EPINEPHRINE | N019430 | VIATRIS SPECIALTY LLC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D.N.J. | 2010-07-14 | Terminated 2011-05-10 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition From Mylan Specialty, L.P. FDA-2015-P-0181 Mylan Specialty, L.P. filed this citizen petition on January 16, 2015, under 21 USC 355 and 21 CFR 10.30, requesting that the FDA refrain from approving Teva Pharmaceuticals' ANDA 90-589 for an epinephrine auto-injector referencing EpiPen® as the reference listed drug, unless the agency determines t | 505(q) | 2015-01-20 | Denied | Mylan Specialty |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.