FLUOCINOLONE ACETONIDE | N013960 | EUROFARMA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Arent Fox LLP FDA-2018-P-0266 · 3 docket documents Arent Fox LLP filed a citizen petition on behalf of its client under Section 505(j) of the Federal Food, Drug and Cosmetic Act requesting that the FDA amend the Orange Book to designate ANDA No. A091306 for Fluocinolone Acetonide Oil 0.01% Ear Drops owned by Identi Pharmaceuticals Inc. as a Referenc | 505(q) | 2018-01-24 | Denied | Arent Fox LLP |
Citizen Petition from Arent Fox LLP FDA-2018-P-0268 · 3 docket documents Arent Fox LLP, on behalf of Identi Pharmaceuticals Inc., filed a citizen petition under Section 505(b) of the Federal Food, Drug and Cosmetic Act requesting that the FDA amend the Orange Book to designate ANDA No. A201764/Fluocinolone Acetonide 0.01% Topical Oil (Body Oil) as the Reference Standard | Other | 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 gm
Lowest NADAC/Unit
$0.5803
per gm
Brand NDCs
0
Generic NDCs
2
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 62559029915FLUOCINOLONE 0.025% OINTMENT | $1.13 | GM | Generic | — | 2026-06-17 |
| 62559029960FLUOCINOLONE 0.025% OINTMENT | $0.5803 | 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.