Application 077623

Type: ANDA
Sponsor: PERRIGO NEW YORK

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CICLOPIROX	CICLOPIROX	SOLUTION;TOPICAL	8%	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
A077623-001	CICLOPIROX	CICLOPIROX	8%	SOLUTION / TOPICAL	AT	RS	2007-09-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077623-001	AT

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT	RS	2007-09-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT	RS	2007-09-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT	RS	2007-09-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT	RS	2007-09-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT	RS	2007-09-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT	RS	2007-09-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT	RS	2007-09-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT	RS	2007-09-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT	RS	2007-09-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT	RS	2007-09-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT	RS	2007-09-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT	RS	2007-09-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT	RS	2007-09-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT	RS	2007-09-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT		2007-09-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT		2007-09-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT		2007-09-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT		2007-09-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT		2007-09-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT		2007-09-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT		2007-09-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT		2007-09-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT		2007-09-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT		2007-09-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT		2007-09-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT		2007-09-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT		2007-09-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT	RS	2007-09-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT	RS	2007-09-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT	RS	2007-09-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT	RS	2007-09-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT	RS	2007-09-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT	RS	2007-09-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT	RS	2007-09-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT	RS	2007-09-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT		2007-09-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT		2007-09-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT		2007-09-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT		2007-09-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077623-001	CICLOPIROX	8%	SOLUTION / TOPICAL	AT		2007-09-18	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077623-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077623-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077623-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077623-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077623-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077623-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077623-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077623-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077623-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077623-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077623-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077623-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077623-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077623-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077623-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077623-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077623-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077623-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077623-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077623-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077623-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077623-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077623-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077623-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077623-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077623-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077623-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077623-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077623-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077623-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077623-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077623-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077623-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077623-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077623-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077623-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077623-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077623-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077623-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077623-001	AT	1	`cb3db0bc1861…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ciclopirox	CICLOPIROX	Bryant Ranch Prepack	d7e22682-1485-47e5-b6ae-94534bd3d889	2026-06-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077623 application number: ANDA077623
Ciclopirox	CICLOPIROX	Preferred Pharmaceuticals, Inc.	efcd78c0-2426-4fcc-a1c8-527e4e6f99d3	2026-03-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077623 application number: ANDA077623 ndc (product): 68788-6797
Ciclopirox	CICLOPIROX	Bryant Ranch Prepack	9c7d1fd9-71dd-4bbb-aed2-7db5cffa8b5a	2023-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077623 application number: ANDA077623 ndc (product): 63629-8623
Ciclopirox	CICLOPIROX	Padagis Israel Pharmaceuticals Ltd	02f46b6e-b424-4210-83bf-e79618df4344	2023-01-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077623 application number: ANDA077623 ndc (product): 45802-141

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
45802-141	Ciclopirox	Ciclopirox	Perrigo New York Inc	ANDA	Current
45802-141	Ciclopirox	Ciclopirox	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
45802-141	Ciclopirox	Ciclopirox	Perrigo New York Inc	ANDA	Current
63629-8623	Ciclopirox	Ciclopirox	Bryant Ranch Prepack	ANDA	Current
63629-8623	Ciclopirox	Ciclopirox	Bryant Ranch Prepack	ANDA	Current
68071-1524	Ciclopirox	Ciclopirox	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-1524	Ciclopirox	Ciclopirox	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-6797	Ciclopirox	Ciclopirox	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-6797	Ciclopirox	Ciclopirox	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-6797	Ciclopirox	Ciclopirox	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-6797	Ciclopirox	Ciclopirox	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-6797	Ciclopirox	Ciclopirox	Preferred Pharmaceuticals, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31266	ORIG	2007-09-25