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 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
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 · 43 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
2026-09-14 22:38:34	2026-08	A075597-001	KETOCONAZOLE	200MG	TABLET / ORAL		1999-12-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075597-001	KETOCONAZOLE	200MG	TABLET / ORAL		1999-12-23	`caaa826d4ba7…`
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…`

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 4 of 4 · 69 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ketoconazole	KETOCONAZOLE	A-S Medication Solutions	8ef1117d-0b63-4c26-beaa-7667b2387e14	2023-11-17	Warnings, Adverse reactions	Name fallback brand name: Ketoconazole generic name: KETOCONAZOLE
KETOCONAZOLE	KETOCONAZOLE	A-S Medication Solutions	517c29fc-2a2a-4bd5-a8bb-b464a65d2be0	2023-11-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: KETOCONAZOLE generic name: KETOCONAZOLE
Ketoconazole	KETOCONAZOLE	A-S Medication Solutions	c29d4ddc-aa1c-41c6-99ce-9aff35d213f6	2023-09-25	Adverse reactions	Name fallback brand name: Ketoconazole generic name: KETOCONAZOLE
KETOCONAZOLE	KETOCONAZOLE	Burel Pharmaceuticals, LLC	57e81e13-b395-4dbd-b660-3038de41a838	2023-08-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: KETOCONAZOLE generic name: KETOCONAZOLE
Ketoconazole	KETOCONAZOLE	Proficient Rx LP	cb1908da-443d-40b8-b8c7-b115bc2d37e0	2022-11-01	Adverse reactions	Name fallback brand name: Ketoconazole generic name: KETOCONAZOLE
Ketoconazole	KETOCONAZOLE	Proficient Rx LP	4f08caf2-a57c-4146-9289-532711bbdbcd	2022-04-01	Warnings, Adverse reactions	Name fallback brand name: Ketoconazole generic name: KETOCONAZOLE
Ketoconazole	KETOCONAZOLE	Teva Pharmaceuticals USA, Inc.	7fc47a6a-3714-4598-ae3b-d5a229262c21	2021-09-02	Warnings, Adverse reactions	Name fallback brand name: Ketoconazole generic name: KETOCONAZOLE
Ketoconazole	KETOCONAZOLE	TOLMAR Inc.	7036d1f2-c3f9-41d4-bc72-dd70e1691128	2020-06-03	Adverse reactions	Name fallback brand name: Ketoconazole generic name: KETOCONAZOLE
Ketoconazole	KETOCONAZOLE FOAM	Xiromed, LLC	ea319889-5e58-f778-3009-5ba6a5f2690a	2019-09-23	Warnings, Adverse reactions	Name fallback brand 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 · 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