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. Ten suppliers are listed for this compound. Additional details are available on the calcipotriene profile page.
The generic ingredient in SORILUX is calcipotriene. There are twelve drug master file entries for this compound. Ten 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: | ⤷ Try a Trial | 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: | ⤷ Try a Trial | 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: | ⤷ Try a Trial | 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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