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Last Updated: July 6, 2020

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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 three 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. Eleven suppliers are listed for this compound. Additional details are available on the halobetasol propionate profile page.
Summary for 209355
Ingredient:halobetasol propionate
Pharmacology for NDA: 209355
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
Paragraph IV (Patent) Challenges for 209355
Tradename Dosage Ingredient NDA Submissiondate
BRYHALI LOTION;TOPICAL halobetasol propionate 209355 2019-05-15

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:LOTION;TOPICALStrength0.01%
Approval Date:Nov 6, 2018TE:RLD:Yes
Regulatory Exclusivity Expiration:Nov 6, 2021
Regulatory Exclusivity Use:NEW PRODUCT
Patent:  Start TrialPatent Expiration:Nov 2, 2031Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Aug 3, 2020Product Flag?YSubstance Flag?Delist Request?

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