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 | Denied | DifGen Pharmaceuticals LLC |
Citizen Petition from Belcher Pharmaceuticals, LLC FDA-2017-P-3352 Belcher Pharmaceuticals, LLC filed this petition on May 25, 2017, requesting that the FDA amend the sulfite warning requirement in 21 C.F.R. 201.22(c) for sulfite-containing epinephrine for injection used in emergency situations to acknowledge the availability of sulfite-free epinephrine products an | Other | 2017-05-26 | Open | Belcher Pharmaceuticals |
Source: Regulations.gov. FDA citizen petitions matched by application number.