OXCARBAZEPINE | N021285 | NOVARTIS PHARMACEUTICALS CORP
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Supernus Pharmaceuticals (Ropes and Gray, LLP) FDA-2015-P-2830 · 22 docket documents Supernus Pharmaceuticals filed this citizen petition pursuant to Section 505 of the Federal Food, Drug, and Cosmetic Act and 21 C.F.R. § 10.30 requesting that FDA establish specific bioequivalence parameters, including partial area under the curve measurements at 0-T and T-t with 90-125% confidence | 505(q) | 2015-08-10 | Denied | Supernus Pharmaceuticals (Ropes and Gray, LLP) |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$1.93
per ml
Lowest NADAC/Unit
$1.93
per ml
Brand NDCs
1
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00078035752TRILEPTAL 300 MG/5 ML SUSP | $1.93 | ML | Brand | $0.1244 | 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.