NDA 18498, held by Astellas. Amcinonide.
As of Nov 13, 2026, NDA 18498 (Cyclocort), held by Astellas, was first approved by FDA on Nov 13, 1981, with 11 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 13, 1981 | Original applicationNew dosage form · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cyclocort0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · ointment;topical | Amcinonide | DiscontinuedReference drug |
| Mar 13, 2009 | Supplement 4Labeling | Approved | None posted |
| Sep 3, 2002 | Supplement 8Labeling · Standard review | Approved | |
| Aug 11, 1999 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Jun 16, 1999 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Sep 4, 1998 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Aug 9, 1995 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Nov 29, 1991 | 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 |
| Mar 18, 1982 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Nov 13, 1981 | Original applicationNew dosage form · 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
