OXYCODONE HYDROCHLORIDE | N209777 | PROTEGA PHARMACEUTICALS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Pharmaceutical Manufacturing Research Services, Inc. FDA-2017-P-3064 Pharmaceutical Manufacturing Research Services, Inc. filed this petition on May 11, 2017, requesting that the FDA stay the effective date of approval of NDA 209777 for ROXYBOND (oxycodone hydrochloride) tablets, a Section 505(b)(2) application submitted by Inspirion Delivery Sciences, LLC, pending F | 505(q) Stay Request | 2017-05-16 | Denied | Pharmaceutical Manufacturing Research Services |
Source: Regulations.gov. FDA citizen petitions matched by application number.