NDA 19117, held by Sun Pharma Canada. Fluocinonide.
As of Nov 14, 2026, NDA 19117 (Fluocinonide), held by Sun Pharma Canada, was first approved by FDA on Jun 26, 1984, with 14 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 26, 1984 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Fluocinonide0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ยท cream;topical | Fluocinonide | DiscontinuedReference drug |
| Nov 10, 2015 | Supplement 39Manufacturing | Approved | None posted |
| Jun 5, 2015 | Supplement 35Manufacturing | Approved | None posted |
| Oct 27, 2014 | Supplement 38Manufacturing | Approved | None posted |
| Jul 1, 2003 | Supplement 18Labeling | Approved | None posted |
| May 9, 2001 | Supplement 12Manufacturing | Approved | None posted |
| Sep 17, 1996 | Supplement 11Manufacturing | Approved | None posted |
| May 14, 1996 | Supplement 10Manufacturing | Approved | None posted |
| Sep 9, 1993 | Supplement 9Manufacturing | Approved | None posted |
| Nov 4, 1991 | Supplement 7Manufacturing | Approved | None posted |
| Apr 30, 1991 | Supplement 6Manufacturing | Approved | None posted |
| Apr 30, 1991 | Supplement 5Manufacturing | Approved | None posted |
| Feb 19, 1991 | Supplement 8Labeling | Approved | None posted |
| Jul 12, 1989 | Supplement 4Labeling | Approved | None posted |
| Mar 8, 1985 | Supplement 2Manufacturing | Approved | None posted |
| Jun 26, 1984 | 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
