ANDA 78975, held by Epic Pharma LLC. Ciclopirox.
As of Nov 15, 2026, ANDA 78975 (Ciclopirox), held by Epic Pharma LLC, was first approved by FDA on Feb 17, 2010, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 17, 2010 | Original application | Approved | None posted |
| 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
