FLUOCINOLONE ACETONIDE | N019452 | HILL DERMACEUTICALS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Arent Fox LLP FDA-2018-P-0269 · 3 docket documents Arent Fox LLP filed this petition on behalf of Identi Pharmaceuticals Inc. requesting that the FDA amend the Orange Book to designate ANDA No. A201759 for Fluocinolone Acetonide 0.01% Topical Oil (Scalp oil) as the Reference Standard drug, replacing the current reference listed drug NDA No. N019452 | 505(q) | 2018-01-24 | Denied | Arent Fox LLP |
Hill Dermaceuticals, Inc. - Citizen Petition FDA-2004-P-0215 · 38 docket documents Hill Dermaceuticals, Inc. filed this citizen petition requesting that the FDA withhold approval of any proposed abbreviated new drug applications (ANDAs) for generic versions of DERMA-SMOOTHE/FS (fluocinolone acetonide topical oil 0.01%) until applicants conduct comprehensive safety, efficacy, bioeq | 505(q) | 2008-04-28 | Partially Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$1.13
per ml
Lowest NADAC/Unit
$0.2423
per ml
Brand NDCs
3
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 68791010320DERMOTIC OIL 0.01% EAR DROPS | $1.13 | ML | Brand | $0.9409 | 2026-04-01 |
| 68791010104DERMA-SMOOTHE-FS BODY OIL | $0.2426 | ML | Brand | $0.1784 | 2026-04-01 |
| 68791010204DERMA-SMOOTHE-FS SCALP OIL | $0.2423 | ML | Brand | $0.1707 | 2026-04-01 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.