Treats psoriasis of the scalp (scalp oil). ANDA 212761, held by Quagen. Fluocinolone Acetonide.
As of Nov 15, 2026, ANDA 212761 (Fluocinolone Acetonide), held by Quagen, was first approved by FDA on Apr 2, 2021, with 0 approved supplements and 0 published complete response letters.
INDICATION AND USAGE Fluocinolone acetonide topical oil, 0.01% is a low to medium potency corticosteroid indicated: In adult patients for the treatment of psoriasis of the scalp (scalp oil).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 2, 2021 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Fluocinolone Acetonide0.01% · oil;topical | Fluocinolone Acetonide | 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
