Relieves inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. ANDA 89129, held by Cosette Pharms Nc. Triamcinolone Acetonide.
As of Nov 15, 2026, ANDA 89129 (Triamcinolone Acetonide), held by Cosette Pharms Nc, was first approved by FDA on Aug 14, 1986, with 9 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 14, 1986 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Triamcinolone Acetonide0.1% · lotion;topical | Triamcinolone Acetonide | Rx |
| Mar 23, 2000 | Supplement 14Manufacturing | Approved | None posted |
| Mar 23, 2000 | Supplement 15Manufacturing | Approved | None posted |
| Apr 8, 1993 | Supplement 13Labeling | Approved | None posted |
| Mar 29, 1993 | Supplement 11Labeling | Approved | None posted |
| Dec 3, 1991 | Supplement 9Labeling | Approved | None posted |
| Mar 5, 1991 | Supplement 8Labeling | Approved | None posted |
| Jan 3, 1990 | Supplement 7Manufacturing | Approved | None posted |
| Feb 9, 1989 | Supplement 6Labeling | Approved | None posted |
| Apr 21, 1988 | Supplement 4Labeling | Approved | None posted |
| Aug 14, 1986 | 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