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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 022563


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NDA 022563 describes SORILUX, 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 SORILUX profile page.

The generic ingredient in SORILUX is calcipotriene. There are twelve drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the calcipotriene profile page.
Summary for 022563
Tradename:SORILUX
Applicant:Mayne Pharma
Ingredient:calcipotriene
Patents:2
Pharmacology for NDA: 022563
Suppliers and Packaging for NDA: 022563
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SORILUX calcipotriene AEROSOL, FOAM;TOPICAL 022563 NDA Mayne Pharma 51862-376 51862-376-12 1 CAN in 1 CARTON (51862-376-12) / 120 g in 1 CAN
SORILUX calcipotriene AEROSOL, FOAM;TOPICAL 022563 NDA Mayne Pharma 51862-512 51862-512-60 1 CAN in 1 CARTON (51862-512-60) / 60 g in 1 CAN

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:AEROSOL, FOAM;TOPICALStrength0.005%
Approval Date:Oct 6, 2010TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:May 7, 2028Product Flag?YSubstance Flag?Delist Request?
Patented Use:USE OF A CALCIPOTRIENE CONTAINING FOAM FOR THE TREATMENT OF PSORIASIS
Patent:⤷  Sign UpPatent Expiration:May 7, 2028Product Flag?YSubstance Flag?Delist Request?
Patented Use:USE OF CALCIPOTRIENE FOAM FOR THE TOPICAL TREATMENT OF PLAQUE PSORIASIS IN PATIENTS AGED 4 YEARS AND OLDER
Patent:⤷  Sign UpPatent Expiration:May 26, 2026Product Flag?YSubstance Flag?Delist Request?
Patented Use:USE OF A CALCIPOTRIENE CONTAINING FOAM FOR THE TREATMENT OF PSORIASIS

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