Treats chronic, moderately severe psoriasis of the scalp. ANDA 78468, held by Cosette Pharms Nc. Calcipotriene.
As of Nov 15, 2026, ANDA 78468 (Calcipotriene), held by Cosette Pharms Nc, was first approved by FDA on Mar 24, 2011, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Calcipotriene Topical Solution, 0.005% (Scalp Solution) is indicated for the topical treatment of chronic, moderately severe psoriasis of the scalp. The safety and effectiveness of topical calcipotriene in dermatoses other than psoriasis have not been established.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 24, 2011 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Calcipotriene0.005% · solution;topical | Calcipotriene | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
