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. It is available from one supplier. 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.
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 |
Pharmacology for NDA: 210566
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 210566
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LEXETTE | halobetasol propionate | AEROSOL, FOAM;TOPICAL | 210566 | NDA | Mayne Pharma | 51862-604 | 51862-604-33 | 1 CANISTER in 1 CARTON (51862-604-33) / 17 g in 1 CANISTER |
| LEXETTE | halobetasol propionate | AEROSOL, FOAM;TOPICAL | 210566 | NDA | Mayne Pharma | 51862-604 | 51862-604-50 | 1 CANISTER in 1 CARTON (51862-604-50) / 50 g in 1 CANISTER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | AEROSOL, FOAM;TOPICAL | Strength | 0.05% | ||||
| Approval Date: | May 24, 2018 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Aug 18, 2024 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
| Patent: | See Plans and Pricing | Patent Expiration: | May 30, 2037 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| Patent: | See Plans and Pricing | 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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