EPINEPHRINE | N204200 | PH HEALTH LTD
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2025-07-10 | Active | — | |
| N.D. Ill. | 2025-03-05 | Terminated 2025-06-12 | — | |
| D. Del. | 2017-07-13 | Terminated 2019-11-14 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from DifGen Pharmaceuticals LLC FDA-2025-P-1165 DifGen Pharmaceuticals LLC submitted this citizen petition under 21 CFR § 10.30 requesting that the FDA determine whether the original formulation of the reference listed drug Adrenalin (epinephrine) injection 1mg/mL, 1mL vial approved under NDA 204200 on December 7, 2012, was discontinued for reaso | 505(q) | 2025-05-09 | Open | DifGen Pharmaceuticals LLC |
Citizen Petition from Latham & Watkins LLP on behalf of Par Sterile Products,... FDA-2019-P-6044 Latham & Watkins LLP, on behalf of Par Sterile Products, LLC, filed this petition pursuant to sections 505(b), 505(j), and 505(q) of the Federal Food, Drug, and Cosmetic Act requesting that FDA expedite its review of Par's pending Prior Approval Supplements seeking to eliminate the epinephrine overa | 505(q) Stay Request | 2019-12-26 | Denied | Par Sterile Products, LLC |
Citizen Petition from Latham & Watkins LLP FDA-2016-P-2376 Par Sterile Products, LLC filed this petition under sections 505(b), 505(j), and 505(q) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA refrain from approving any abbreviated new drug application for an epinephrine injection 1 mg/mL product unless it contains the same inactive in | 505(q) | 2016-08-02 | Denied | Latham & Watkins LLP |
Source: Regulations.gov. FDA citizen petitions matched by application number.