MELOXICAM | N210583 | BAUDAX BIO INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2021-11-09 | Terminated 2022-02-08 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Emprise Pharma, LLC FDA-2023-P-0915 Emprise Pharma, LLC filed a citizen petition under 21 CFR 10.30 requesting that the FDA Commissioner issue a statement confirming that Anjeso (meloxicam) 30 mg/mL, approved via NDA 210583 on February 20, 2020, was not discontinued due to safety or efficacy issues. Emprise seeks this clarification be | 505(q) | 2023-03-13 | Denied | Emprise Pharma |
Source: Regulations.gov. FDA citizen petitions matched by application number.