NDA 11161, held by Astellas. Triamcinolone.
As of Nov 14, 2026, NDA 11161 (Aristocort), held by Astellas, was first approved by FDA on Dec 3, 1957, with 12 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 3, 1957 | Original applicationNew molecular entity · Priority review | Approved | None posted |
| Aristocort2MG · tablet;oral | Triamcinolone | Discontinued |
| Aristocort4MG · tablet;oral | Triamcinolone | Discontinued |
| Aristocort1MG · tablet;oral | Triamcinolone | Discontinued |
| Aristocort16MG · tablet;oral | Triamcinolone | Discontinued |
| Aristocort8MG · tablet;oral | Triamcinolone | Discontinued |
| Mar 13, 2009 | Supplement 47Labeling | Approved | None posted |
| Mar 13, 2009 | Supplement 44Labeling | Approved | None posted |
| Mar 13, 2009 | Supplement 39Labeling | Approved | None posted |
| Sep 17, 1999 | Supplement 51Manufacturing · Priority review | Approved | None posted |
| Oct 18, 1994 | Supplement 50Manufacturing · Priority review | Approved | None posted |
| Mar 30, 1994 | Supplement 48Manufacturing · Priority review | Approved | None posted |
| Sep 7, 1993 | Supplement 49Labeling | Approved | None posted |
| Nov 29, 1986 | Supplement 45Manufacturing · Priority review | Approved | None posted |
| Sep 25, 1986 | Supplement 46Manufacturing · Priority review | Approved | None posted |
| Jun 11, 1982 | Supplement 43Manufacturing · Priority review | Approved | None posted |
| Apr 27, 1981 | Supplement 42Manufacturing · Priority review | Approved | None posted |
| Aug 6, 1979 | Supplement 40Manufacturing · Priority review | Approved | None posted |
| Dec 3, 1957 | Original applicationNew molecular entity · Priority 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
