FLUOCINOLONE ACETONIDE | N019452 | HILL DERMACEUTICALS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Arent Fox LLP FDA-2018-P-0269 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 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
$0.2419
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 | $0.9066 | 2026-10-21 |
| 68791010104DERMA-SMOOTHE-FS BODY OIL | $0.2426 | ML | Brand | $0.1759 | 2026-10-21 |
| 68791010204DERMA-SMOOTHE-FS SCALP OIL | $0.2419 | ML | Brand | $0.1663 | 2026-10-21 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.