Details for New Drug Application (NDA): 022563
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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 |
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: | RX | Dosage: | AEROSOL, FOAM;TOPICAL | Strength | 0.005% | ||||
Approval Date: | Oct 6, 2010 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | May 7, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | USE OF A CALCIPOTRIENE CONTAINING FOAM FOR THE TREATMENT OF PSORIASIS | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | May 7, 2028 | Product Flag? | Y | Substance 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 Up | Patent Expiration: | May 26, 2026 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | USE OF A CALCIPOTRIENE CONTAINING FOAM FOR THE TREATMENT OF PSORIASIS |
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