Treats plaque psoriasis. ANDA 205772, held by Glenmark Speclt. Calcipotriene.
As of Nov 15, 2026, ANDA 205772 (Calcipotriene), held by Glenmark Speclt, was first approved by FDA on Jun 9, 2015, with 1 approved supplement and 0 published complete response letters.
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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 9, 2015 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Calcipotriene0.005% · cream;topical | Calcipotriene | Rx |
| Apr 17, 2026 | Supplement 7Labeling · Standard review | Approved | None posted |
| Jun 9, 2015 | Original application | Approved |
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
