Relieves inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. ANDA 87385, held by Padagis US. Triamcinolone Acetonide.
As of Nov 15, 2026, ANDA 87385 (Triamcinolone Acetonide), held by Padagis US, was first approved by FDA on Nov 5, 1981, with 7 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 |
|---|---|---|---|
| Nov 5, 1981 | Original application | Approved | None posted |
| Triamcinolone Acetonide0.5% · ointment;topical | Triamcinolone Acetonide | RxReference drug |
| Triamcinolone Acetonide0.025% · ointment;topical | Triamcinolone Acetonide | RxReference drug |
| Triamcinolone Acetonide0.1% · ointment;topical | Triamcinolone Acetonide | RxReference drug |
| Mar 26, 1999 | Supplement 15Manufacturing | Approved | None posted |
| Jun 14, 1995 | Supplement 13Labeling | Approved | None posted |
| May 13, 1988 | Supplement 12Manufacturing | Approved | None posted |
| Sep 23, 1986 | Supplement 10Manufacturing | Approved | None posted |
| Jun 9, 1986 | Supplement 9Manufacturing | Approved | None posted |
| Apr 28, 1986 | Supplement 3Manufacturing | Approved | None posted |
| Jul 11, 1984 | Supplement 4Manufacturing | Approved | None posted |
| Nov 5, 1981 | 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
