Treats interdigital tinea pedis and tinea corporis due to Trichophyton rubrum…. ANDA 78266, held by Padagis US. Ciclopirox.
As of Nov 15, 2026, ANDA 78266 (Ciclopirox), held by Padagis US, was first approved by FDA on Jan 7, 2009, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE Superficial Dermatophyte Infections Ciclopirox Gel, 0.77% is indicated for the topical treatment of interdigital tinea pedis and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum. Seborrheic Dermatitis Ciclopirox Gel, 0.77% is indicated for the topical treatment of seborrheic dermatitis of the scalp.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 7, 2009 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ciclopirox0.77% · gel;topical | Ciclopirox | Rx |
| Oct 14, 2015 | Supplement 2Labeling · Standard review | Approved | None posted |
| Jan 7, 2009 | Original application | Approved | None posted |
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
