BIVALIRUDIN | N211215 | MAIA PHARMACEUTICALS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Pharmobedient Consulting FDA-2024-P-5304 · 4 docket documents Pharmobedient Consulting filed this citizen petition requesting that the FDA determine whether DYSLYZ (bivalirudin) tablets at 0.5 mg and 10 mg, listed in the Orange Book as a discontinued drug product, were withdrawn from commercial distribution or from sale for safety or effectiveness reasons unde | 505(q) | 2024-11-13 | Granted | Pharmobedient Consulting |
Source: Regulations.gov. FDA citizen petitions matched by application number.