Application 091550

Type: ANDA
Sponsor: PERRIGO ISRAEL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	KETOCONAZOLE	KETOCONAZOLE	AEROSOL, FOAM;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
A091550-001	KETOCONAZOLE	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AB		2011-08-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091550-001	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AB	2011-08-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AB	2011-08-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AB	2011-08-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AB	2011-08-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AB	2011-08-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AB	2011-08-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AB	2011-08-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AB	2011-08-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AB	2011-08-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AB	2011-08-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AB	2011-08-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AB	2011-08-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AB	2011-08-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AB	2011-08-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AB	2011-08-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AB	2011-08-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AB	2011-08-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AB	2011-08-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AT	2011-08-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AB	2011-08-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AB	2011-08-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AT	2011-08-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AT	2011-08-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AT	2011-08-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AT	2011-08-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AT	2011-08-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AT	2011-08-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AT	2011-08-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AB	2011-08-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AB	2011-08-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AB	2011-08-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AB	2011-08-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AB	2011-08-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AB	2011-08-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AB	2011-08-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AB	2011-08-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AB	2011-08-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AB	2011-08-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AB	2011-08-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091550-001	KETOCONAZOLE	2%	AEROSOL, FOAM / TOPICAL	AB	2011-08-25	`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	A091550-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091550-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091550-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091550-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091550-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091550-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091550-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091550-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091550-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091550-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091550-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091550-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091550-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091550-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091550-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091550-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091550-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091550-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091550-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091550-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091550-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091550-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091550-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091550-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091550-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091550-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091550-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091550-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091550-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091550-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091550-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091550-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091550-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091550-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091550-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091550-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091550-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091550-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091550-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091550-001	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	Bryant Ranch Prepack	a878a39d-6d26-4ede-9667-b3e201ffc337	2025-10-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091550 application number: ANDA091550
ketoconazole	KETOCONAZOLE	Bryant Ranch Prepack	65dd4435-99f2-4383-b307-ba5bce9f1ca9	2025-10-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091550 application number: ANDA091550
ketoconazole	KETOCONAZOLE	Bryant Ranch Prepack	ac98307e-315a-4fbd-81cb-cd936f2bfbae	2024-12-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091550 application number: ANDA091550
Ketodan	KETOCONAZOLE	Medimetriks Pharmaceuticals, Inc.	62f19bd8-926e-4e6b-9097-d81b894b95cc	2024-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091550 application number: ANDA091550 ndc (product): 43538-530
ketoconazole	KETOCONAZOLE	Bryant Ranch Prepack	77989858-9f7a-45d6-97fb-deba1cba8fe8	2024-10-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091550 application number: ANDA091550 ndc (product): 63629-8677
ketoconazole	KETOCONAZOLE	Bryant Ranch Prepack	513370d5-2e9f-4677-a0f2-63ff76142909	2024-10-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091550 application number: ANDA091550 ndc (product): 63629-8676
ketoconazole	KETOCONAZOLE	Padagis Israel Pharmaceuticals Ltd	9b65f632-a98d-400e-9ec3-84dea581d6a3	2024-02-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091550 application number: ANDA091550 ndc (product): 45802-532

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 17 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43538-530	Ketodan	ketoconazole	Medimetriks Pharmaceuticals, Inc.	ANDA	Current
43538-530	Ketodan	ketoconazole	Medimetriks Pharmaceuticals, Inc.	ANDA	Current
43538-530	Ketodan	ketoconazole	Medimetriks Pharmaceuticals, Inc.	ANDA	Current
43538-531	Ketodan	ketoconazole	Medimetriks Pharmaceuticals, Inc.	ANDA	Current
43538-531	Ketodan	ketoconazole	Medimetriks Pharmaceuticals, Inc.	ANDA	Current
43538-531	Ketodan	ketoconazole	Medimetriks Pharmaceuticals, Inc.	ANDA	Current
45802-532	ketoconazole	ketoconazole	Perrigo New York Inc	ANDA	Current
45802-532	ketoconazole	ketoconazole	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
45802-532	ketoconazole	ketoconazole	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
45802-532	ketoconazole	ketoconazole	Perrigo New York Inc	ANDA	Current
63629-8676	ketoconazole	ketoconazole	Bryant Ranch Prepack	ANDA	Current
63629-8676	ketoconazole	ketoconazole	Bryant Ranch Prepack	ANDA	Current
63629-8676	ketoconazole	ketoconazole	Bryant Ranch Prepack	ANDA	Current
63629-8677	ketoconazole	ketoconazole	Bryant Ranch Prepack	ANDA	Current
63629-8677	ketoconazole	ketoconazole	Bryant Ranch Prepack	ANDA	Current
63629-8677	ketoconazole	ketoconazole	Bryant Ranch Prepack	ANDA	Current
63629-9421	ketoconazole	ketoconazole	Bryant Ranch Prepack	ANDA	Current