Treats nail disorders, including minor nail procedures. ANDA 78172, held by Acella. Ciclopirox.
As of Nov 15, 2026, ANDA 78172 (Ciclopirox), held by Acella, was first approved by FDA on Sep 18, 2007, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE (To understand fully the indication for this product, please read the entire INDICATION AND USAGE section of the labeling.) Ciclopirox topical solution, USP 8% as a component of a comprehensive management program, is indicated as topical treatment in immunocompetent patients with mild to moderate onychomycosis of fingernails and toenails without lunula involvement, due to Trichophyton rubrum. The comprehensive management program includes removal of the unattached, infected nails as frequently as monthly, by a health care professional who has special competence in the diagnosis and treatment of nail disorders, including minor nail procedures.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 18, 2007 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ciclopirox8% · solution;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
