Application 214902

Type: NDA
Sponsor: SOL-GEL TECHNOLOGIES LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TWYNEO	TRETINOIN;BENZOYL PEROXIDE	CREAM;TOPICAL	0.1%;3%	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
N214902-001	TWYNEO	BENZOYL PEROXIDE; TRETINOIN	3%;0.1%	CREAM / TOPICAL		RLD, RS	2021-07-26

Orange Book patents#

Current patent rows page 1 of 1 · 13 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N214902-001	12156946	2028-02-03		Drug product	2024-12-18
N214902-001	8617580	2028-02-03		Drug product	2021-11-24
N214902-001	9868103	2028-08-08	U-3194	Drug product	2021-08-23
N214902-001	10653899	2030-12-30	U-3194	Drug product	2021-11-24
N214902-001	11071878	2030-12-30		Drug product	2021-08-23
N214902-001	12070629	2030-12-30	U-3987	Drug product	2024-09-18
N214902-001	12053546	2032-06-29		Drug product	2024-08-26
N214902-001	10420743	2038-07-12	U-3194		2021-11-24
N214902-001	12357602	2038-07-12	U-3987	Drug product	2025-07-17
N214902-001	12295935	2040-12-27	U-3987		2025-05-23
N214902-001	12133919	2041-05-23	U-3987	Drug product	2024-12-03
N214902-001	12257348	2041-05-23	U-3987	Drug product	2025-04-10
N214902-001	12491163	2041-05-23	U-3987	Drug product	2025-12-16

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	N214902-001	TWYNEO	3%;0.1%	CREAM / TOPICAL	RLD, RS	2021-07-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214902-001	TWYNEO	3%;0.1%	CREAM / TOPICAL	RLD, RS	2021-07-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214902-001	TWYNEO	3%;0.1%	CREAM / TOPICAL	RLD, RS	2021-07-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214902-001	TWYNEO	3%;0.1%	CREAM / TOPICAL	RLD, RS	2021-07-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214902-001	TWYNEO	3%;0.1%	CREAM / TOPICAL	RLD, RS	2021-07-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214902-001	TWYNEO	3%;0.1%	CREAM / TOPICAL	RLD, RS	2021-07-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214902-001	TWYNEO	3%;0.1%	CREAM / TOPICAL	RLD, RS	2021-07-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214902-001	TWYNEO	3%;0.1%	CREAM / TOPICAL	RLD, RS	2021-07-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214902-001	TWYNEO	3%;0.1%	CREAM / TOPICAL	RLD, RS	2021-07-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214902-001	TWYNEO	3%;0.1%	CREAM / TOPICAL	RLD, RS	2021-07-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214902-001	TWYNEO	3%;0.1%	CREAM / TOPICAL	RLD, RS	2021-07-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214902-001	TWYNEO	3%;0.1%	CREAM / TOPICAL	RLD, RS	2021-07-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214902-001	TWYNEO	3%;0.1%	CREAM / TOPICAL	RLD, RS	2021-07-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214902-001	TWYNEO	3%;0.1%	CREAM / TOPICAL	RLD, RS	2021-07-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214902-001	TWYNEO	3%;0.1%	CREAM / TOPICAL	RLD, RS	2021-07-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N214902-001	TWYNEO	3%;0.1%	CREAM / TOPICAL	RLD, RS	2021-07-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N214902-001	TWYNEO	3%;0.1%	CREAM / TOPICAL	RLD	2021-07-26	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N214902-001	TWYNEO	3%;0.1%	CREAM / TOPICAL	RLD	2021-07-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N214902-001	TWYNEO	3%;0.1%	CREAM / TOPICAL	RLD, RS	2021-07-26	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214902-001	TWYNEO	3%;0.1%	CREAM / TOPICAL	RLD, RS	2021-07-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N214902-001	TWYNEO	3%;0.1%	CREAM / TOPICAL	RLD, RS	2021-07-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N214902-001	TWYNEO	3%;0.1%	CREAM / TOPICAL	RLD, RS	2021-07-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N214902-001	TWYNEO	3%;0.1%	CREAM / TOPICAL	RLD, RS	2021-07-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N214902-001	TWYNEO	3%;0.1%	CREAM / TOPICAL	RLD, RS	2021-07-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N214902-001	TWYNEO	3%;0.1%	CREAM / TOPICAL	RLD, RS	2021-07-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N214902-001	TWYNEO	3%;0.1%	CREAM / TOPICAL	RLD, RS	2021-07-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N214902-001	TWYNEO	3%;0.1%	CREAM / TOPICAL	RLD, RS	2021-07-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N214902-001	TWYNEO	3%;0.1%	CREAM / TOPICAL	RLD, RS	2021-07-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N214902-001	TWYNEO	3%;0.1%	CREAM / TOPICAL	RLD, RS	2021-07-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N214902-001	TWYNEO	3%;0.1%	CREAM / TOPICAL	RLD, RS	2021-07-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N214902-001	TWYNEO	3%;0.1%	CREAM / TOPICAL	RLD, RS	2021-07-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N214902-001	TWYNEO	3%;0.1%	CREAM / TOPICAL	RLD, RS	2021-07-26	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214902-001	TWYNEO	3%;0.1%	CREAM / TOPICAL	RLD, RS	2021-07-26	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 6 · 215 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	N214902-001	12156946	2028-02-03		Drug product	2024-12-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214902-001	8617580	2028-02-03		Drug product	2021-11-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214902-001	9868103	2028-08-08	U-3194	Drug product	2021-08-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214902-001	10653899	2030-12-30	U-3194	Drug product	2021-11-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214902-001	11071878	2030-12-30		Drug product	2021-08-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214902-001	12070629	2030-12-30	U-3987	Drug product	2024-09-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214902-001	12053546	2032-06-29		Drug product	2024-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214902-001	10420743	2038-07-12	U-3194		2021-11-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214902-001	12357602	2038-07-12	U-3987	Drug product	2025-07-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214902-001	12295935	2040-12-27	U-3987		2025-05-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214902-001	12133919	2041-05-23	U-3987	Drug product	2024-12-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214902-001	12257348	2041-05-23	U-3987	Drug product	2025-04-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214902-001	12491163	2041-05-23	U-3987	Drug product	2025-12-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214902-001	12156946	2028-02-03		Drug product	2024-12-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214902-001	8617580	2028-02-03		Drug product	2021-11-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214902-001	9868103	2028-08-08	U-3194	Drug product	2021-08-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214902-001	10653899	2030-12-30	U-3194	Drug product	2021-11-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214902-001	11071878	2030-12-30		Drug product	2021-08-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214902-001	12070629	2030-12-30	U-3987	Drug product	2024-09-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214902-001	12053546	2032-06-29		Drug product	2024-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214902-001	10420743	2038-07-12	U-3194		2021-11-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214902-001	12357602	2038-07-12	U-3987	Drug product	2025-07-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214902-001	12295935	2040-12-27	U-3987		2025-05-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214902-001	12133919	2041-05-23	U-3987	Drug product	2024-12-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214902-001	12257348	2041-05-23	U-3987	Drug product	2025-04-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214902-001	12156946	2028-02-03		Drug product	2024-12-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214902-001	8617580	2028-02-03		Drug product	2021-11-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214902-001	9868103	2028-08-08	U-3194	Drug product	2021-08-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214902-001	10653899	2030-12-30	U-3194	Drug product	2021-11-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214902-001	11071878	2030-12-30		Drug product	2021-08-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214902-001	12070629	2030-12-30	U-3987	Drug product	2024-09-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214902-001	12053546	2032-06-29		Drug product	2024-08-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214902-001	10420743	2038-07-12	U-3194		2021-11-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214902-001	12357602	2038-07-12	U-3987	Drug product	2025-07-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214902-001	12295935	2040-12-27	U-3987		2025-05-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214902-001	12133919	2041-05-23	U-3987	Drug product	2024-12-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214902-001	12257348	2041-05-23	U-3987	Drug product	2025-04-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214902-001	12156946	2028-02-03		Drug product	2024-12-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214902-001	8617580	2028-02-03		Drug product	2021-11-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214902-001	9868103	2028-08-08	U-3194	Drug product	2021-08-23	`fd3edfee7708…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214902-001	NC	2024-07-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214902-001	NC	2024-07-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214902-001	NC	2024-07-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214902-001	NC	2024-07-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214902-001	NC	2024-07-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214902-001	NC	2024-07-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214902-001	NC	2024-07-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214902-001	NC	2024-07-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214902-001	NC	2024-07-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214902-001	NC	2024-07-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N214902-001	NC	2024-07-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N214902-001	NC	2024-07-26	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N214902-001	NC	2024-07-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N214902-001	NC	2024-07-26	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214902-001	NC	2024-07-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N214902-001	NC	2024-07-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N214902-001	NC	2024-07-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N214902-001	NC	2024-07-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N214902-001	NC	2024-07-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N214902-001	NC	2024-07-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N214902-001	NC	2024-07-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N214902-001	NC	2024-07-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N214902-001	NC	2024-07-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N214902-001	NC	2024-07-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N214902-001	NC	2024-07-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N214902-001	NC	2024-07-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N214902-001	NC	2024-07-26	`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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Twyneo	BENZOYL PEROXIDE AND TRETINOIN	Mayne Pharma Commercial LLC	654ae869-5bc0-40b3-a423-dcc3270c05d8	2025-08-11	Warnings, Adverse reactions	Exact identifier application applno (NDA): 214902 application number: NDA214902
TWYNEO	TRETINOIN AND BENZOYL PEROXIDE	Galderma Laboratories, L.P.	27208dff-e376-4c18-b56e-0a260f685a39	2025-05-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 214902 application number: NDA214902 ndc (product): 0299-5945

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0299-5945	TWYNEO	tretinoin and benzoyl peroxide	Galderma Laboratories, L.P.	NDA	Current
79167-301	TWYNEO	tretinoin and benzoyl peroxide	Sol-Gel Technologies, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
71605	ORIG	2022-07-20
68198	ORIG	2021-07-27
68197	ORIG	2021-07-27