Details for New Drug Application (NDA): 210566
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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: | RX | Dosage: | AEROSOL, FOAM;TOPICAL | Strength | 0.05% | ||||
Approval Date: | May 24, 2018 | TE: | AB | RLD: | Yes | ||||
Regulatory Exclusivity Expiration: | Aug 18, 2024 | ||||||||
Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | May 30, 2037 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Nov 30, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | FOR THE TOPICAL TREATMENT OF PLAQUE PSORIASIS IN PATIENTS 18 YEARS OF AGE AND OLDER |
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