ketoconazole	Ketoconazole	A-S Medication Solutions	ANDA	Current
50090-1675	Ketoconazole	Ketoconazole	A-S Medication Solutions	ANDA	Current
50090-1675	Ketoconazole	Ketoconazole	A-S Medication Solutions	ANDA	Current
50090-1675	Ketoconazole	Ketoconazole	A-S Medication Solutions	ANDA	Current
50090-6069	Ketoconazole	Ketoconazole	A-S Medication Solutions	ANDA	Current
51407-279	Ketoconazole	Ketoconazole	Golden State Medical Supply, Inc.	ANDA	Current
51672-1298	Ketoconazole	Ketoconazole	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
53002-8150	Ketoconazole	Ketoconazole	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-8150	Ketoconazole	Ketoconazole	RPK Pharmaceuticals, Inc.	ANDA	Current
63187-774	Ketoconazole	Ketoconazole	Proficient Rx LP	ANDA	Current
63187-774	Ketoconazole	Ketoconazole	Proficient Rx LP	ANDA	Current
63187-774	Ketoconazole	Ketoconazole	Proficient Rx LP	ANDA	Current
63187-774	Ketoconazole	Ketoconazole	Proficient Rx LP	ANDA	Current
68071-1614	Ketoconazole	Ketoconazole	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-1614	Ketoconazole	Ketoconazole	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-1614	Ketoconazole	Ketoconazole	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-1709	Ketoconazole	Ketoconazole	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-1709	Ketoconazole	Ketoconazole	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-1709	Ketoconazole	Ketoconazole	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-1743	Ketoconazole	Ketoconazole	NuCare Pharmaceuticals,Inc.	ANDA	Current
68258-3998	Ketoconazole	Ketoconazole	Dispensing Solutions, Inc.	ANDA	Current
68788-9915	Ketoconazole	Ketoconazole	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9915	Ketoconazole	Ketoconazole	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9915	Ketoconazole	Ketoconazole	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9915	Ketoconazole	Ketoconazole	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9915	Ketoconazole	Ketoconazole	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-0762	Ketoconazole	Ketoconazole	REMEDYREPACK INC.	ANDA	Current
70518-0762	Ketoconazole	Ketoconazole	REMEDYREPACK INC.	ANDA	Current
70518-0762	Ketoconazole	Ketoconazole	REMEDYREPACK INC.	ANDA	Current
70518-0762	Ketoconazole	Ketoconazole	REMEDYREPACK INC.	ANDA	Current
70859-053	PedizolPAK	Ketoconazole,Miconazole Nitrate	NuCare Pharmaceuticals,Inc.	ANDA	Current
70859-053	PedizolPAK	Ketoconazole,Miconazole Nitrate	NuCare Pharmaceuticals,Inc.	ANDA	Current
71085-008	Ketoconazole	Ketoconazole	IPG PHARMACEUTICALS, INC.	ANDA	Current