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calcipotriene

FDA Drug Profile — calcipotriene, SORILUX

Drug Details

Generic Name: calcipotriene
Brand Names: calcipotriene, SORILUX
Application Number: ANDA205772
Sponsor: Northstar Rx LLC
NDC Codes: 5
Dosage Forms: CREAM, OINTMENT, AEROSOL, FOAM
Routes: TOPICAL
Active Ingredients: CALCIPOTRIENE

Indications and Usage

INDICATION AND USAGE Indicated for the treatment of plaque psoriasis. INDICATIONS AND USAGE Calcipotriene cream, 0.005%, is indicated for the treatment of plaque psoriasis. The safety and effectiveness of topical calcipotriene in dermatoses other than psoriasis have not been established.

Warnings

WARNINGS FOR EXTERNAL USE ONLY. Avoid contact with eyes, lips or mucous membranes. WARNINGS Contact dermatitis, including allergic contact dermatitis, has been observed with the use of calcipotriene cream.