PHENYLEPHRINE HYDROCHLORIDE | N207926 | ALCON RESEARCH LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from REGCON Solutions FDA-2015-P-4231 REGCON Solutions submitted a suitability petition under Section 505(j) of the Federal Food, Drug, and Cosmetic Act on November 11, 2015, requesting that the FDA declare phenylephrine hydrochloride ophthalmic solution/drops at 2.5% and 10.0% concentrations in preservative-free unit dose formulation ( | Other | 2015-11-17 | Denied | REGCON Solutions |
Citizen Petition from REGCON Solutions LLC (Akorn Inc) FDA-2015-P-1449 REGCON Solutions LLC filed this citizen petition on behalf of Akorn Inc. requesting that the FDA amend the Orange Book to designate Akorn's Phenylephrine hydrochloride ophthalmic solution/drops 2.5% and 10% (NDA 207926) as a second reference-listed drug under Section 505(j), arguing that without thi | 505(q) | 2015-05-08 | Granted | REGCON Solutions LLC (Akorn Inc) |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$9.08
per ml
Lowest NADAC/Unit
$5.27
per ml
Brand NDCs
0
Generic NDCs
2
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00065034905PHENYLEPHRINE 2.5% EYE DROP | $9.08 | ML | Generic | — | 2026-10-21 |
| 00065034302PHENYLEPHRINE 10% EYE DROP | $5.27 | ML | Generic | — | 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.