ANDA 88820, held by Astellas. Triamcinolone Acetonide.
As of Nov 15, 2026, ANDA 88820 (Aristocort A), held by Astellas, was first approved by FDA on Oct 16, 1984, with 8 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 16, 1984 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Aristocort A0.5% ยท cream;topical | Triamcinolone Acetonide | Discontinued |
| May 6, 1998 | Supplement 7Manufacturing | Approved | None posted |
| May 6, 1998 | Supplement 8Manufacturing | Approved | None posted |
| May 6, 1998 | Supplement 9Manufacturing | Approved | None posted |
| May 6, 1998 | Supplement 10Manufacturing | Approved | None posted |
| May 20, 1991 | Supplement 6Manufacturing | Approved | None posted |
| Dec 8, 1989 | Supplement 3Manufacturing | Approved | None posted |
| Dec 8, 1989 | Supplement 4Manufacturing | Approved | None posted |
| Dec 8, 1989 | Supplement 5Labeling | Approved | None posted |
| Oct 16, 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