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 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
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.

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
2026-08-01 22:54:32	2026-06	N209354-001	DUOBRII	0.01%;0.045%	LOTION / TOPICAL	AB	RLD, RS	2019-04-25	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	N209354-001	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-01 22:54:32	2026-06	N209354-001	10478502	2031-11-02	U-2625	Drug product	2019-11-22	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209354-001	11839656	2031-11-02	U-2625		2024-01-05	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209354-001	11957753	2031-11-02		Drug product	2024-05-10	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209354-001	11986527	2031-11-02	U-2625		2024-06-13	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209354-001	12076403	2031-11-02		Drug product	2024-09-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209354-001	8809307	2031-11-02		Drug product	2019-04-30	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209354-001	10251895	2036-06-06		Drug product	2019-04-26	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209354-001	10426787	2036-06-06	U-2625		2019-10-09	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209354-001	11648256	2036-06-06	U-2625	Drug product	2023-06-13	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N209354-001	11679115	2036-06-06	U-2625	Drug product	2023-07-13	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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