Application 075597

Type: ANDA
Sponsor: MYLAN

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 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
A075597-001	KETOCONAZOLE	KETOCONAZOLE	200MG	TABLET / ORAL			1999-12-23

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	A075597-001	KETOCONAZOLE	200MG	TABLET / ORAL		1999-12-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075597-001	KETOCONAZOLE	200MG	TABLET / ORAL		1999-12-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075597-001	KETOCONAZOLE	200MG	TABLET / ORAL		1999-12-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075597-001	KETOCONAZOLE	200MG	TABLET / ORAL		1999-12-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075597-001	KETOCONAZOLE	200MG	TABLET / ORAL		1999-12-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075597-001	KETOCONAZOLE	200MG	TABLET / ORAL		1999-12-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075597-001	KETOCONAZOLE	200MG	TABLET / ORAL		1999-12-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075597-001	KETOCONAZOLE	200MG	TABLET / ORAL		1999-12-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075597-001	KETOCONAZOLE	200MG	TABLET / ORAL		1999-12-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075597-001	KETOCONAZOLE	200MG	TABLET / ORAL		1999-12-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075597-001	KETOCONAZOLE	200MG	TABLET / ORAL		1999-12-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075597-001	KETOCONAZOLE	200MG	TABLET / ORAL		1999-12-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075597-001	KETOCONAZOLE	200MG	TABLET / ORAL		1999-12-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075597-001	KETOCONAZOLE	200MG	TABLET / ORAL		1999-12-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075597-001	KETOCONAZOLE	200MG	TABLET / ORAL		1999-12-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075597-001	KETOCONAZOLE	200MG	TABLET / ORAL		1999-12-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075597-001	KETOCONAZOLE	200MG	TABLET / ORAL		1999-12-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075597-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	1999-12-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075597-001	KETOCONAZOLE	200MG	TABLET / ORAL		1999-12-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075597-001	KETOCONAZOLE	200MG	TABLET / ORAL		1999-12-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075597-001	KETOCONAZOLE	200MG	TABLET / ORAL		1999-12-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075597-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	1999-12-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075597-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	1999-12-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075597-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	1999-12-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075597-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	1999-12-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075597-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	1999-12-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075597-001	KETOCONAZOLE	200MG	TABLET / ORAL	AB	1999-12-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075597-001	KETOCONAZOLE	200MG	TABLET / ORAL		1999-12-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075597-001	KETOCONAZOLE	200MG	TABLET / ORAL		1999-12-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075597-001	KETOCONAZOLE	200MG	TABLET / ORAL		1999-12-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075597-001	KETOCONAZOLE	200MG	TABLET / ORAL		1999-12-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075597-001	KETOCONAZOLE	200MG	TABLET / ORAL		1999-12-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075597-001	KETOCONAZOLE	200MG	TABLET / ORAL		1999-12-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075597-001	KETOCONAZOLE	200MG	TABLET / ORAL		1999-12-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075597-001	KETOCONAZOLE	200MG	TABLET / ORAL		1999-12-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075597-001	KETOCONAZOLE	200MG	TABLET / ORAL		1999-12-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075597-001	KETOCONAZOLE	200MG	TABLET / ORAL		1999-12-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075597-001	KETOCONAZOLE	200MG	TABLET / ORAL		1999-12-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075597-001	KETOCONAZOLE	200MG	TABLET / ORAL		1999-12-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075597-001	KETOCONAZOLE	200MG	TABLET / ORAL		1999-12-23	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A075597-001	AB	1	`74a2ff9319b5…`
2021-03-12 10:30 UTC	2021-03	A075597-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075597-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075597-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075597-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075597-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075597-001	AB	1	`ea99ee380514…`

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 4 · 66 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gemachlich ZuHause Ketoconazole 1% Anti-dandruff Shampoos	KETOCONAZOLE	Guangzhou Xinhongda Trading Service Co., Ltd.	5792eff5-632e-3664-e063-6394a90a8ae3	2026-07-27	Warnings	Name fallback generic name: KETOCONAZOLE
KETOCONAZOLE	KETOCONAZOLE	PD-Rx Pharmaceuticals, Inc.	f162e616-21b4-49b1-b437-15e21001a6f0	2026-07-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: KETOCONAZOLE generic name: KETOCONAZOLE
Cysndra Ketoconazole 1% Medicated Shampoos	KETOCONAZOLE	Guangzhou Xinhongda Trading Service Co., Ltd.	55ee7358-dfc1-b600-e063-6394a90a49d8	2026-07-06	Warnings	Name fallback generic name: KETOCONAZOLE
Anti Dandruff	KETOCONAZOLE	Guangzhou ChuanMa International Trading Co.,Ltd.	4cfe234c-49c0-18e8-e063-6294a90a0b1d	2026-07-02	Warnings	Name fallback generic name: KETOCONAZOLE
Anti-Dandruff	KETOCONAZOLE	Guangzhou ChuanMa International Trading Co.,Ltd.	543a431f-21fb-df9e-e063-6394a90a6c36	2026-06-14	Warnings	Name fallback generic name: KETOCONAZOLE
Ketoconazole	KETOCONAZOLE	NuCare Pharmaceuticals, Inc.	53492ad1-baca-a7f6-e063-6294a90a2990	2026-06-02	Adverse reactions	Name fallback brand name: Ketoconazole generic name: KETOCONAZOLE
Ketoconazole	KETOCONAZOLE	Preferred Pharmaceuticals Inc.	d59df5bf-bfa6-45fa-81f6-8c8ee2f24cf8	2026-05-14	Adverse reactions	Name fallback brand name: Ketoconazole generic name: KETOCONAZOLE
Ketoconazole	KETOCONAZOLE CREAM, 2%	Preferred Pharmaceuticals Inc.	abc2446c-cdc2-48fe-80f2-cf0038d2a85e	2026-05-14	Warnings, Adverse reactions	Name fallback brand name: Ketoconazole
Nizoral	KETOCONAZOLE	Kramer Laboratories	a17b7424-ee7e-4fcc-b6b3-0904932ae319	2026-03-17	Warnings	Name fallback generic name: KETOCONAZOLE
Gembooxt Ketoconazole 1% Medicated Shampoos	KETOCONAZOLE	Guangdong Quadrant Ecological Technology Co., Ltd.	49965e91-43c3-65d7-e063-6294a90abaec	2026-01-30	Warnings	Name fallback generic name: KETOCONAZOLE
Ketoconazole	KETOCONAZOLE	ANI Pharmaceuticals, Inc.	00c1cac8-a865-4583-aaba-3a0f21fb31e6	2026-01-29	Adverse reactions	Name fallback brand name: Ketoconazole generic name: KETOCONAZOLE
ketoconazole	KETOCONAZOLE	E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC	cad7c647-34a9-4e4e-83b3-8d78e58f588f	2026-01-28	Warnings, Adverse reactions	Name fallback brand name: ketoconazole generic name: KETOCONAZOLE
Ketoconazole	KETOCONAZOLE	NORTHSTAR RX LLC	bf3e48fd-e063-42e6-acd1-580ddc6e93be	2026-01-26	Warnings, Adverse reactions	Name fallback brand name: Ketoconazole generic name: KETOCONAZOLE
Ketoconazole	KETOCONAZOLE CREAM, 2%	ASCLEMED USA INC.	6f1a5365-99df-4169-9382-14c2643e561d	2026-01-23	Warnings, Adverse reactions	Name fallback brand name: Ketoconazole
Ketoconazole	KETOCONAZOLE CREAM, 2%	Sportpharm LLC	d68f090d-82ea-413f-ab76-9254a8888736	2026-01-19	Warnings, Adverse reactions	Name fallback brand name: Ketoconazole
Ketoconazole	KETOCONAZOLE	THIRTY MADISON INC	1f5cd9f4-0db4-4062-b5ec-c33611265e02	2025-12-17	Adverse reactions	Name fallback brand name: Ketoconazole generic name: KETOCONAZOLE
KETOCONAZOLE	KETOCONAZOLE	Strides Pharma Science Limited	6d4be760-c723-4f54-a854-12c61cf91703	2025-12-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: KETOCONAZOLE generic name: KETOCONAZOLE
Ketoconazole	KETOCONAZOLE	NuCare Pharmaceuticals,Inc.	4578c84a-d438-6740-e063-6294a90a0151	2025-12-08	Adverse reactions	Name fallback brand name: Ketoconazole generic name: KETOCONAZOLE
Ketoconazole	KETOCONAZOLE	Northstar Rx LLC	c4f711dc-d0ea-4beb-9a78-b7e3594ee4be	2025-12-01	Adverse reactions	Name fallback brand name: Ketoconazole generic name: KETOCONAZOLE
Ketoconazole	KETOCONAZOLE	Bryant Ranch Prepack	4baebcab-a237-42c0-9183-6f447a44e371	2025-11-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ketoconazole generic name: KETOCONAZOLE

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
0378-0261	Ketoconazole	ketoconazole	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-0261	Ketoconazole	ketoconazole	Mylan Pharmaceuticals Inc.	ANDA	Current
43063-036	Ketoconazole	ketoconazole	PD-Rx Pharmaceuticals, In	ANDA	Current
43063-036	Ketoconazole	ketoconazole	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-036	Ketoconazole	ketoconazole	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
50090-1992	Ketoconazole	ketoconazole	A-S Medication Solutions	ANDA	Current
53808-0842	Ketoconazole	ketoconazole	State of Florida DOH Central Pharmacy	ANDA	Current
68084-552	Ketoconazole	ketoconazole	American Health Packaging	ANDA	Current
70518-2027	Ketoconazole	ketoconazole	REMEDYREPACK INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8732	ORIG	1999-12-23