OXYCODONE HYDROCHLORIDE | N202080 | ZYLA LIFE SCIENCES US INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Acura Pharmaceuticals, Inc. FDA-2015-P-2413 · 3 docket documents 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, Inc. |
Citizen Petition from Acura Pharmaceuticals Inc FDA-2014-P-2188 · 25 docket documents 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 |
Lachman Consultant Services Inc. - Citizen Petition FDA-2011-P-0744 · 4 docket documents Lachman Consultant Services Inc. filed this petition under Section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA designate Oxecta (oxycodone hydrochloride) Tablets, 5 mg and 7.5 mg, subject to NDA 202080 held by King Pharmaceuticals, as a second reference listed drug (RL | 505(q) | 2011-10-21 | Granted | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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