Treats interdigital tinea pedis and tinea corporis due to Trichophyton rubrum…. ANDA 91595, held by Glenmark Pharms. Ciclopirox.
As of Nov 15, 2026, ANDA 91595 (Ciclopirox), held by Glenmark Pharms, was first approved by FDA on Feb 29, 2012, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE Superficial Dermatophyte Infections Ciclopirox gel 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 is indicated for the topical treatment of seborrheic dermatitis of the scalp.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 29, 2012 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ciclopirox0.77% · gel;topical | Ciclopirox | Rx |
| Dec 1, 2014 | Supplement 1Labeling · Standard review | Approved | None posted |
| Feb 29, 2012 | 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
