EPINEPHRINE | N205029 | BPI LABS LLC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Belcher Pharmaceuticals, LLC v. International Medication Systems, Limited 1 patentEpinephrine | D. Del. | 2018-06-28 | Terminated 2022-03-28 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
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.
No patent or exclusivity listings for this strength.
BPI Labs' Epinephrine (NDA 205029, supplement 005) received an AP therapeutic equivalence rating, indicating FDA approval as therapeutically equivalent to the reference product.
New: AP