Application 076419

Type: ANDA
Sponsor: PERRIGO ISRAEL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	KETOCONAZOLE	KETOCONAZOLE	SHAMPOO;TOPICAL	2%	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A076419-001	KETOCONAZOLE	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	RS	2004-01-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076419-001	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 · 42 observed 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
2026-08-18 06:07:40	2026-07	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	RS	2004-01-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	RS	2004-01-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	RS	2004-01-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	RS	2004-01-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	RS	2004-01-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	RS	2004-01-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	RS	2004-01-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	RS	2004-01-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	RS	2004-01-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	RS	2004-01-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	RS	2004-01-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	RS	2004-01-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	RS	2004-01-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	RS	2004-01-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	RS	2004-01-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	RS	2004-01-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	RS	2004-01-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	RS	2004-01-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB		2004-01-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	RS	2004-01-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	RS	2004-01-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	RS	2004-01-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	RS	2004-01-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	RS	2004-01-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB		2004-01-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB		2004-01-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB		2004-01-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB		2004-01-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	RS	2004-01-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	RS	2004-01-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	RS	2004-01-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	RS	2004-01-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	RS	2004-01-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	RS	2004-01-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	RS	2004-01-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	RS	2004-01-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	RS	2004-01-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	RS	2004-01-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	RS	2004-01-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076419-001	KETOCONAZOLE	2%	SHAMPOO / TOPICAL	AB	RS	2004-01-07	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A076419-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076419-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076419-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076419-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076419-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076419-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076419-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076419-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076419-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076419-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076419-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076419-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076419-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076419-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076419-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076419-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076419-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076419-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076419-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076419-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076419-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076419-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076419-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076419-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076419-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076419-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076419-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076419-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076419-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076419-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076419-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076419-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076419-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076419-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076419-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076419-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076419-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076419-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076419-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076419-001	AB	1	`e64feba35796…`

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ketoconazole	KETOCONAZOLE	NuCare Pharmaceuticals, Inc.	53492ad1-baca-a7f6-e063-6294a90a2990	2026-06-02	Adverse reactions	Exact identifier application applno (ANDA): 076419 application number: ANDA076419
Ketoconazole	KETOCONAZOLE	NuCare Pharmaceuticals,Inc.	4578c84a-d438-6740-e063-6294a90a0151	2025-12-08	Adverse reactions	Exact identifier application applno (ANDA): 076419 application number: ANDA076419
Ketoconazole	KETOCONAZOLE	Northstar Rx LLC	c4f711dc-d0ea-4beb-9a78-b7e3594ee4be	2025-12-01	Adverse reactions	Exact identifier application applno (ANDA): 076419 application number: ANDA076419
Ketoconazole	KETOCONAZOLE	Bryant Ranch Prepack	6d394f8c-d49e-45ff-b7a9-a14aba9bb9cf	2025-10-24	Adverse reactions	Exact identifier application applno (ANDA): 076419 application number: ANDA076419
Ketoconazole	KETOCONAZOLE	Bryant Ranch Prepack	d0fcab34-5451-456a-a75a-b1365d5dbc2c	2024-06-20	Adverse reactions	Exact identifier application applno (ANDA): 076419 application number: ANDA076419
Ketoconazole	KETOCONAZOLE	Padagis Israel Pharmaceuticals Ltd	99da5233-2760-46f6-8fb3-d9df5da70bfb	2024-05-31	Adverse reactions	Exact identifier application applno (ANDA): 076419 application number: ANDA076419 ndc (product): 45802-465
Ketoconazole	KETOCONAZOLE	Bryant Ranch Prepack	b200ef76-5ea1-4253-bea5-1e8db0294510	2024-03-15	Adverse reactions	Exact identifier application applno (ANDA): 076419 application number: ANDA076419 ndc (product): 63629-8675

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
45802-465	Ketoconazole	Ketoconazole	Perrigo New York Inc	ANDA	Current
45802-465	Ketoconazole	Ketoconazole	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
50090-1220	Ketoconazole	Ketoconazole	A-S Medication Solutions	ANDA	Current
50090-1220	Ketoconazole	Ketoconazole	A-S Medication Solutions	ANDA	Current
50090-1220	Ketoconazole	Ketoconazole	A-S Medication Solutions	ANDA	Current
53217-015	Ketoconazole	Ketoconazole	Aidarex Pharmaceuticals LLC	ANDA	Current
63629-8675	Ketoconazole	Ketoconazole	Bryant Ranch Prepack	ANDA	Current
63629-8675	Ketoconazole	Ketoconazole	Bryant Ranch Prepack	ANDA	Current
63629-8675	Ketoconazole	Ketoconazole	Bryant Ranch Prepack	ANDA	Current
68788-9903	Ketoconazole	Ketoconazole	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9903	Ketoconazole	Ketoconazole	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9903	Ketoconazole	Ketoconazole	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9903	Ketoconazole	Ketoconazole	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9903	Ketoconazole	Ketoconazole	Preferred Pharmaceuticals, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
43075	ORIG	2007-04-02