ACETAMINOPHEN | N204957 | B BRAUN MEDICAL INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2017-05-31 | Terminated 2018-10-05 | — | |
| D. Del. | 2017-04-03 | Terminated 2018-10-05 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from B. Braun Medical Inc. FDA-2021-P-0278 · 4 docket documents B. Braun Medical Inc. filed a citizen petition requesting that the FDA assign a therapeutic equivalence rating to NDA 204957, B. Braun's Acetaminophen Injection, which was approved under section 505(b)(2) with Ofirmev as the reference listed drug. B. Braun contends that a bioequivalence study demons | Other | 2021-03-10 | Denied | B. Braun Medical Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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