LIDOCAINE HYDROCHLORIDE | A040433 | SENTISS AG
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Hahn Loeser & Parks LLP FDA-2022-P-1965 · 4 docket documents Law firm Hahn Loeser & Parks LLP filed this petition requesting that the FDA Commissioner determine whether Akorn Operating Co. LLC's Xylocaine (Lidocaine Hydrochloride) Jelly 2%, approved under NDA 008816, was voluntarily withdrawn from the market for safety or effectiveness reasons. The petitioner | 505(q) | 2022-08-22 | Withdrawn | Hahn Loeser & Parks LLP |
Citizen Petition from Lachman Consulting Services, Inc. FDA-2020-P-2013 · 3 docket documents Lachman Consulting Services, Inc. filed this citizen petition requesting that FDA amend the Orange Book to designate Lidocaine Hydrochloride Topical Jelly, 2% approved under ANDA 040433 as a new Reference Standard, arguing that the current Reference Standard and Reference Listed Drug (XYLOCAINE Topi | 505(q) | 2020-09-25 | Withdrawn | Lachman Consulting Services, Inc. |
Citizen Petition from Aurolife Pharma, LLC. - Redacted Copy FDA-2020-P-1914 · 3 docket documents Aurolife Pharma LLC filed this citizen petition under Section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA designate Lidocaine Hydrochloride Jelly 2% (ANDA 040433) manufactured by Akorn Inc. as a new reference standard for developing generic versions, because the curren | 505(q) | 2020-09-17 | Withdrawn | Aurolife Pharma, LLC. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$3.27
per ml
Lowest NADAC/Unit
$3.27
per ml
Brand NDCs
0
Generic NDCs
1
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 72485061130LIDOCAINE HCL 2% JELLY | $3.27 | ML | 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.