BIVALIRUDIN | N020873 | SANDOZ INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D.N.J. | 2016-02-02 | Terminated 2017-12-19 | — | |
| D.N.J. | 2014-04-11 | Terminated 2017-11-22 | — | |
| D.N.J. | 2013-05-01 | Terminated 2018-05-02 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| 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DYSLYZ (bivalirudin) tablets at 0.5 mg and 10 mg, listed in the Orange Book as a discontinued drug product, were withdrawn from commercial distribution or from sale for safety or effectiveness reasons unde | 505(q) | 2024-11-13 | Granted | Pharmobedient Consulting |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.