Application 210566

Type: NDA
Sponsor: MAYNE PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LEXETTE	HALOBETASOL PROPIONATE	AEROSOL, FOAM;TOPICAL	0.05%	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
N210566-001	LEXETTE	HALOBETASOL PROPIONATE	0.05%	AEROSOL, FOAM / TOPICAL		RLD	2018-05-24

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N210566-001	10857159	2036-11-30		Drug product	2020-12-11
N210566-001	11020407	2036-11-30	U-3143	Drug product	2021-06-29
N210566-001	10857159*PED	2037-05-30		Pediatric extension

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	N210566-001	LEXETTE	0.05%	AEROSOL, FOAM / TOPICAL	AB	RLD, RS	2018-05-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210566-001	LEXETTE	0.05%	AEROSOL, FOAM / TOPICAL	AB	RLD, RS	2018-05-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210566-001	LEXETTE	0.05%	AEROSOL, FOAM / TOPICAL	AB	RLD, RS	2018-05-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210566-001	LEXETTE	0.05%	AEROSOL, FOAM / TOPICAL	AB	RLD, RS	2018-05-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210566-001	LEXETTE	0.05%	AEROSOL, FOAM / TOPICAL	AB	RLD, RS	2018-05-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210566-001	LEXETTE	0.05%	AEROSOL, FOAM / TOPICAL	AB	RLD, RS	2018-05-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210566-001	LEXETTE	0.05%	AEROSOL, FOAM / TOPICAL	AB	RLD, RS	2018-05-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210566-001	LEXETTE	0.05%	AEROSOL, FOAM / TOPICAL	AB	RLD, RS	2018-05-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210566-001	LEXETTE	0.05%	AEROSOL, FOAM / TOPICAL	AB	RLD, RS	2018-05-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N210566-001	LEXETTE	0.05%	AEROSOL, FOAM / TOPICAL	AB	RLD, RS	2018-05-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210566-001	LEXETTE	0.05%	AEROSOL, FOAM / TOPICAL	AB	RLD, RS	2018-05-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210566-001	LEXETTE	0.05%	AEROSOL, FOAM / TOPICAL	AB	RLD, RS	2018-05-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210566-001	LEXETTE	0.05%	AEROSOL, FOAM / TOPICAL	AB	RLD, RS	2018-05-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N210566-001	LEXETTE	0.05%	AEROSOL, FOAM / TOPICAL	AB	RLD, RS	2018-05-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210566-001	LEXETTE	0.05%	AEROSOL, FOAM / TOPICAL		RLD, RS	2018-05-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N210566-001	LEXETTE	0.05%	AEROSOL, FOAM / TOPICAL		RLD, RS	2018-05-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N210566-001	LEXETTE	0.05%	AEROSOL, FOAM / TOPICAL		RLD, RS	2018-05-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N210566-001	LEXETTE	0.05%	AEROSOL, FOAM / TOPICAL		RLD, RS	2018-05-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N210566-001	LEXETTE	0.05%	AEROSOL, FOAM / TOPICAL		RLD, RS	2018-05-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N210566-001	LEXETTE	0.05%	AEROSOL, FOAM / TOPICAL		RLD, RS	2018-05-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210566-001	LEXETTE	0.05%	AEROSOL, FOAM / TOPICAL		RLD, RS	2018-05-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N210566-001	LEXETTE	0.05%	AEROSOL, FOAM / TOPICAL		RLD, RS	2018-05-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N210566-001	LEXETTE	0.05%	AEROSOL, FOAM / TOPICAL		RLD, RS	2018-05-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N210566-001	LEXETTE	0.05%	AEROSOL, FOAM / TOPICAL		RLD, RS	2018-05-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N210566-001	LEXETTE	0.05%	AEROSOL, FOAM / TOPICAL		RLD, RS	2018-05-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N210566-001	HALOBETASOL PROPIONATE	0.05%	AEROSOL, FOAM / TOPICAL		RLD, RS	2018-05-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N210566-001	HALOBETASOL PROPIONATE	0.05%	AEROSOL, FOAM / TOPICAL		RLD, RS	2018-05-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N210566-001	LEXETTE	0.05%	AEROSOL, FOAM / TOPICAL	AB	RLD, RS	2018-05-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N210566-001	LEXETTE	0.05%	AEROSOL, FOAM / TOPICAL	AB	RLD, RS	2018-05-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N210566-001	LEXETTE	0.05%	AEROSOL, FOAM / TOPICAL	AB	RLD, RS	2018-05-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N210566-001	LEXETTE	0.05%	AEROSOL, FOAM / TOPICAL	AB	RLD, RS	2018-05-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N210566-001	LEXETTE	0.05%	AEROSOL, FOAM / TOPICAL	AB	RLD, RS	2018-05-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N210566-001	LEXETTE	0.05%	AEROSOL, FOAM / TOPICAL		RLD, RS	2018-05-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N210566-001	LEXETTE	0.05%	AEROSOL, FOAM / TOPICAL		RLD, RS	2018-05-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N210566-001	LEXETTE	0.05%	AEROSOL, FOAM / TOPICAL		RLD, RS	2018-05-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N210566-001	LEXETTE	0.05%	AEROSOL, FOAM / TOPICAL		RLD, RS	2018-05-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N210566-001	LEXETTE	0.05%	AEROSOL, FOAM / TOPICAL		RLD, RS	2018-05-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N210566-001	LEXETTE	0.05%	AEROSOL, FOAM / TOPICAL		RLD, RS	2018-05-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N210566-001	LEXETTE	0.05%	AEROSOL, FOAM / TOPICAL		RLD, RS	2018-05-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N210566-001	LEXETTE	0.05%	AEROSOL, FOAM / TOPICAL		RLD, RS	2018-05-24	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N210566-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210566-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210566-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210566-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210566-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210566-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210566-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210566-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210566-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N210566-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210566-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210566-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210566-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N210566-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N210566-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N210566-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N210566-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N210566-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N210566-001	AB	1	`9b2671bbb829…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 101 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	N210566-001	10857159	2036-11-30		Drug product	2020-12-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210566-001	11020407	2036-11-30	U-3143	Drug product	2021-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210566-001	10857159*PED	2037-05-30		Pediatric extension		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210566-001	10857159	2036-11-30		Drug product	2020-12-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210566-001	11020407	2036-11-30	U-3143	Drug product	2021-06-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210566-001	10857159*PED	2037-05-30		Pediatric extension		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210566-001	10857159	2036-11-30		Drug product	2020-12-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210566-001	11020407	2036-11-30	U-3143	Drug product	2021-06-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210566-001	10857159*PED	2037-05-30		Pediatric extension		`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210566-001	10857159	2036-11-30		Drug product	2020-12-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210566-001	11020407	2036-11-30	U-3143	Drug product	2021-06-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210566-001	10857159*PED	2037-05-30		Pediatric extension		`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210566-001	10857159	2036-11-30		Drug product	2020-12-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210566-001	11020407	2036-11-30	U-3143	Drug product	2021-06-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210566-001	10857159*PED	2037-05-30		Pediatric extension		`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210566-001	10857159	2036-11-30		Drug product	2020-12-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210566-001	11020407	2036-11-30	U-3143	Drug product	2021-06-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210566-001	10857159*PED	2037-05-30		Pediatric extension		`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210566-001	10857159	2036-11-30		Drug product	2020-12-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210566-001	11020407	2036-11-30	U-3143	Drug product	2021-06-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210566-001	10857159*PED	2037-05-30		Pediatric extension		`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210566-001	10857159	2036-11-30		Drug product	2020-12-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210566-001	11020407	2036-11-30	U-3143	Drug product	2021-06-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210566-001	10857159*PED	2037-05-30		Pediatric extension		`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210566-001	10857159	2036-11-30		Drug product	2020-12-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210566-001	11020407	2036-11-30	U-3143	Drug product	2021-06-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210566-001	10857159*PED	2037-05-30		Pediatric extension		`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N210566-001	10857159	2036-11-30		Drug product	2020-12-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N210566-001	11020407	2036-11-30	U-3143	Drug product	2021-06-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N210566-001	10857159*PED	2037-05-30		Pediatric extension		`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210566-001	10857159	2036-11-30		Drug product	2020-12-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210566-001	11020407	2036-11-30	U-3143	Drug product	2021-06-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210566-001	10857159*PED	2037-05-30		Pediatric extension		`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210566-001	10857159	2036-11-30		Drug product	2020-12-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210566-001	11020407	2036-11-30	U-3143	Drug product	2021-06-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210566-001	10857159*PED	2037-05-30		Pediatric extension		`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210566-001	10857159	2036-11-30		Drug product	2020-12-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210566-001	11020407	2036-11-30	U-3143	Drug product	2021-06-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210566-001	10857159*PED	2037-05-30		Pediatric extension		`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N210566-001	10857159	2036-11-30		Drug product	2020-12-11	`8072bd15b7f6…`

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	N210566-001	NPP	2024-08-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210566-001	NPP	2024-08-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210566-001	NPP	2024-08-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210566-001	NPP	2024-08-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N210566-001	NPP	2024-08-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210566-001	NPP	2024-08-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210566-001	NPP	2024-08-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210566-001	NPP	2024-08-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N210566-001	NPP	2024-08-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210566-001	NPP	2024-08-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N210566-001	NPP	2024-08-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N210566-001	NPP	2024-08-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N210566-001	NDF	2021-05-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N210566-001	NPP	2024-08-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N210566-001	NDF	2021-05-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210566-001	NDF	2021-05-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N210566-001	NDF	2021-05-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N210566-001	NDF	2021-05-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N210566-001	NDF	2021-05-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N210566-001	NDF	2021-05-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N210566-001	NDF	2021-05-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N210566-001	NDF	2021-05-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N210566-001	NPP	2024-08-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N210566-001	NPP	2024-08-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N210566-001	NPP	2024-08-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N210566-001	NPP	2024-08-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N210566-001	NPP	2024-08-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N210566-001	NPP	2024-08-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N210566-001	NPP	2024-08-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N210566-001	NPP	2024-08-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N210566-001	NPP	2024-08-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N210566-001	NPP	2024-08-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N210566-001	NPP	2024-08-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N210566-001	NPP	2024-08-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N210566-001	NPP	2024-08-18	`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 · 17 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Halobetasol Propionate	HALOBETASOL PROPIONATE	Coral Way Pharma, LLC	4cb1f7b3-c412-6fc7-e063-6394a90a63c9	2026-06-29	Warnings, Adverse reactions	Name fallback generic name: HALOBETASOL PROPIONATE
Halobetasol Propionate	HALOBETASOL PROPIONATE	Encube Ethicals, Inc.	d4f03a79-3d5e-4a39-8ab0-8ebd3d804e39	2026-06-29	Adverse reactions	Name fallback generic name: HALOBETASOL PROPIONATE
Halobetasol Propionate	HALOBETASOL PROPIONATE	Bryant Ranch Prepack	e408184b-0545-4728-9f95-90d8cdec544a	2026-04-23	Adverse reactions	Name fallback generic name: HALOBETASOL PROPIONATE
LEXETTE	HALOBETASOL PROPIONATE	Mayne Pharma	8aa1f819-c81f-4af1-aaa7-353df3203ff6	2025-05-31	Warnings, Adverse reactions	Name fallback brand name: LEXETTE generic name: HALOBETASOL PROPIONATE
ULTRAVATE	HALOBETASOL PROPIONATE	Lacer Pharma, LLC	74e899db-1c1f-48b2-9913-5d32a14906ae	2025-04-06	Warnings, Adverse reactions	Name fallback generic name: HALOBETASOL PROPIONATE
Halobetasol Propionate	HALOBETASOL PROPIONATE	Bryant Ranch Prepack	83725d7b-0788-4903-a75a-8e318ee7b568	2024-10-24	Adverse reactions	Name fallback generic name: HALOBETASOL PROPIONATE
Halobetasol Propionate	HALOBETASOL PROPIONATE	Bryant Ranch Prepack	e78c7fc9-34ba-4162-a98e-78931dc31dab	2024-08-22	Adverse reactions	Name fallback generic name: HALOBETASOL PROPIONATE
Halobetasol Propionate	HALOBETASOL PROPIONATE	Bryant Ranch Prepack	14766ad1-d61d-4838-92e1-849a929f4dbd	2024-05-29	Adverse reactions	Name fallback generic name: HALOBETASOL PROPIONATE
Halobetasol Propionate	HALOBETASOL PROPIONATE	Cosette Pharmaceuticals, Inc.	f12ff257-dd77-4f9c-97c4-339784772d9f	2024-04-16	Adverse reactions	Name fallback generic name: HALOBETASOL PROPIONATE
Halobetasol Propionate	HALOBETASOL PROPIONATE	Bryant Ranch Prepack	be683823-9c07-498c-8357-71cbb3a3964c	2024-03-11	Adverse reactions	Name fallback generic name: HALOBETASOL PROPIONATE
Halobetasol propionate	HALOBETASOL PROPIONATE	Mayne Pharma	24c41e6d-a314-4984-b45f-e5aa1fffa9b6	2023-11-30	Warnings, Adverse reactions	Name fallback generic name: HALOBETASOL PROPIONATE
Halobetasol Propionate	HALOBETASOL PROPIONATE	Cosette Pharmaceuticals, Inc.	1f57aaae-8d5f-bfdf-08d6-495b84221311	2023-11-23	Adverse reactions	Name fallback generic name: HALOBETASOL PROPIONATE
Halobetasol Propionate	HALOBETASOL PROPIONATE	Bryant Ranch Prepack	c4e78fa5-6ced-4c90-89c6-31e5fc71b837	2023-08-15	Adverse reactions	Name fallback generic name: HALOBETASOL PROPIONATE
Halobetasol Propionate	HALOBETASOL PROPIONATE	QUAGEN PHARMACEUTICALS LLC	fd4ebec1-e5ba-46cc-9627-4645a7b3bf19	2023-02-02	Adverse reactions	Name fallback generic name: HALOBETASOL PROPIONATE
Halobetasol Propionate	HALOBETASOL PROPIONATE	Padagis Israel Pharmaceuticals Ltd	c420da92-a3e3-4760-8cad-e50cbacebfeb	2022-12-31	Adverse reactions	Name fallback generic name: HALOBETASOL PROPIONATE
Halobetasol Propionate	HALOBETASOL PROPIONATE	Padagis Israel Pharmaceuticals Ltd	df26430c-8182-4d03-a254-06d913de4c95	2022-12-01	Adverse reactions	Name fallback generic name: HALOBETASOL PROPIONATE
Bryhali	HALOBETASOL PROPIONATE	Bausch Health US, LLC	d4bbb66a-3f9d-4091-b1b0-1cbc908432d3	2020-06-01	Warnings, Adverse reactions	Name fallback generic name: HALOBETASOL PROPIONATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51862-604	LEXETTE	Halobetasol propionate	Mayne Pharma	NDA	Current
51862-604	LEXETTE	Halobetasol propionate	Mayne Pharma	NDA	Current
51862-604	LEXETTE	Halobetasol propionate	Mayne Pharma	NDA	Current
51862-604	LEXETTE	Halobetasol propionate	Mayne Pharma	NDA	Current
51862-606	Halobetasol propionate	Halobetasol propionate	Mayne Pharma	NDA	Current
51862-606	Halobetasol propionate	Halobetasol propionate	Mayne Pharma	NDA	Current
51862-606	Halobetasol propionate	Halobetasol propionate	Mayne Pharma	NDA	Current
51862-606	Halobetasol propionate	Halobetasol propionate	Mayne Pharma	NDA	Current
51862-606	Halobetasol propionate	Halobetasol propionate	Mayne Pharma	NDA	Current
55337-606	Halobetasol propionate	Halobetasol propionate	Pharmasol Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
71610	SUPPL	2022-07-20
71606	SUPPL	2022-07-20
68422	SUPPL	2021-08-19
68412	SUPPL	2021-08-19
62675	SUPPL	2020-04-24
62658	SUPPL	2020-04-24
58383	SUPPL	2019-04-24
56527	ORIG	2018-11-20
54355	ORIG	2018-05-29
54349	ORIG	2018-05-24