Treats seborrheic dermatitis of the scalp. ANDA 209975, held by Encube. Ciclopirox.
As of Nov 15, 2026, ANDA 209975 (Ciclopirox), held by Encube, was first approved by FDA on Apr 5, 2018, with 0 approved supplements and 0 published complete response letters.
Ciclopirox shampoo, 1 % is indicated for the topical treatment of seborrheic dermatitis of the scalp in adults.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 5, 2018 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ciclopirox1% · shampoo;topical | Ciclopirox | 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
