Application 077364

Type: ANDA
Sponsor: PERRIGO ISRAEL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CICLOPIROX	CICLOPIROX	CREAM;TOPICAL	0.77%	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
A077364-001	CICLOPIROX	CICLOPIROX	0.77%	CREAM / TOPICAL	AB		2006-03-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077364-001	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	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077364-001	CICLOPIROX	0.77%	CREAM / TOPICAL	AB	2006-03-03	`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	A077364-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077364-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077364-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077364-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077364-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077364-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077364-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077364-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077364-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077364-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077364-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077364-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077364-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077364-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077364-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077364-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077364-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077364-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077364-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077364-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077364-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077364-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077364-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077364-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077364-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077364-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077364-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077364-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077364-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077364-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077364-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077364-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077364-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077364-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077364-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077364-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077364-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077364-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077364-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077364-001	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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ciclopirox Olamine	CICLOPIROX OLAMINE	Bryant Ranch Prepack	6d02fb24-9736-4fe3-b909-1b2172aa2773	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077364 application number: ANDA077364 ndc (product): 63629-8624
Ciclopirox olamine	CICLOPIROX OLAMINE	Bryant Ranch Prepack	74fda3b8-d1f0-4ade-a92a-286f3874f292	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077364 application number: ANDA077364 ndc (product): 63629-8626
Ciclopirox Olamine	CICLOPIROX OLAMINE	Bryant Ranch Prepack	aa326ade-ff55-4355-b6c7-205d6d88d0a3	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077364 application number: ANDA077364 ndc (product): 63629-8625
Ciclopirox olamine	CICLOPIROX OLAMINE	Padagis Israel Pharmaceuticals Ltd	1a74ed86-997a-4b86-b54a-b2b2c94e8abb	2026-04-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077364 application number: ANDA077364 ndc (product): 45802-138
Ciclopirox olamine	CICLOPIROX OLAMINE	Bryant Ranch Prepack	43a7cab8-7921-43bd-8bfa-a9b96f97c94b	2025-10-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077364 application number: ANDA077364
Ciclopirox Olamine	CICLOPIROX OLAMINE	Bryant Ranch Prepack	81e31568-6d87-4d0b-ba52-d2794a7cb023	2025-10-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077364 application number: ANDA077364

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
45802-138	Ciclopirox Olamine	Ciclopirox Olamine	Perrigo New York Inc	ANDA	Current
45802-138	Ciclopirox Olamine	Ciclopirox Olamine	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
49999-646	CICLOPIROX OLAMINE	CICLOPIROX OLAMINE	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
63629-8624	Ciclopirox Olamine	Ciclopirox Olamine	Bryant Ranch Prepack	ANDA	Current
63629-8624	Ciclopirox Olamine	Ciclopirox Olamine	Bryant Ranch Prepack	ANDA	Current
63629-8624	Ciclopirox Olamine	Ciclopirox Olamine	Bryant Ranch Prepack	ANDA	Current
63629-8625	Ciclopirox Olamine	Ciclopirox Olamine	Bryant Ranch Prepack	ANDA	Current
63629-8625	Ciclopirox Olamine	Ciclopirox Olamine	Bryant Ranch Prepack	ANDA	Current
63629-8625	Ciclopirox Olamine	Ciclopirox Olamine	Bryant Ranch Prepack	ANDA	Current
63629-8626	Ciclopirox Olamine	Ciclopirox Olamine	Bryant Ranch Prepack	ANDA	Current
63629-8626	Ciclopirox Olamine	Ciclopirox Olamine	Bryant Ranch Prepack	ANDA	Current
63629-8626	Ciclopirox Olamine	Ciclopirox Olamine	Bryant Ranch Prepack	ANDA	Current