Relieves inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. ANDA 209535, held by Macleods Pharms. Triamcinolone Acetonide.
As of Nov 15, 2026, ANDA 209535 (Triamcinolone Acetonide), held by Macleods Pharms, was first approved by FDA on May 18, 2018, with 1 approved supplement and 0 published complete response letters.
INDICATIONS & USAGE: Triamcinolone Acetonide Cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 18, 2018 | Original application | Approved | None posted |
| Triamcinolone Acetonide0.025% · cream;topical | Triamcinolone Acetonide | Rx |
| Triamcinolone Acetonide0.1% · cream;topical | Triamcinolone Acetonide | Rx |
| Triamcinolone Acetonide0.5% · cream;topical | Triamcinolone Acetonide | Rx |
| Nov 8, 2022 | Supplement 12Manufacturing | Approved | None posted |
| May 18, 2018 | 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
