NDA 18116, held by Astellas. Amcinonide.
As of Nov 13, 2026, NDA 18116 (Cyclocort), held by Astellas, was first approved by FDA on Oct 18, 1979, with 9 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 18, 1979 | Original applicationNew molecular entity · Standard review | Approved | None posted |
| Cyclocort0.025% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · cream;topical | Amcinonide | DiscontinuedReference drug |
| Cyclocort0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · cream;topical | Amcinonide | DiscontinuedReference drug |
| Mar 13, 2009 | Supplement 4Labeling | Approved | None posted |
| Mar 13, 2009 | Supplement 1Labeling | Approved | None posted |
| Jun 16, 1999 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Sep 24, 1998 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Sep 23, 1998 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Sep 23, 1998 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Feb 2, 1989 | Supplement 5Labeling | Approved | None posted |
| Aug 26, 1986 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| May 9, 1985 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Oct 18, 1979 | Original applicationNew molecular entity · Standard review | 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
