NDA 11685, held by Fosun Pharma. Triamcinolone Diacetate.
As of Nov 14, 2026, NDA 11685 (Aristocort), held by Fosun Pharma, was first approved by FDA on Mar 12, 1959, with 12 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 12, 1959 | Original applicationNew active ingredient · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Aristocort25MG/ML · injectable;injection | Triamcinolone Diacetate | Discontinued |
| Jun 5, 2024 | Supplement 27Labeling · Standard review | Approved | |
| Jul 3, 2014 | Supplement 26Labeling · Standard review | Approved | |
| Aug 29, 2001 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| Oct 25, 1999 | Supplement 23Manufacturing · Standard review | Approved | None posted |
| Nov 9, 1995 | Supplement 22Manufacturing · Standard review | Approved | None posted |
| Aug 4, 1994 | Supplement 21Manufacturing · Standard review | Approved | None posted |
| Sep 7, 1993 | Supplement 20Labeling | Approved | None posted |
| Nov 5, 1992 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Feb 6, 1992 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Feb 6, 1992 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Oct 12, 1989 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Oct 6, 1980 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Mar 12, 1959 | Original applicationNew active ingredient · 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
