OXYCODONE HYDROCHLORIDE | N202080 | ZYLA LIFE SCIENCES US INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Acura Pharmaceuticals, Inc. FDA-2015-P-2413 Acura Pharmaceuticals, Inc. filed this citizen petition pursuant to section 505(q) and related regulatory provisions requesting that the FDA provide written confirmation that it will fully consider and substantively respond to Acura's prior petition regarding Purdue Pharma's 505(b)(2) NDA for a foll | 505(q) | 2015-07-13 | Denied | Acura Pharmaceuticals |
Citizen Petition from Acura Pharmaceuticals Inc FDA-2014-P-2188 Acura Pharmaceuticals Inc filed this citizen petition on December 10, 2014, requesting that the FDA refuse to accept or approve Purdue Pharma's 505(b)(2) new drug application for an abuse-deterrent immediate release oxycodone product unless Purdue properly references Acura's approved drug OXECTA as | 505(q) | 2014-12-12 | Denied | Acura Pharmaceuticals Inc |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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