TRIAMCINOLONE ACETONIDE

FDA-2026-P-5989

Hyman, Phelps & McNamara, P.C., on behalf of a client, filed this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that FDA declare Triamcinolone Acetonide Cream in 0.25% and 0.05% strengths suitable for submission as an ANDA, with Fougera Pharmac

FDA-2024-P-5165

The law firm Hyman, Phelps & McNamara on behalf of a client filed this amendment to a suitability petition under Section 505(j)(2)(C) of the FDC Act requesting that the FDA declare triamcinolone acetonide topical gel 0.1% suitable for submission as an ANDA, using Fougera Pharmaceuticals' triamcinolo

FDA-2024-P-5165

The law firm Hyman, Phelps & McNamara filed this suitability petition on behalf of a client requesting that FDA declare triamcinolone acetonide topical gel 1% suitable for submission as an Abbreviated New Drug Application under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act, with th

FDA-2018-P-2361

BF Innovation Inc., on behalf of Bright Future Pharmaceutical Laboratories Limited, filed this petition requesting that the FDA designate Triamcinolone Acetonide Cream 0.1% (Application No. A085692) by Fougera Pharmaceuticals Inc. as an additional Reference Listed Drug (RLD) to enable approval of ge