Relieves inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. ANDA 89595, held by Pharmobedient. Triamcinolone Acetonide.
As of Nov 15, 2026, ANDA 89595 (Trianex), held by Pharmobedient, was first approved by FDA on Mar 23, 1995, with 4 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Triamcinolone Acetonide 0.05% in Absorbase (Triamcinolone Acetonide Ointment, USP) is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 23, 1995 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Trianex0.05% · ointment;topical | Triamcinolone Acetonide | Discontinued |
| Jul 28, 2021 | Supplement 8Manufacturing | Approved | None posted |
| Apr 20, 2017 | Supplement 3Manufacturing | Approved | None posted |
| Apr 20, 2017 | Supplement 4Labeling · Standard review | Approved | None posted |
| Sep 25, 2000 | Supplement 1Manufacturing | Approved | None posted |
| Mar 23, 1995 | 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
