Application 077676

Type: ANDA
Sponsor: PERRIGO NEW YORK

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CICLOPIROX	CICLOPIROX	SUSPENSION;TOPICAL	0.77%	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
A077676-001	CICLOPIROX	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB		2006-12-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077676-001	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 · 41 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
2026-02-19 14:30 UTC	2026-02	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077676-001	CICLOPIROX	0.77%	SUSPENSION / TOPICAL	AB	2006-12-15	`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	A077676-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077676-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077676-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077676-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077676-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077676-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077676-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077676-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077676-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077676-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077676-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077676-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077676-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077676-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077676-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077676-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077676-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077676-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077676-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077676-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077676-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077676-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077676-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077676-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077676-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077676-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077676-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077676-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077676-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077676-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077676-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077676-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077676-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077676-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077676-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077676-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077676-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077676-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077676-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077676-001	AB	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 · 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	835a6370-f331-4b15-b6fa-beafe027f187	2025-10-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077676 application number: ANDA077676
Ciclopirox Olamine	CICLOPIROX OLAMINE	Bryant Ranch Prepack	9130e3c7-566b-411b-b54d-c894e9094b5b	2025-07-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077676 application number: ANDA077676
Ciclopirox Olamine	CICLOPIROX OLAMINE	Padagis Israel Pharmaceuticals Ltd	eadbd29d-5990-4987-833f-40cd0b2d2868	2025-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077676 application number: ANDA077676 ndc (product): 45802-400
Ciclopirox Olamine	CICLOPIROX OLAMINE	Bryant Ranch Prepack	29c638cd-b6cb-4e17-8cb3-636253a2e47c	2025-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077676 application number: ANDA077676 ndc (product): 63629-8627
Ciclopirox Olamine	CICLOPIROX OLAMINE	Bryant Ranch Prepack	246585a0-e53e-4f54-8f8b-76536011ab23	2025-01-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077676 application number: ANDA077676 ndc (product): 63629-2522
Ciclopirox Olamine	CICLOPIROX OLAMINE	Bryant Ranch Prepack	399fd2d5-f5a2-4bce-ad4e-ce70060a14b0	2024-12-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077676 application number: ANDA077676

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
45802-400	Ciclopirox Olamine	Ciclopirox Olamine	Perrigo New York Inc	ANDA	Current
45802-400	Ciclopirox Olamine	Ciclopirox Olamine	Perrigo New York Inc	ANDA	Current
45802-400	Ciclopirox Olamine	Ciclopirox Olamine	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
63629-2522	Ciclopirox Olamine	Ciclopirox Olamine	Bryant Ranch Prepack	ANDA	Current
63629-2522	Ciclopirox Olamine	Ciclopirox Olamine	Bryant Ranch Prepack	ANDA	Current
63629-2522	Ciclopirox Olamine	Ciclopirox Olamine	Bryant Ranch Prepack	ANDA	Current
63629-8627	Ciclopirox Olamine	Ciclopirox Olamine	Bryant Ranch Prepack	ANDA	Current
63629-8627	Ciclopirox Olamine	Ciclopirox Olamine	Bryant Ranch Prepack	ANDA	Current
63629-8627	Ciclopirox Olamine	Ciclopirox Olamine	Bryant Ranch Prepack	ANDA	Current