Application 021159

Type: NDA
Sponsor: BAUSCH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LOPROX	CICLOPIROX	SHAMPOO;TOPICAL	1%	Yes	Yes

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
N021159-001	LOPROX	CICLOPIROX	1%	SHAMPOO / TOPICAL		RLD	2003-02-28

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	N021159-001	LOPROX	1%	SHAMPOO / TOPICAL		RLD	2003-02-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021159-001	LOPROX	1%	SHAMPOO / TOPICAL		RLD	2003-02-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021159-001	LOPROX	1%	SHAMPOO / TOPICAL		RLD	2003-02-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021159-001	LOPROX	1%	SHAMPOO / TOPICAL	AT	RLD, RS	2003-02-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021159-001	LOPROX	1%	SHAMPOO / TOPICAL	AT	RLD, RS	2003-02-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021159-001	LOPROX	1%	SHAMPOO / TOPICAL	AT	RLD, RS	2003-02-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021159-001	LOPROX	1%	SHAMPOO / TOPICAL	AT	RLD, RS	2003-02-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021159-001	LOPROX	1%	SHAMPOO / TOPICAL	AT	RLD, RS	2003-02-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021159-001	LOPROX	1%	SHAMPOO / TOPICAL	AT	RLD, RS	2003-02-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021159-001	LOPROX	1%	SHAMPOO / TOPICAL	AT	RLD, RS	2003-02-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021159-001	LOPROX	1%	SHAMPOO / TOPICAL	AT	RLD, RS	2003-02-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021159-001	LOPROX	1%	SHAMPOO / TOPICAL	AT	RLD, RS	2003-02-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021159-001	LOPROX	1%	SHAMPOO / TOPICAL	AT	RLD, RS	2003-02-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021159-001	LOPROX	1%	SHAMPOO / TOPICAL	AT	RLD, RS	2003-02-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021159-001	LOPROX	1%	SHAMPOO / TOPICAL	AT	RLD, RS	2003-02-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021159-001	LOPROX	1%	SHAMPOO / TOPICAL	AT	RLD, RS	2003-02-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021159-001	LOPROX	1%	SHAMPOO / TOPICAL	AT	RLD, RS	2003-02-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021159-001	LOPROX	1%	SHAMPOO / TOPICAL	AT	RLD, RS	2003-02-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021159-001	LOPROX	1%	SHAMPOO / TOPICAL	AT	RLD, RS	2003-02-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021159-001	LOPROX	1%	SHAMPOO / TOPICAL	AT	RLD, RS	2003-02-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021159-001	LOPROX	1%	SHAMPOO / TOPICAL	AT	RLD, RS	2003-02-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021159-001	LOPROX	1%	SHAMPOO / TOPICAL	AT	RLD, RS	2003-02-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021159-001	LOPROX	1%	SHAMPOO / TOPICAL	AT	RLD, RS	2003-02-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021159-001	LOPROX	1%	SHAMPOO / TOPICAL	AT	RLD, RS	2003-02-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021159-001	LOPROX	1%	SHAMPOO / TOPICAL	AT	RLD, RS	2003-02-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021159-001	LOPROX	1%	SHAMPOO / TOPICAL	AT	RLD, RS	2003-02-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021159-001	LOPROX	1%	SHAMPOO / TOPICAL	AT	RLD, RS	2003-02-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021159-001	LOPROX	1%	SHAMPOO / TOPICAL	AT	RLD, RS	2003-02-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021159-001	LOPROX	1%	SHAMPOO / TOPICAL	AT	RLD, RS	2003-02-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021159-001	LOPROX	1%	SHAMPOO / TOPICAL	AT	RLD, RS	2003-02-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021159-001	LOPROX	1%	SHAMPOO / TOPICAL	AT	RLD, RS	2003-02-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021159-001	LOPROX	1%	SHAMPOO / TOPICAL	AT	RLD, RS	2003-02-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021159-001	LOPROX	1%	SHAMPOO / TOPICAL	AT	RLD, RS	2003-02-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021159-001	LOPROX	1%	SHAMPOO / TOPICAL	AT	RLD, RS	2003-02-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021159-001	LOPROX	1%	SHAMPOO / TOPICAL	AT	RLD, RS	2003-02-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021159-001	LOPROX	1%	SHAMPOO / TOPICAL	AT	RLD, RS	2003-02-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021159-001	LOPROX	1%	SHAMPOO / TOPICAL	AT	RLD, RS	2003-02-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021159-001	LOPROX	1%	SHAMPOO / TOPICAL	AT	RLD, RS	2003-02-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021159-001	LOPROX	1%	SHAMPOO / TOPICAL	AT	RLD, RS	2003-02-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021159-001	LOPROX	1%	SHAMPOO / TOPICAL	AT	RLD, RS	2003-02-28	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021159-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021159-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021159-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021159-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021159-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021159-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021159-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021159-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021159-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021159-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021159-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021159-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021159-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021159-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021159-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021159-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021159-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021159-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021159-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021159-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021159-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021159-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021159-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021159-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021159-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021159-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021159-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021159-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021159-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021159-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021159-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021159-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021159-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021159-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021159-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021159-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021159-001	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 2 · 24 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ciclopirox	CICLOPIROX	Acella Pharmaceuticals, LLC	a08137a9-331f-4615-9752-e2cb52b3d8fc	2026-07-10	Warnings, Adverse reactions	Name fallback generic name: CICLOPIROX
Ciclopirox	CICLOPIROX	Bryant Ranch Prepack	d7e22682-1485-47e5-b6ae-94534bd3d889	2026-06-22	Warnings, Adverse reactions	Name fallback generic name: CICLOPIROX
Ciclopirox	CICLOPIROX	Acella Pharmaceuticals, LLC	2c67dd09-ab1f-4ccf-97b5-421356f64f22	2026-06-19	Warnings, Adverse reactions	Name fallback generic name: CICLOPIROX
Ciclopirox	CICLOPIROX	Preferred Pharmaceuticals, Inc.	efcd78c0-2426-4fcc-a1c8-527e4e6f99d3	2026-03-27	Warnings, Adverse reactions	Name fallback generic name: CICLOPIROX
CICLOPIROX	CICLOPIROX	Bryant Ranch Prepack	f3e0ea78-42c0-4430-b299-fffee9e09c16	2026-03-18	Warnings, Adverse reactions	Name fallback generic name: CICLOPIROX
CICLOPIROX	CICLOPIROX	Encube Ethicals, Inc.	cb456f2e-6645-4cc4-8e71-299c47ccb6b7	2026-01-30	Warnings, Adverse reactions	Name fallback generic name: CICLOPIROX
ciclopirox	CICLOPIROX	Glenmark Pharmaceuticals Inc., USA	3c22416e-4293-4ba5-a983-137cbc6022db	2026-01-23	Warnings, Adverse reactions	Name fallback generic name: CICLOPIROX
CICLOPIROX	CICLOPIROX	Preferred Pharmaceuticals Inc.	eb7b7163-2ee7-447a-b585-7a240070f84b	2026-01-19	Warnings, Adverse reactions	Name fallback generic name: CICLOPIROX
Ciclopirox	CICLOPIROX	A-S Medication Solutions	b281493f-ce8c-42f8-95c7-2eb1c9712157	2025-11-12	Warnings, Adverse reactions	Name fallback generic name: CICLOPIROX
CICLOPIROX	CICLOPIROX	Bryant Ranch Prepack	1548af93-0dc1-4606-865f-6201b2bb7de1	2025-10-22	Warnings, Adverse reactions	Name fallback generic name: CICLOPIROX
Ciclopirox	CICLOPIROX	Chartwell RX, LLC	8ce98020-5615-4332-bf57-72777e2ce038	2025-10-21	Warnings, Adverse reactions	Name fallback generic name: CICLOPIROX
CICLOPIROX	CICLOPIROX	Encube Ethicals, Inc.	79084b47-7481-4926-9837-e08f633b1ddf	2025-10-13	Warnings, Adverse reactions	Name fallback generic name: CICLOPIROX
CICLOPIROX	CICLOPIROX	Bryant Ranch Prepack	51993bbb-f145-4662-8138-4db774cc0513	2025-09-16	Warnings, Adverse reactions	Name fallback generic name: CICLOPIROX
ciclopirox	CICLOPIROX	Bryant Ranch Prepack	810bfb01-a69d-4b00-ac2d-b92e7ddad9f9	2025-08-08	Warnings, Adverse reactions	Name fallback generic name: CICLOPIROX
Ciclopirox	CICLOPIROX	Sun Pharmaceutical Industries, Inc.	b44b190b-8e2a-4937-a6c5-92f37911e7f8	2025-07-07	Warnings, Adverse reactions	Name fallback generic name: CICLOPIROX
CICLOPIROX	CICLOPIROX	Padagis US LLC	b6a02568-867b-4c7b-890f-5d28bf0b363d	2024-11-01	Warnings, Adverse reactions	Name fallback generic name: CICLOPIROX
Ciclopirox	CICLOPIROX	Bryant Ranch Prepack	aaa27021-68a6-486c-9095-56de1140ca2d	2024-03-21	Warnings, Adverse reactions	Name fallback generic name: CICLOPIROX
Ciclopirox	CICLOPIROX	Actavis Pharma, Inc.	eef13684-751f-47e1-b75e-3401a0e6e20f	2023-10-30	Warnings, Adverse reactions	Name fallback generic name: CICLOPIROX
Ciclopirox	CICLOPIROX	Bryant Ranch Prepack	9c7d1fd9-71dd-4bbb-aed2-7db5cffa8b5a	2023-07-17	Warnings, Adverse reactions	Name fallback generic name: CICLOPIROX
CICLOPIROX	CICLOPIROX	Bryant Ranch Prepack	9861c88d-528f-4e30-8c1e-56ac3afec76c	2023-07-17	Warnings, Adverse reactions	Name fallback generic name: CICLOPIROX

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0168-0522	Ciclopirox	ciclopirox	E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
99207-010	Loprox	ciclopirox	Bausch Health US, LLC	NDA	Current
99207-010	Loprox	ciclopirox	Valeant Pharmaceuticals North America LLC	NDA	Current
99207-010	Loprox	ciclopirox	Bausch Health US, LLC	NDA	Current
99207-010	Loprox	ciclopirox	Bausch Health US, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
36243	SUPPL	2013-05-14
4504	SUPPL	2013-05-10
4503	SUPPL	2012-12-11
36242	SUPPL	2012-12-07
36241	SUPPL	2006-06-14
26938	SUPPL	2006-06-14
4502	SUPPL	2004-02-27
41994	ORIG	2003-07-08
26937	ORIG	2003-03-10
36240	ORIG	2003-02-28