ANDA 209596, held by Chartwell Rx. Fluocinolone Acetonide.
As of Nov 15, 2026, ANDA 209596 (Fluocinolone Acetonide), held by Chartwell Rx, was first approved by FDA on Dec 26, 2017, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 26, 2017 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Fluocinolone Acetonide0.01% ยท solution;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
