BENDAMUSTINE HYDROCHLORIDE | N215033 | APOTEX INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2025-01-17 | Active | — | |
| D. Del. | 2024-01-17 | Active | — | |
Eagle Pharmaceuticals, Inc. v. Slayback Pharma LLC et al 7 patentsBendamustine Hydrochloride | D. Del. | 2021-08-31 | Terminated 2022-10-25 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Apotex Inc FDA-2022-P-3206 Apotex Inc. filed this citizen petition requesting that the FDA assign a therapeutic equivalence evaluation code of "AP" to Apotex's Bendamustine Hydrochloride Injection, 100 mg/4 mL (25 mg/mL), approved under NDA No. 215033 as a 505(b)(2) application, in relation to the reference listed drug Eagle | 505(q) | 2022-12-14 | Denied | Apotex Inc |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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