LIDOCAINE | A080198 | FOUGERA PHARMACEUTICALS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Quagen Pharmaceuticals LLC FDA-2017-P-5080 · 4 docket documents Quagen Pharmaceuticals LLC filed this citizen petition under section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA designate Lidocaine Ointment 5% manufactured by Fougera Pharmaceuticals Inc (ANDA 080198) as a Reference Listed Drug in the Orange Book. The petitioner seek | Other | 2017-08-22 | Withdrawn | Quagen Pharmaceuticals LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.1574
per gm
Lowest NADAC/Unit
$0.1574
per gm
Brand NDCs
0
Generic NDCs
1
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00168020437LIDOCAINE 5% OINTMENT | $0.1574 | 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.