Application 209355

Type: NDA
Sponsor: BAUSCH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BRYHALI	HALOBETASOL PROPIONATE	LOTION;TOPICAL	0.01%	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N209355-001	BRYHALI	HALOBETASOL PROPIONATE	0.01%	LOTION / TOPICAL		RLD, RS	2018-11-06

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N209355-001	10478502	2031-11-02	U-2625	Drug product	2019-11-22
N209355-001	11839656	2031-11-02	U-2625		2024-01-05
N209355-001	11957753	2031-11-02		Drug product	2024-05-10
N209355-001	11986527	2031-11-02	U-2625		2024-06-13
N209355-001	12076403	2031-11-02		Drug product	2024-09-24
N209355-001	8809307	2031-11-02		Drug product	2019-05-13

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N209355-001	BRYHALI	0.01%	LOTION / TOPICAL	RLD, RS	2018-11-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209355-001	BRYHALI	0.01%	LOTION / TOPICAL	RLD, RS	2018-11-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209355-001	BRYHALI	0.01%	LOTION / TOPICAL	RLD, RS	2018-11-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209355-001	BRYHALI	0.01%	LOTION / TOPICAL	RLD, RS	2018-11-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209355-001	BRYHALI	0.01%	LOTION / TOPICAL	RLD, RS	2018-11-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209355-001	BRYHALI	0.01%	LOTION / TOPICAL	RLD, RS	2018-11-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209355-001	BRYHALI	0.01%	LOTION / TOPICAL	RLD, RS	2018-11-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209355-001	BRYHALI	0.01%	LOTION / TOPICAL	RLD, RS	2018-11-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209355-001	BRYHALI	0.01%	LOTION / TOPICAL	RLD, RS	2018-11-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209355-001	BRYHALI	0.01%	LOTION / TOPICAL	RLD, RS	2018-11-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209355-001	BRYHALI	0.01%	LOTION / TOPICAL	RLD, RS	2018-11-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209355-001	BRYHALI	0.01%	LOTION / TOPICAL	RLD, RS	2018-11-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209355-001	BRYHALI	0.01%	LOTION / TOPICAL	RLD, RS	2018-11-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209355-001	BRYHALI	0.01%	LOTION / TOPICAL	RLD, RS	2018-11-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209355-001	BRYHALI	0.01%	LOTION / TOPICAL	RLD, RS	2018-11-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209355-001	BRYHALI	0.01%	LOTION / TOPICAL	RLD, RS	2018-11-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209355-001	BRYHALI	0.01%	LOTION / TOPICAL	RLD, RS	2018-11-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209355-001	BRYHALI	0.01%	LOTION / TOPICAL	RLD, RS	2018-11-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209355-001	BRYHALI	0.01%	LOTION / TOPICAL	RLD, RS	2018-11-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209355-001	BRYHALI	0.01%	LOTION / TOPICAL	RLD, RS	2018-11-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209355-001	BRYHALI	0.01%	LOTION / TOPICAL	RLD, RS	2018-11-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209355-001	BRYHALI	0.01%	LOTION / TOPICAL	RLD, RS	2018-11-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209355-001	BRYHALI	0.01%	LOTION / TOPICAL	RLD, RS	2018-11-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209355-001	BRYHALI	0.01%	LOTION / TOPICAL	RLD, RS	2018-11-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209355-001	BRYHALI	0.01%	LOTION / TOPICAL	RLD, RS	2018-11-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N209355-001	BRYHALI	0.01%	LOTION / TOPICAL	RLD, RS	2018-11-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N209355-001	BRYHALI	0.01%	LOTION / TOPICAL	RLD, RS	2018-11-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N209355-001	BRYHALI	0.01%	LOTION / TOPICAL	RLD, RS	2018-11-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N209355-001	BRYHALI	0.01%	LOTION / TOPICAL	RLD, RS	2018-11-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N209355-001	BRYHALI	0.01%	LOTION / TOPICAL	RLD, RS	2018-11-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N209355-001	BRYHALI	0.01%	LOTION / TOPICAL	RLD, RS	2018-11-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N209355-001	BRYHALI	0.01%	LOTION / TOPICAL	RLD, RS	2018-11-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N209355-001	BRYHALI	0.01%	LOTION / TOPICAL	RLD, RS	2018-11-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N209355-001	BRYHALI	0.01%	LOTION / TOPICAL	RLD, RS	2018-11-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N209355-001	BRYHALI	0.01%	LOTION / TOPICAL	RLD, RS	2018-11-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N209355-001	BRYHALI	0.01%	LOTION / TOPICAL	RLD, RS	2018-11-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N209355-001	BRYHALI	0.01%	LOTION / TOPICAL	RLD, RS	2018-11-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N209355-001	BRYHALI	0.01%	LOTION / TOPICAL	RLD, RS	2018-11-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N209355-001	BRYHALI	0.01%	LOTION / TOPICAL	RLD, RS	2018-11-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N209355-001	BRYHALI	0.01%	LOTION / TOPICAL	RLD, RS	2018-11-06	`e64feba35796…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 146 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N209355-001	10478502	2031-11-02	U-2625	Drug product	2019-11-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209355-001	11839656	2031-11-02	U-2625		2024-01-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209355-001	11957753	2031-11-02		Drug product	2024-05-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209355-001	11986527	2031-11-02	U-2625		2024-06-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209355-001	12076403	2031-11-02		Drug product	2024-09-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209355-001	8809307	2031-11-02		Drug product	2019-05-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209355-001	10478502	2031-11-02	U-2625	Drug product	2019-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209355-001	11839656	2031-11-02	U-2625		2024-01-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209355-001	11957753	2031-11-02		Drug product	2024-05-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209355-001	11986527	2031-11-02	U-2625		2024-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209355-001	12076403	2031-11-02		Drug product	2024-09-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209355-001	8809307	2031-11-02		Drug product	2019-05-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209355-001	10478502	2031-11-02	U-2625	Drug product	2019-11-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209355-001	11839656	2031-11-02	U-2625		2024-01-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209355-001	11957753	2031-11-02		Drug product	2024-05-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209355-001	11986527	2031-11-02	U-2625		2024-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209355-001	12076403	2031-11-02		Drug product	2024-09-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209355-001	8809307	2031-11-02		Drug product	2019-05-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209355-001	10478502	2031-11-02	U-2625	Drug product	2019-11-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209355-001	11839656	2031-11-02	U-2625		2024-01-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209355-001	11957753	2031-11-02		Drug product	2024-05-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209355-001	11986527	2031-11-02	U-2625		2024-06-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209355-001	12076403	2031-11-02		Drug product	2024-09-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209355-001	8809307	2031-11-02		Drug product	2019-05-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209355-001	10478502	2031-11-02	U-2625	Drug product	2019-11-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209355-001	11839656	2031-11-02	U-2625		2024-01-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209355-001	11957753	2031-11-02		Drug product	2024-05-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209355-001	11986527	2031-11-02	U-2625		2024-06-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209355-001	12076403	2031-11-02		Drug product	2024-09-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209355-001	8809307	2031-11-02		Drug product	2019-05-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209355-001	10478502	2031-11-02	U-2625	Drug product	2019-11-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209355-001	11839656	2031-11-02	U-2625		2024-01-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209355-001	11957753	2031-11-02		Drug product	2024-05-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209355-001	11986527	2031-11-02	U-2625		2024-06-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209355-001	12076403	2031-11-02		Drug product	2024-09-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209355-001	8809307	2031-11-02		Drug product	2019-05-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209355-001	10478502	2031-11-02	U-2625	Drug product	2019-11-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209355-001	11839656	2031-11-02	U-2625		2024-01-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209355-001	11957753	2031-11-02		Drug product	2024-05-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209355-001	11986527	2031-11-02	U-2625		2024-06-13	`03ed91905a0d…`

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	N209355-001	NP	2021-11-06	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N209355-001	NP	2021-11-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209355-001	NP	2021-11-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209355-001	NP	2021-11-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209355-001	NP	2021-11-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209355-001	NP	2021-11-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N209355-001	NP	2021-11-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N209355-001	NP	2021-11-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N209355-001	NP	2021-11-06	`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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bryhali	HALOBETASOL PROPIONATE	Bausch Health US, LLC	d4bbb66a-3f9d-4091-b1b0-1cbc908432d3	2020-06-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 209355 application number: NDA209355 ndc (product): 0187-0002

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0187-0002	Bryhali	halobetasol propionate	Bausch Health US, LLC	NDA	Current
0187-0002	Bryhali	halobetasol propionate	Bausch Health Americas Inc.	NDA	Current
0187-0002	Bryhali	halobetasol propionate	Valeant Pharmaceuticals North America LLC	NDA	Current
0187-0002	Bryhali	halobetasol propionate	Bausch Health US, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
57038	ORIG	2018-12-26
55935	ORIG	2018-11-15
56361	ORIG	2018-11-08