ANDA 76422, held by Fougera Pharms. Ciclopirox.
As of Nov 15, 2026, ANDA 76422 (Ciclopirox), held by Fougera Pharms, was first approved by FDA on Aug 6, 2004, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 6, 2004 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ciclopirox0.77% ยท suspension;topical | Ciclopirox | Rx |
| Jan 11, 2006 | Supplement 4Labeling | Approved | None posted |
| Aug 6, 2004 | 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
