EPINEPHRINE | N204640 | 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. | 2024-09-24 | Terminated 2024-11-27 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from DifGen Pharmaceuticals, LLC FDA-2025-P-1280 · 7 docket documents DifGen Pharmaceuticals LLC filed a citizen petition under 21 CFR § 10.30 requesting that the FDA determine whether the original formulation of Adrenalin (Epinephrine) Injection, 30mg/30mL, Multiple Dose Vial, approved under NDA 204640 on December 18, 2013, was discontinued for safety or effectivenes | 505(q) | 2025-05-16 | Open | DifGen Pharmaceuticals, LLC |
Citizen Petition from Lachman Consultant Services, Inc FDA-2022-P-0476 · 4 docket documents Lachman Consultant Services, Inc. filed this citizen petition requesting that the FDA determine whether the original formulation of ADRENALIN (Epinephrine Injection USP, 1 mg/mL in 30 mL multiple dose vials), approved under NDA 204640 by PAR STERILE PRODUCTS LLC, was voluntarily withdrawn from the m | 505(q) | 2022-03-31 | Granted | Lachman Consultant Services, Inc |
Citizen Petition from Latham & Watkins LLP on behalf of Par Sterile Products,... FDA-2019-P-6044 · 5 docket documents 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 |
Source: Regulations.gov. FDA citizen petitions matched by application number.