Application 204153

Type: NDA
Sponsor: MEDICIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LUZU	LULICONAZOLE	CREAM;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
N204153-001	LUZU	LULICONAZOLE	1%	CREAM / TOPICAL		RLD, RS	2013-11-14

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N204153-001	9012484	2033-09-06	U-540	Drug substance, Drug product	2015-04-22
N204153-001	9199977	2033-09-06		Drug substance, Drug product	2016-02-05
N204153-001	9453006	2033-09-06		Drug substance	2016-09-29
N204153-001	8980931	2034-04-28		Drug product	2015-03-23

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N204153-001	LUZU	1%	CREAM / TOPICAL	RLD, RS	2013-11-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204153-001	LUZU	1%	CREAM / TOPICAL	RLD, RS	2013-11-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204153-001	LUZU	1%	CREAM / TOPICAL	RLD, RS	2013-11-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204153-001	LUZU	1%	CREAM / TOPICAL	RLD, RS	2013-11-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204153-001	LUZU	1%	CREAM / TOPICAL	RLD, RS	2013-11-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204153-001	LUZU	1%	CREAM / TOPICAL	RLD, RS	2013-11-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204153-001	LUZU	1%	CREAM / TOPICAL	RLD, RS	2013-11-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204153-001	LUZU	1%	CREAM / TOPICAL	RLD, RS	2013-11-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204153-001	LUZU	1%	CREAM / TOPICAL	RLD, RS	2013-11-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204153-001	LUZU	1%	CREAM / TOPICAL	RLD, RS	2013-11-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204153-001	LUZU	1%	CREAM / TOPICAL	RLD, RS	2013-11-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204153-001	LUZU	1%	CREAM / TOPICAL	RLD, RS	2013-11-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204153-001	LUZU	1%	CREAM / TOPICAL	RLD, RS	2013-11-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N204153-001	LUZU	1%	CREAM / TOPICAL	RLD, RS	2013-11-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204153-001	LUZU	1%	CREAM / TOPICAL	RLD, RS	2013-11-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N204153-001	LUZU	1%	CREAM / TOPICAL	RLD, RS	2013-11-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N204153-001	LUZU	1%	CREAM / TOPICAL	RLD, RS	2013-11-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N204153-001	LUZU	1%	CREAM / TOPICAL	RLD, RS	2013-11-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N204153-001	LUZU	1%	CREAM / TOPICAL	RLD, RS	2013-11-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N204153-001	LUZU	1%	CREAM / TOPICAL	RLD, RS	2013-11-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N204153-001	LUZU	1%	CREAM / TOPICAL	RLD, RS	2013-11-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N204153-001	LUZU	1%	CREAM / TOPICAL	RLD, RS	2013-11-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N204153-001	LUZU	1%	CREAM / TOPICAL	RLD, RS	2013-11-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N204153-001	LUZU	1%	CREAM / TOPICAL	RLD, RS	2013-11-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N204153-001	LUZU	1%	CREAM / TOPICAL	RLD, RS	2013-11-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N204153-001	LUZU	1%	CREAM / TOPICAL	RLD, RS	2013-11-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N204153-001	LUZU	1%	CREAM / TOPICAL	RLD, RS	2013-11-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N204153-001	LUZU	1%	CREAM / TOPICAL	RLD, RS	2013-11-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N204153-001	LUZU	1%	CREAM / TOPICAL	RLD, RS	2013-11-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N204153-001	LUZU	1%	CREAM / TOPICAL	RLD, RS	2013-11-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N204153-001	LUZU	1%	CREAM / TOPICAL	RLD, RS	2013-11-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N204153-001	LUZU	1%	CREAM / TOPICAL	RLD, RS	2013-11-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N204153-001	LUZU	1%	CREAM / TOPICAL	RLD, RS	2013-11-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N204153-001	LUZU	1%	CREAM / TOPICAL	RLD, RS	2013-11-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N204153-001	LUZU	1%	CREAM / TOPICAL	RLD, RS	2013-11-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N204153-001	LUZU	1%	CREAM / TOPICAL	RLD, RS	2013-11-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N204153-001	LUZU	1%	CREAM / TOPICAL	RLD, RS	2013-11-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N204153-001	LUZU	1%	CREAM / TOPICAL	RLD, RS	2013-11-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N204153-001	LUZU	1%	CREAM / TOPICAL	RLD, RS	2013-11-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N204153-001	LUZU	1%	CREAM / TOPICAL	RLD, RS	2013-11-14	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 170 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N204153-001	9012484	2033-09-06	U-540	Drug substance, Drug product	2015-04-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204153-001	9199977	2033-09-06		Drug substance, Drug product	2016-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204153-001	9453006	2033-09-06		Drug substance	2016-09-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204153-001	8980931	2034-04-28		Drug product	2015-03-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204153-001	9012484	2033-09-06	U-540	Drug substance, Drug product	2015-04-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204153-001	9199977	2033-09-06		Drug substance, Drug product	2016-02-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204153-001	9453006	2033-09-06		Drug substance	2016-09-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204153-001	8980931	2034-04-28		Drug product	2015-03-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204153-001	9012484	2033-09-06	U-540	Drug substance, Drug product	2015-04-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204153-001	9199977	2033-09-06		Drug substance, Drug product	2016-02-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204153-001	9453006	2033-09-06		Drug substance	2016-09-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204153-001	8980931	2034-04-28		Drug product	2015-03-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204153-001	9012484	2033-09-06	U-540	Drug substance, Drug product	2015-04-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204153-001	9199977	2033-09-06		Drug substance, Drug product	2016-02-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204153-001	9453006	2033-09-06		Drug substance	2016-09-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204153-001	8980931	2034-04-28		Drug product	2015-03-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204153-001	9012484	2033-09-06	U-540	Drug substance, Drug product	2015-04-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204153-001	9199977	2033-09-06		Drug substance, Drug product	2016-02-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204153-001	9453006	2033-09-06		Drug substance	2016-09-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204153-001	8980931	2034-04-28		Drug product	2015-03-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204153-001	9012484	2033-09-06	U-540	Drug substance, Drug product	2015-04-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204153-001	9199977	2033-09-06		Drug substance, Drug product	2016-02-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204153-001	9453006	2033-09-06		Drug substance	2016-09-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204153-001	8980931	2034-04-28		Drug product	2015-03-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204153-001	9012484	2033-09-06	U-540	Drug substance, Drug product	2015-04-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204153-001	9199977	2033-09-06		Drug substance, Drug product	2016-02-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204153-001	9453006	2033-09-06		Drug substance	2016-09-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204153-001	8980931	2034-04-28		Drug product	2015-03-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204153-001	9012484	2033-09-06	U-540	Drug substance, Drug product	2015-04-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204153-001	9199977	2033-09-06		Drug substance, Drug product	2016-02-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204153-001	9453006	2033-09-06		Drug substance	2016-09-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204153-001	8980931	2034-04-28		Drug product	2015-03-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204153-001	9012484	2033-09-06	U-540	Drug substance, Drug product	2015-04-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204153-001	9199977	2033-09-06		Drug substance, Drug product	2016-02-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204153-001	9453006	2033-09-06		Drug substance	2016-09-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204153-001	8980931	2034-04-28		Drug product	2015-03-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204153-001	9012484	2033-09-06	U-540	Drug substance, Drug product	2015-04-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204153-001	9199977	2033-09-06		Drug substance, Drug product	2016-02-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204153-001	9453006	2033-09-06		Drug substance	2016-09-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204153-001	8980931	2034-04-28		Drug product	2015-03-23	`d06236e962d9…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N204153-001	NPP	2021-02-20	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N204153-001	NPP	2021-02-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N204153-001	NPP	2021-02-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N204153-001	NPP	2021-02-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N204153-001	NPP	2021-02-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N204153-001	NPP	2021-02-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N204153-001	NPP	2021-02-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N204153-001	NPP	2021-02-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N204153-001	NPP	2021-02-20	`ea99ee380514…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LULICONAZOLE	LULICONAZOLE	Oceanside Pharmaceuticals	7ccda3ba-9c98-468d-83c6-7f0cc7c88c33	2020-04-30	Adverse reactions	Exact identifier application applno (NDA): 204153 application number: NDA204153 ndc (product): 68682-850
Luzu	LULICONAZOLE	Bausch Health US, LLC	a7016010-ce43-4c09-8d21-aeb697ffed31	2020-04-01	Adverse reactions	Exact identifier application applno (NDA): 204153 application number: NDA204153 ndc (product): 99207-850

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
68682-850	LULICONAZOLE	LULICONAZOLE	Oceanside Pharmaceuticals	NDA	Current
68682-850	LULICONAZOLE	LULICONAZOLE	Oceanside Pharmaceuticals	NDA	Current
68682-850	LULICONAZOLE	LULICONAZOLE	Oceanside Pharmaceuticals	NDA	Current
68682-850	LULICONAZOLE	LULICONAZOLE	Oceanside Pharmaceuticals	NDA	Current
99207-850	Luzu	LULICONAZOLE	Bausch Health US, LLC	NDA	Current
99207-850	Luzu	LULICONAZOLE	Bausch Health US, LLC	NDA	Current
99207-850	Luzu	LULICONAZOLE	Bausch Health US, LLC	NDA	Current
99207-850	Luzu	LULICONAZOLE	Valeant Pharmaceuticals North America LLC	NDA	Current
99207-850	Luzu	LULICONAZOLE	Bausch Health US, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
52729	SUPPL	2018-02-26
52728	SUPPL	2018-02-26
52691	SUPPL	2018-02-23
52690	SUPPL	2018-02-23
47148	SUPPL	2017-02-09
47139	SUPPL	2017-02-09
43457	ORIG	2013-12-12
24460	ORIG	2013-12-12
32521	ORIG	2013-11-15
19531	ORIG	2013-11-15
63130	SUPPL	1900-01-01
63129	SUPPL	1900-01-01
63128	SUPPL	1900-01-01
63127	SUPPL	1900-01-01
63126	SUPPL	1900-01-01
63125	SUPPL	1900-01-01
63124	SUPPL	1900-01-01