HYDROMORPHONE HYDROCHLORIDE | N019034 | FRESENIUS KABI USA LLC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Fresenius Kabi USA, LLC et al v. Eurohealth International Sarl 2 patentsANDA 202159hydromorphone hydrochloride | D. Del. | 2018-06-01 | Terminated 2018-08-14 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Apotex Inc. FDA-2026-P-2718 Apotex Inc. submitted this citizen petition pursuant to 21 CFR 10.30 and 314.161 requesting that the FDA determine whether Dilaudid-HP (hydromorphone hydrochloride) 10 mg/mL, NDA 019034, held by Fresenius Kabi USA LLC has been voluntarily withdrawn from sale for reasons of safety or efficacy, as the | 505(q) | 2026-03-17 | Withdrawn | Apotex Inc. |
Citizen Petition From Purdue Pharma LP (Kleinfeld, Kaplan and Becker, LLP) FDA-2014-P-0205 Purdue Pharma LP filed this citizen petition requesting that the FDA exercise its authority under Section 505(o) of the Federal Food, Drug and Cosmetic Act to impose safety labeling changes on immediate-release opioid analgesics parallel to those mandated for extended-release and long-acting opioid | Other | 2014-02-25 | Partially Denied | Purdue Pharma LP (Kleinfeld |
Source: Regulations.gov. FDA citizen petitions matched by application number.