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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 210566


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NDA 210566 describes LEXETTE, which is a drug marketed by Mayne Pharma and is included in one NDA. There are two patents protecting this drug. Additional details are available on the LEXETTE profile page.

The generic ingredient in LEXETTE is halobetasol propionate. There are nine drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the halobetasol propionate profile page.
Summary for 210566
Tradename:LEXETTE
Applicant:Mayne Pharma
Ingredient:halobetasol propionate
Patents:2

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:AEROSOL, FOAM;TOPICALStrength0.05%
Approval Date:May 24, 2018TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Aug 18, 2024
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Patent:⤷  Sign UpPatent Expiration:May 30, 2037Product Flag?Substance Flag?Delist Request?Y
Patent:⤷  Sign UpPatent Expiration:Nov 30, 2036Product Flag?YSubstance Flag?Delist Request?
Patented Use:FOR THE TOPICAL TREATMENT OF PLAQUE PSORIASIS IN PATIENTS 18 YEARS OF AGE AND OLDER

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