Details for New Drug Application (NDA): 209355

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NDA 209355 describes BRYHALI, which is a drug marketed by Bausch and is included in one NDA. It is available from one supplier. There are six patents protecting this drug. Additional details are available on the BRYHALI profile page.

The generic ingredient in BRYHALI is halobetasol propionate. There are nine drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the halobetasol propionate profile page.

Summary for 209355

Tradename:	BRYHALI
Applicant:	Bausch
Ingredient:	halobetasol propionate
Patents:	6

Pharmacology for NDA: 209355

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Suppliers and Packaging for NDA: 209355

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BRYHALI	halobetasol propionate	LOTION;TOPICAL	209355	NDA	Bausch Health US, LLC	0187-0002	0187-0002-01	1 TUBE in 1 CARTON (0187-0002-01) / 100 g in 1 TUBE
BRYHALI	halobetasol propionate	LOTION;TOPICAL	209355	NDA	Bausch Health US, LLC	0187-0002	0187-0002-03	1 TUBE in 1 CARTON (0187-0002-03) / 3 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	LOTION;TOPICAL			Strength	0.01%
Approval Date:	Nov 6, 2018	TE:		RLD:	Yes
Patent:	⤷ Get Started Free	Patent Expiration:	Nov 2, 2031	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	TOPICAL TREATMENT OF PLAQUE PSORIASIS IN ADULTS
Patent:	⤷ Get Started Free	Patent Expiration:	Nov 2, 2031	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TOPICAL TREATMENT OF PLAQUE PSORIASIS IN ADULTS
Patent:	⤷ Get Started Free	Patent Expiration:	Nov 2, 2031	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 209355

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	BRYHALI	halobetasol propionate	LOTION;TOPICAL	209355-001	Nov 6, 2018	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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