Application 075273

Type: ANDA
Sponsor: TEVA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	KETOCONAZOLE	KETOCONAZOLE	TABLET;ORAL	200MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A075273-001	KETOCONAZOLE	KETOCONAZOLE	200MG	TABLET / ORAL			1999-06-15

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075273-001	KETOCONAZOLE	200MG	TABLET / ORAL	1999-06-15	`f41ea6bd6efb…`

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 3 of 4 · 69 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ketoconazole	KETOCONAZOLE	Zydus Lifesciences Limited	c004ee91-558a-450b-9e4e-d11ab9d28054	2025-03-12		Name fallback brand name: Ketoconazole generic name: KETOCONAZOLE
Ketoconazole	KETOCONAZOLE	Cosette Pharmaceuticals, Inc.	2d7c8dd1-59b5-2645-e063-6394a90a5bda	2025-02-06	Adverse reactions	Name fallback brand name: Ketoconazole generic name: KETOCONAZOLE
Ketoconazole	KETOCONAZOLE CREAM, 2%	NuCare Pharmaceuticals,Inc.	05f9938a-1577-adec-e063-6294a90af349	2025-01-31	Warnings, Adverse reactions	Name fallback brand name: Ketoconazole
Ketoconazole	KETOCONAZOLE	Direct_Rx	f5dc1e67-639f-5476-e053-2995a90a4210	2025-01-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ketoconazole generic name: KETOCONAZOLE
KETOCONAZOLE	KETOCONAZOLE	Direct Rx	bc189ce2-3f10-260d-e053-2a95a90ae808	2025-01-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: KETOCONAZOLE generic name: KETOCONAZOLE
Ketoconazole	KETOCONAZOLE	NuCare Pharmaceuticals,Inc.	570acb82-0c6f-0b98-e054-00144ff8d46c	2024-12-26	Warnings, Adverse reactions	Name fallback brand name: Ketoconazole generic name: KETOCONAZOLE
ketoconazole	KETOCONAZOLE	Bryant Ranch Prepack	ac98307e-315a-4fbd-81cb-cd936f2bfbae	2024-12-24	Warnings, Adverse reactions	Name fallback brand name: ketoconazole generic name: KETOCONAZOLE
Ketodan	KETOCONAZOLE	Medimetriks Pharmaceuticals, Inc.	62f19bd8-926e-4e6b-9097-d81b894b95cc	2024-12-05	Warnings, Adverse reactions	Name fallback generic name: KETOCONAZOLE
ketoconazole	KETOCONAZOLE	Bryant Ranch Prepack	77989858-9f7a-45d6-97fb-deba1cba8fe8	2024-10-08	Warnings, Adverse reactions	Name fallback brand name: ketoconazole generic name: KETOCONAZOLE
ketoconazole	KETOCONAZOLE	Bryant Ranch Prepack	513370d5-2e9f-4677-a0f2-63ff76142909	2024-10-08	Warnings, Adverse reactions	Name fallback brand name: ketoconazole generic name: KETOCONAZOLE
Ketoconazole	KETOCONAZOLE	Bryant Ranch Prepack	d0fcab34-5451-456a-a75a-b1365d5dbc2c	2024-06-20	Adverse reactions	Name fallback brand name: Ketoconazole generic name: KETOCONAZOLE
Ketoconazole	KETOCONAZOLE	Padagis Israel Pharmaceuticals Ltd	99da5233-2760-46f6-8fb3-d9df5da70bfb	2024-05-31	Adverse reactions	Name fallback brand name: Ketoconazole generic name: KETOCONAZOLE
KETOCONAZOLE	KETOCONAZOLE	Bryant Ranch Prepack	3ea8a22b-cd61-4623-a11f-43e3396b50fa	2024-05-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: KETOCONAZOLE generic name: KETOCONAZOLE
Ketoconazole	KETOCONAZOLE	Bryant Ranch Prepack	b200ef76-5ea1-4253-bea5-1e8db0294510	2024-03-15	Adverse reactions	Name fallback brand name: Ketoconazole generic name: KETOCONAZOLE
Ketoconazole	KETOCONAZOLE	Viona Pharmaceuticals Inc	a4bb3f4c-ad93-4d85-b8d0-54eaa62228fd	2024-03-11	Adverse reactions	Name fallback brand name: Ketoconazole generic name: KETOCONAZOLE
Ketoconazole	KETOCONAZOLE CREAM, 2%	Proficient Rx LP	36e0bdcb-845c-452f-ad5a-a116ad657a3a	2024-03-01	Warnings, Adverse reactions	Name fallback brand name: Ketoconazole
ketoconazole	KETOCONAZOLE	Padagis Israel Pharmaceuticals Ltd	9b65f632-a98d-400e-9ec3-84dea581d6a3	2024-02-29	Warnings, Adverse reactions	Name fallback brand name: ketoconazole generic name: KETOCONAZOLE
Ketoconazole	KETOCONAZOLE	Bryant Ranch Prepack	02a348b0-1325-4298-8813-83970da32c7a	2024-01-11	Warnings, Adverse reactions	Name fallback brand name: Ketoconazole generic name: KETOCONAZOLE
Ketoconazole	KETOCONAZOLE	Bryant Ranch Prepack	dc635682-170d-46ad-a9ba-6a75c6e0950e	2024-01-11	Warnings, Adverse reactions	Name fallback brand name: Ketoconazole generic name: KETOCONAZOLE
Ketoconazole	KETOCONAZOLE	A-S Medication Solutions	b3b99c8b-4512-4972-935d-602d4b8325c4	2024-01-08	Warnings, Adverse reactions	Name fallback brand name: Ketoconazole generic name: KETOCONAZOLE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-0900	Ketoconazole	Ketoconazole	Teva Pharmaceuticals USA, Inc.	ANDA	Current
68151-2713	Ketoconazole	Ketoconazole	Carilion Materials Management	ANDA	Current
68788-9117	Ketoconazole	Ketoconazole	Preferred Pharmaceuticals, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
42970	ORIG	1999-06-15
18402	ORIG	1999-06-15
8592	ORIG	1999-06-15