Treats seborrheic dermatitis of the scalp. ANDA 90490, held by Actavis Mid Atlantic. Ciclopirox.
As of Nov 15, 2026, ANDA 90490 (Ciclopirox), held by Actavis Mid Atlantic, was first approved by FDA on Nov 24, 2009, with 2 approved supplements 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 |
|---|---|---|---|
| Nov 24, 2009 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ciclopirox1% · shampoo;topical | Ciclopirox | Rx |
| Apr 18, 2014 | Supplement 3Labeling · Standard review | Approved | None posted |
| Apr 30, 2013 | Supplement 2Labeling · Standard review | Approved | None posted |
| Nov 24, 2009 | 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
