Treats plaque psoriasis. ANDA 90633, held by Glenmark Pharms. Calcipotriene.
As of Nov 15, 2026, ANDA 90633 (Calcipotriene), held by Glenmark Pharms, was first approved by FDA on Mar 24, 2010, with 3 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Calcipotriene ointment USP, 0.005%, is indicated for the treatment of plaque psoriasis in adults. The safety and effectiveness of topical calcipotriene in dermatoses other than psoriasis have not been established.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 24, 2010 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Calcipotriene0.005% · ointment;topical | Calcipotriene | Rx |
| May 24, 2019 | Supplement 5Labeling · Standard review | Approved | None posted |
| May 24, 2019 | Supplement 6Labeling · Standard review | Approved | None posted |
| Aug 13, 2015 | Supplement 1Manufacturing | Approved | None posted |
| Mar 24, 2010 | 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
