Application 209354

Type: NDA
Sponsor: BAUSCH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DUOBRII	HALOBETASOL PROPIONATE; TAZAROTENE	LOTION;TOPICAL	0.01%;0.045%	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
N209354-001	DUOBRII	HALOBETASOL PROPIONATE; TAZAROTENE	0.01%;0.045%	LOTION / TOPICAL	AB	RLD, RS	2019-04-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N209354-001	AB

Orange Book patents#

Current patent rows page 1 of 1 · 10 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N209354-001	10478502	2031-11-02	U-2625	Drug product	2019-11-22
N209354-001	11839656	2031-11-02	U-2625		2024-01-05
N209354-001	11957753	2031-11-02		Drug product	2024-05-10
N209354-001	11986527	2031-11-02	U-2625		2024-06-13
N209354-001	12076403	2031-11-02		Drug product	2024-09-24
N209354-001	8809307	2031-11-02		Drug product	2019-04-30
N209354-001	10251895	2036-06-06		Drug product	2019-04-26
N209354-001	10426787	2036-06-06	U-2625		2019-10-09
N209354-001	11648256	2036-06-06	U-2625	Drug product	2023-06-13
N209354-001	11679115	2036-06-06	U-2625	Drug product	2023-07-13

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	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N209354-001	DUOBRII	0.01%;0.045%	LOTION / TOPICAL	AB	RLD, RS	2019-04-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209354-001	DUOBRII	0.01%;0.045%	LOTION / TOPICAL	AB	RLD, RS	2019-04-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209354-001	DUOBRII	0.01%;0.045%	LOTION / TOPICAL	AB	RLD, RS	2019-04-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209354-001	DUOBRII	0.01%;0.045%	LOTION / TOPICAL	AB	RLD, RS	2019-04-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209354-001	DUOBRII	0.01%;0.045%	LOTION / TOPICAL		RLD, RS	2019-04-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209354-001	DUOBRII	0.01%;0.045%	LOTION / TOPICAL		RLD, RS	2019-04-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209354-001	DUOBRII	0.01%;0.045%	LOTION / TOPICAL		RLD, RS	2019-04-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209354-001	DUOBRII	0.01%;0.045%	LOTION / TOPICAL		RLD, RS	2019-04-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209354-001	DUOBRII	0.01%;0.045%	LOTION / TOPICAL		RLD, RS	2019-04-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209354-001	DUOBRII	0.01%;0.045%	LOTION / TOPICAL		RLD, RS	2019-04-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209354-001	DUOBRII	0.01%;0.045%	LOTION / TOPICAL		RLD, RS	2019-04-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209354-001	DUOBRII	0.01%;0.045%	LOTION / TOPICAL		RLD, RS	2019-04-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209354-001	DUOBRII	0.01%;0.045%	LOTION / TOPICAL		RLD, RS	2019-04-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209354-001	DUOBRII	0.01%;0.045%	LOTION / TOPICAL		RLD, RS	2019-04-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209354-001	DUOBRII	0.01%;0.045%	LOTION / TOPICAL		RLD, RS	2019-04-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209354-001	DUOBRII	0.01%;0.045%	LOTION / TOPICAL		RLD, RS	2019-04-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209354-001	DUOBRII	0.01%;0.045%	LOTION / TOPICAL		RLD, RS	2019-04-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209354-001	DUOBRII	0.01%;0.045%	LOTION / TOPICAL		RLD, RS	2019-04-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209354-001	DUOBRII	0.01%;0.045%	LOTION / TOPICAL		RLD, RS	2019-04-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209354-001	DUOBRII	0.01%;0.045%	LOTION / TOPICAL		RLD, RS	2019-04-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209354-001	DUOBRII	0.01%;0.045%	LOTION / TOPICAL		RLD, RS	2019-04-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209354-001	DUOBRII	0.01%;0.045%	LOTION / TOPICAL		RLD, RS	2019-04-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209354-001	DUOBRII	0.01%;0.045%	LOTION / TOPICAL		RLD, RS	2019-04-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209354-001	DUOBRII	0.01%;0.045%	LOTION / TOPICAL		RLD, RS	2019-04-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209354-001	DUOBRII	0.01%;0.045%	LOTION / TOPICAL		RLD, RS	2019-04-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N209354-001	DUOBRII	0.01%;0.045%	LOTION / TOPICAL		RLD, RS	2019-04-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N209354-001	DUOBRII	0.01%;0.045%	LOTION / TOPICAL		RLD, RS	2019-04-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N209354-001	DUOBRII	0.01%;0.045%	LOTION / TOPICAL		RLD, RS	2019-04-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N209354-001	DUOBRII	0.01%;0.045%	LOTION / TOPICAL		RLD, RS	2019-04-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N209354-001	DUOBRII	0.01%;0.045%	LOTION / TOPICAL		RLD, RS	2019-04-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N209354-001	DUOBRII	0.01%;0.045%	LOTION / TOPICAL		RLD, RS	2019-04-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N209354-001	DUOBRII	0.01%;0.045%	LOTION / TOPICAL		RLD, RS	2019-04-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N209354-001	DUOBRII	0.01%;0.045%	LOTION / TOPICAL		RLD, RS	2019-04-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N209354-001	DUOBRII	0.01%;0.045%	LOTION / TOPICAL		RLD, RS	2019-04-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N209354-001	DUOBRII	0.01%;0.045%	LOTION / TOPICAL		RLD, RS	2019-04-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N209354-001	DUOBRII	0.01%;0.045%	LOTION / TOPICAL		RLD, RS	2019-04-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N209354-001	DUOBRII	0.01%;0.045%	LOTION / TOPICAL		RLD, RS	2019-04-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N209354-001	DUOBRII	0.01%;0.045%	LOTION / TOPICAL		RLD, RS	2019-04-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N209354-001	DUOBRII	0.01%;0.045%	LOTION / TOPICAL		RLD, RS	2019-04-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N209354-001	DUOBRII	0.01%;0.045%	LOTION / TOPICAL		RLD, RS	2019-04-25	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N209354-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209354-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209354-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209354-001	AB	1	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N209354-001	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 7 · 271 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	N209354-001	10478502	2031-11-02	U-2625	Drug product	2019-11-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209354-001	11839656	2031-11-02	U-2625		2024-01-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209354-001	11957753	2031-11-02		Drug product	2024-05-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209354-001	11986527	2031-11-02	U-2625		2024-06-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209354-001	12076403	2031-11-02		Drug product	2024-09-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209354-001	8809307	2031-11-02		Drug product	2019-04-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209354-001	10251895	2036-06-06		Drug product	2019-04-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209354-001	10426787	2036-06-06	U-2625		2019-10-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209354-001	11648256	2036-06-06	U-2625	Drug product	2023-06-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209354-001	11679115	2036-06-06	U-2625	Drug product	2023-07-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209354-001	10478502	2031-11-02	U-2625	Drug product	2019-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209354-001	11839656	2031-11-02	U-2625		2024-01-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209354-001	11957753	2031-11-02		Drug product	2024-05-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209354-001	11986527	2031-11-02	U-2625		2024-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209354-001	12076403	2031-11-02		Drug product	2024-09-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209354-001	8809307	2031-11-02		Drug product	2019-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209354-001	10251895	2036-06-06		Drug product	2019-04-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209354-001	10426787	2036-06-06	U-2625		2019-10-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209354-001	11648256	2036-06-06	U-2625	Drug product	2023-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209354-001	11679115	2036-06-06	U-2625	Drug product	2023-07-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209354-001	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	N209354-001	11839656	2031-11-02	U-2625		2024-01-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209354-001	11957753	2031-11-02		Drug product	2024-05-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209354-001	11986527	2031-11-02	U-2625		2024-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209354-001	12076403	2031-11-02		Drug product	2024-09-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209354-001	8809307	2031-11-02		Drug product	2019-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209354-001	10251895	2036-06-06		Drug product	2019-04-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209354-001	10426787	2036-06-06	U-2625		2019-10-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209354-001	11648256	2036-06-06	U-2625	Drug product	2023-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209354-001	11679115	2036-06-06	U-2625	Drug product	2023-07-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209354-001	10478502	2031-11-02	U-2625	Drug product	2019-11-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209354-001	11839656	2031-11-02	U-2625		2024-01-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209354-001	11957753	2031-11-02		Drug product	2024-05-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209354-001	11986527	2031-11-02	U-2625		2024-06-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209354-001	12076403	2031-11-02		Drug product	2024-09-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209354-001	8809307	2031-11-02		Drug product	2019-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209354-001	10251895	2036-06-06		Drug product	2019-04-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209354-001	10426787	2036-06-06	U-2625		2019-10-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209354-001	11648256	2036-06-06	U-2625	Drug product	2023-06-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209354-001	11679115	2036-06-06	U-2625	Drug product	2023-07-13	`6a471c1ec25d…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209354-001	NP	2022-04-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209354-001	NP	2022-04-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209354-001	NP	2022-04-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209354-001	NP	2022-04-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209354-001	NP	2022-04-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209354-001	NP	2022-04-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209354-001	NP	2022-04-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209354-001	NP	2022-04-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209354-001	NP	2022-04-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209354-001	NP	2022-04-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N209354-001	NP	2022-04-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N209354-001	NP	2022-04-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N209354-001	NP	2022-04-25	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	N209354-001	NP	2022-04-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N209354-001	NP	2022-04-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N209354-001	NP	2022-04-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N209354-001	NP	2022-04-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N209354-001	NP	2022-04-25	`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
Duobrii	HALOBETASOL PROPIONATE AND TAZAROTENE	Bausch Health US, LLC	b3f0cdc0-69fd-43d1-baf2-d776a3a20715	2020-01-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 209354 application number: NDA209354 ndc (product): 0187-0653

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
0187-0653	Duobrii	halobetasol propionate and tazarotene	Bausch Health US, LLC	NDA	Current
0187-0653	Duobrii	halobetasol propionate and tazarotene	Bausch Health US, LLC	NDA	Current
0187-0653	Duobrii	halobetasol propionate and tazarotene	Bausch Health US, LLC	NDA	Current
0187-0653	Duobrii	halobetasol propionate and tazarotene	Valeant Pharmaceuticals North America LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
61551	ORIG	2020-01-10
58456	ORIG	2019-04-29
58442	ORIG	2019-04-26