Application 212443

Type: ANDA
Sponsor: ENCUBE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	KETOCONAZOLE	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
A212443-001	KETOCONAZOLE	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2021-05-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212443-001	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.

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
2026-02-19 14:30 UTC	2026-02	A212443-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2021-05-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212443-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2021-05-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212443-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB		2021-05-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212443-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB		2021-05-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212443-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB		2021-05-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212443-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB		2021-05-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212443-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB		2021-05-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212443-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB		2021-05-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212443-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB		2021-05-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212443-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB		2021-05-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212443-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB		2021-05-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212443-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB		2021-05-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212443-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB		2021-05-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212443-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB		2021-05-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212443-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB		2021-05-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212443-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB		2021-05-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212443-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB		2021-05-20	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212443-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB		2021-05-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212443-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB		2021-05-20	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212443-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB		2021-05-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212443-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB		2021-05-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212443-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB		2021-05-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212443-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB		2021-05-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212443-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB		2021-05-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212443-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB		2021-05-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212443-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB		2021-05-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212443-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB		2021-05-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212443-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB		2021-05-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212443-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB		2021-05-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212443-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB		2021-05-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212443-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB		2021-05-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212443-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB		2021-05-20	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212443-001	KETOCONAZOLE	2%	CREAM / TOPICAL	AB	RS	2021-05-20	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A212443-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212443-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212443-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212443-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212443-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212443-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212443-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212443-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212443-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212443-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212443-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212443-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212443-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212443-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212443-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212443-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212443-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212443-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212443-001	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212443-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212443-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212443-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212443-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212443-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212443-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212443-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212443-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212443-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212443-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212443-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212443-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212443-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212443-001	AB	1	`a50c72e98297…`

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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ketoconazole	KETOCONAZOLE CREAM, 2%	Preferred Pharmaceuticals Inc.	abc2446c-cdc2-48fe-80f2-cf0038d2a85e	2026-05-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212443 application number: ANDA212443 ndc (product): 68788-8233
Ketoconazole Cream	KETOCONAZOLE CREAM	Direct_Rx	f422aaa8-3cce-5989-e053-2a95a90a5205	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212443 application number: ANDA212443
Ketoconazole	KETOCONAZOLE CREAM, 2%	ASCLEMED USA INC.	6f1a5365-99df-4169-9382-14c2643e561d	2026-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212443 application number: ANDA212443
Ketoconazole	KETOCONAZOLE CREAM, 2%	Sportpharm LLC	d68f090d-82ea-413f-ab76-9254a8888736	2026-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212443 application number: ANDA212443
Ketoconazole	KETOCONAZOLE CREAM, 2%	REMEDYREPACK INC.	ea56cddf-94c9-46b6-8791-995b741cfbd7	2025-09-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212443 application number: ANDA212443
Ketoconazole	KETOCONAZOLE CREAM, 2%	Encube Ethicals, Inc.	59188ef7-5bc9-4acc-bbff-8712c41e5f77	2025-09-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212443 application number: ANDA212443 ndc (product): 21922-025
Ketoconazole	KETOCONAZOLE CREAM, 2%	A-S Medication Solutions	750bcfc3-b0e4-407e-ad12-e81b183f3b00	2025-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212443 application number: ANDA212443 ndc (product): 50090-6046
Ketoconazole	KETOCONAZOLE CREAM, 2%	NuCare Pharmaceuticals,Inc.	05f9938a-1577-adec-e063-6294a90af349	2025-01-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212443 application number: ANDA212443
Ketoconazole	KETOCONAZOLE CREAM, 2%	Proficient Rx LP	36e0bdcb-845c-452f-ad5a-a116ad657a3a	2024-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212443 application number: ANDA212443

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
21922-025	Ketoconazole	Ketoconazole Cream, 2%	Encube Ethicals Private Limited	ANDA	Current
50090-6046	Ketoconazole	Ketoconazole Cream, 2%	A-S Medication Solutions	ANDA	Current
68071-2847	Ketoconazole	Ketoconazole Cream, 2%	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-8233	Ketoconazole	Ketoconazole Cream, 2%	Preferred Pharmaceuticals Inc.	ANDA	Current