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 Hyman, Phelps & McNamara, P.C. filed a suitability petition requesting that the FDA determine whether a particular drug substance or product formulation is suitable for use in an NDA or ANDA, though the specific drug name, product type, and detailed regulatory relief sought are not provided in the a | 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 | DeniedDecision letter not yet read | Hyman, Phelps & Mcnamara, P.C. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.1889
per gm
Lowest NADAC/Unit
$0.0247
per gm
Brand NDCs
0
Generic NDCs
6
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00168000215TRIAMCINOLONE 0.5% CREAM | $0.1889 | GM | Generic | — | 2026-08-19 |
| 00168000315TRIAMCINOLONE 0.025% CREAM | $0.1159 | GM | Generic | — | 2026-08-19 |
| 00168000415TRIAMCINOLONE 0.1% CREAM | $0.1002 | GM | Generic | — | 2026-08-19 |
| 00168000380TRIAMCINOLONE 0.025% CREAM | $0.0528 | GM | Generic | — | 2026-08-19 |
| 00168000480TRIAMCINOLONE 0.1% CREAM | $0.0465 | GM | Generic | — | 2026-08-19 |
| 00168000416TRIAMCINOLONE 0.1% CREAM | $0.0247 | GM | Generic | — | 2026-08-19 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.