TRIAMCINOLONE ACETONIDE | A083380 | ASTELLAS PHARMA US INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Amendment to Suitability Petition from Hyman, Phelps & Mcnamara, P.C. 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 | Suitability | 2024-11-15 | Open | Hyman |
Suitability Petition from Hyman, Phelps & Mcnamara, P.C. 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 | Suitability | 2024-11-05 | Open | Hyman |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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