CLONIDINE | N022500 | ROSEMONT PHARMACEUTICALS LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from ANDA Consultants FDA-2017-P-5335 ANDA Consultants filed this citizen petition on August 29, 2017, requesting that the FDA determine whether Nexiclon XR (clonidine) Extended Release Tablets at 0.17 mg and 0.26 mg, approved under NDA 22-500 and manufactured by Tris Pharma Inc., was withdrawn from marketing for safety or effectiveness | 505(q) | 2017-08-30 | Open | ANDA Consultants |
Source: Regulations.gov. FDA citizen petitions matched by application number.