Treats seborrheic dermatitis of the scalp. ANDA 78594, held by Padagis US. Ciclopirox.
As of Nov 15, 2026, ANDA 78594 (Ciclopirox), held by Padagis US, was first approved by FDA on Feb 16, 2010, with 1 approved supplement and 0 published complete response letters.
Ciclopirox Shampoo, 1% is indicated for the topical treatment of seborrheic dermatitis of the scalp in adults.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 16, 2010 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ciclopirox1% · shampoo;topical | Ciclopirox | Rx |
| Oct 14, 2015 | Supplement 5Labeling · Standard review | Approved | None posted |
| Feb 16, 2010 | 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
