ANDA 78270, held by Hikma. Ciclopirox.
As of Nov 15, 2026, ANDA 78270 (Ciclopirox), held by Hikma, was first approved by FDA on Sep 18, 2007, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 18, 2007 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ciclopirox8% ยท solution;topical | Ciclopirox | Discontinued |
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
