TRIAMCINOLONE ACETONIDE | A085692 | FOUGERA PHARMACEUTICALS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2026-P-5989 · 7 docket documents On behalf of a client, Hyman, Phelps & McNamara, P.C. filed a suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that FDA declare Triamcinolone Acetonide Cream at 0.25% and 0.05% strengths suitable for submission as an Abbreviated New Drug Applicati | Suitability | 2026-05-27 | Open | Hyman, Phelps & McNamara, P.C. |
Suitability Petition from Hyman, Phelps & Mcnamara, P.C. FDA-2024-P-5165 · 8 docket documents 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 | Denied | Hyman, Phelps & Mcnamara, P.C. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.1933
per gm
Lowest NADAC/Unit
$0.0245
per gm
Brand NDCs
0
Generic NDCs
6
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00168000215TRIAMCINOLONE 0.5% CREAM | $0.1933 | GM | Generic | — | 2026-06-17 |
| 00168000315TRIAMCINOLONE 0.025% CREAM | $0.1190 | GM | Generic | — | 2026-06-17 |
| 00168000415TRIAMCINOLONE 0.1% CREAM | $0.0999 | GM | Generic | — | 2026-06-17 |
| 00168000380TRIAMCINOLONE 0.025% CREAM | $0.0531 | GM | Generic | — | 2026-06-17 |
| 00168000480TRIAMCINOLONE 0.1% CREAM | $0.0484 | GM | Generic | — | 2026-06-17 |
| 00168000416TRIAMCINOLONE 0.1% CREAM | $0.0245 | GM | Generic | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.