Application 214510

Type: NDA
Sponsor: SOL-GEL TECHNOLOGIES

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	EPSOLAY	BENZOYL PEROXIDE	CREAM;TOPICAL	5%	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
N214510-001	EPSOLAY	BENZOYL PEROXIDE	5%	CREAM / TOPICAL		RLD, RS	2022-04-22

Orange Book patents#

Current patent rows page 1 of 1 · 14 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N214510-001	12156946	2028-02-03		Drug product	2024-12-18
N214510-001	12350382	2028-02-03		Drug product	2025-07-09
N214510-001	9868103	2028-08-08	U-3356	Drug product	2022-04-29
N214510-001	9687465	2032-11-27	U-3356	Drug product	2022-04-29
N214510-001	10933046	2040-02-19	U-3357	Drug product	2022-04-29
N214510-001	10945987	2040-02-19	U-3356		2022-04-29
N214510-001	11541026	2040-02-19	U-3356		2023-02-01
N214510-001	11865100	2040-02-19	U-3357		2024-02-05
N214510-001	11877997	2040-02-19	U-3356		2024-02-16
N214510-001	11986456	2040-02-19	U-3947		2024-06-17
N214510-001	11426378	2040-08-18	U-3356		2022-10-07
N214510-001	11628155	2040-12-27	U-3356		2023-05-17
N214510-001	12295935	2040-12-27	U-3356		2025-05-23
N214510-001	12257348	2041-05-23	U-3947	Drug product	2025-04-10

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.

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	N214510-001	EPSOLAY	5%	CREAM / TOPICAL	RLD, RS	2022-04-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214510-001	EPSOLAY	5%	CREAM / TOPICAL	RLD, RS	2022-04-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214510-001	EPSOLAY	5%	CREAM / TOPICAL	RLD, RS	2022-04-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214510-001	EPSOLAY	5%	CREAM / TOPICAL	RLD, RS	2022-04-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214510-001	EPSOLAY	5%	CREAM / TOPICAL	RLD, RS	2022-04-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214510-001	EPSOLAY	5%	CREAM / TOPICAL	RLD, RS	2022-04-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214510-001	EPSOLAY	5%	CREAM / TOPICAL	RLD, RS	2022-04-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214510-001	EPSOLAY	5%	CREAM / TOPICAL	RLD, RS	2022-04-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214510-001	EPSOLAY	5%	CREAM / TOPICAL	RLD, RS	2022-04-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214510-001	EPSOLAY	5%	CREAM / TOPICAL	RLD, RS	2022-04-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214510-001	EPSOLAY	5%	CREAM / TOPICAL	RLD, RS	2022-04-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214510-001	EPSOLAY	5%	CREAM / TOPICAL	RLD, RS	2022-04-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214510-001	EPSOLAY	5%	CREAM / TOPICAL	RLD, RS	2022-04-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214510-001	EPSOLAY	5%	CREAM / TOPICAL	RLD, RS	2022-04-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214510-001	EPSOLAY	5%	CREAM / TOPICAL	RLD, RS	2022-04-22	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214510-001	EPSOLAY	5%	CREAM / TOPICAL	RLD, RS	2022-04-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N214510-001	EPSOLAY	5%	CREAM / TOPICAL	RLD, RS	2022-04-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N214510-001	EPSOLAY	5%	CREAM / TOPICAL	RLD, RS	2022-04-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N214510-001	EPSOLAY	5%	CREAM / TOPICAL	RLD, RS	2022-04-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N214510-001	EPSOLAY	5%	CREAM / TOPICAL	RLD, RS	2022-04-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N214510-001	EPSOLAY	5%	CREAM / TOPICAL	RLD, RS	2022-04-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N214510-001	EPSOLAY	5%	CREAM / TOPICAL	RLD, RS	2022-04-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N214510-001	EPSOLAY	5%	CREAM / TOPICAL	RLD, RS	2022-04-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N214510-001	EPSOLAY	5%	CREAM / TOPICAL	RLD, RS	2022-04-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N214510-001	EPSOLAY	5%	CREAM / TOPICAL	RLD, RS	2022-04-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N214510-001	EPSOLAY	5%	CREAM / TOPICAL	RLD, RS	2022-04-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N214510-001	EPSOLAY	5%	CREAM / TOPICAL	RLD, RS	2022-04-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N214510-001	EPSOLAY	5%	CREAM / TOPICAL	RLD, RS	2022-04-22	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214510-001	EPSOLAY	5%	CREAM / TOPICAL	RLD, RS	2022-04-22	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 7 · 252 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	N214510-001	12156946	2028-02-03		Drug product	2024-12-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214510-001	12350382	2028-02-03		Drug product	2025-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214510-001	9868103	2028-08-08	U-3356	Drug product	2022-04-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214510-001	9687465	2032-11-27	U-3356	Drug product	2022-04-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214510-001	10933046	2040-02-19	U-3357	Drug product	2022-04-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214510-001	10945987	2040-02-19	U-3356		2022-04-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214510-001	11541026	2040-02-19	U-3356		2023-02-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214510-001	11865100	2040-02-19	U-3357		2024-02-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214510-001	11877997	2040-02-19	U-3356		2024-02-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214510-001	11986456	2040-02-19	U-3947		2024-06-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214510-001	11426378	2040-08-18	U-3356		2022-10-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214510-001	11628155	2040-12-27	U-3356		2023-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214510-001	12295935	2040-12-27	U-3356		2025-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214510-001	12257348	2041-05-23	U-3947	Drug product	2025-04-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214510-001	12156946	2028-02-03		Drug product	2024-12-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214510-001	12350382	2028-02-03		Drug product	2025-07-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214510-001	9868103	2028-08-08	U-3356	Drug product	2022-04-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214510-001	9687465	2032-11-27	U-3356	Drug product	2022-04-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214510-001	10933046	2040-02-19	U-3357	Drug product	2022-04-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214510-001	10945987	2040-02-19	U-3356		2022-04-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214510-001	11541026	2040-02-19	U-3356		2023-02-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214510-001	11865100	2040-02-19	U-3357		2024-02-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214510-001	11877997	2040-02-19	U-3356		2024-02-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214510-001	11986456	2040-02-19	U-3947		2024-06-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214510-001	11426378	2040-08-18	U-3356		2022-10-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214510-001	11628155	2040-12-27	U-3356		2023-05-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214510-001	12295935	2040-12-27	U-3356		2025-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214510-001	12257348	2041-05-23	U-3947	Drug product	2025-04-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214510-001	12156946	2028-02-03		Drug product	2024-12-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214510-001	12350382	2028-02-03		Drug product	2025-07-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214510-001	9868103	2028-08-08	U-3356	Drug product	2022-04-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214510-001	9687465	2032-11-27	U-3356	Drug product	2022-04-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214510-001	10933046	2040-02-19	U-3357	Drug product	2022-04-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214510-001	10945987	2040-02-19	U-3356		2022-04-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214510-001	11541026	2040-02-19	U-3356		2023-02-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214510-001	11865100	2040-02-19	U-3357		2024-02-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214510-001	11877997	2040-02-19	U-3356		2024-02-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214510-001	11986456	2040-02-19	U-3947		2024-06-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214510-001	11426378	2040-08-18	U-3356		2022-10-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214510-001	11628155	2040-12-27	U-3356		2023-05-17	`6a471c1ec25d…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214510-001	NP	2025-04-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214510-001	NP	2025-04-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214510-001	NP	2025-04-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214510-001	NP	2025-04-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214510-001	NP	2025-04-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214510-001	NP	2025-04-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214510-001	NP	2025-04-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214510-001	NP	2025-04-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214510-001	NP	2025-04-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214510-001	NP	2025-04-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214510-001	NP	2025-04-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214510-001	NP	2025-04-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214510-001	NP	2025-04-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214510-001	NP	2025-04-22	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214510-001	NP	2025-04-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N214510-001	NP	2025-04-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N214510-001	NP	2025-04-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N214510-001	NP	2025-04-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N214510-001	NP	2025-04-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N214510-001	NP	2025-04-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N214510-001	NP	2025-04-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N214510-001	NP	2025-04-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N214510-001	NP	2025-04-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N214510-001	NP	2025-04-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N214510-001	NP	2025-04-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N214510-001	NP	2025-04-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N214510-001	NP	2025-04-22	`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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Epsolay	BENZOYL PEROXIDE	Mayne Pharma Commercial LLC	641981e6-460b-44dd-8146-306c47e5367c	2025-08-11	Warnings, Adverse reactions	Exact identifier application applno (NDA): 214510 application number: NDA214510

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0299-5890	EPSOLAY	Benzoyl Peroxide	Galderma Laboratories, L.P.	NDA	Current
0299-5890	EPSOLAY	Benzoyl Peroxide	Galderma Laboratories, L.P.	NDA	Current
79167-005	EPSOLAY	BENZOYL PEROXIDE	Sol-Gel Technologies Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
73455	ORIG	2023-02-13
70815	ORIG	2022-04-26