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Generated: May 24, 2017

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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 two suppliers. 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. Fourteen suppliers are listed for this compound. Additional details are available on the calcipotriene profile page.

Summary for NDA: 022563

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Dermatological Agents

Pharmacology for NDA: 022563

Ingredient-typeVitamin D

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 Stiefel Laboratories Inc 0145-2130 0145-2130-06 1 CAN in 1 CARTON (0145-2130-06) > 60 g in 1 CAN
SORILUX
calcipotriene
AEROSOL, FOAM;TOPICAL 022563 NDA Stiefel Laboratories Inc 0145-2130 0145-2130-07 1 CAN in 1 CARTON (0145-2130-07) > 120 g in 1 CAN

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:AEROSOL, FOAM;TOPICALStrength0.005%
Approval Date:Oct 6, 2010TE:RLD:Yes
Patent:8,263,580Patent Expiration:Sep 27, 2028Product Flag?YSubstance Flag?Delist Request?
Patented Use:USE OF A CALCIPOTRIENE CONTAINING FOAM FOR THE TREATMENT OF PSORIASIS
Patent:8,629,128Patent Expiration:May 26, 2026Product Flag?YSubstance Flag?Delist Request?
Patented Use:USE OF A CALCIPOTRIENE CONTAINING FOAM FOR THE TREATMENT OF PSORIASIS
Patent:8,629,128Patent Expiration:May 26, 2026Product Flag?YSubstance Flag?Delist Request?
Patented Use:USE OF CALCIPOTRIENE FOAM FOR THE TOPICAL TREATMENT OF PLAQUE PSORIASIS IN PATIENTS AGED 18 YEARS AND OLDER


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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