OXYCODONE HYDROCHLORIDE | N021011 | SPECGX LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Purdue Pharma L.P. (Kleinfeld, Kaplan and Becker, LLP) FDA-2015-P-5108 Purdue Pharma L.P., through counsel, filed this citizen petition pursuant to 21 C.F.R. §§ 10.30, 314.50(i), 314.52, 314.54, and Section 505(b) of the Federal Food, Drug, and Cosmetic Act, requesting that FDA require Pfizer's 505(b)(2) NDA for AL0-02 (oxycodone extended-release tablets) to include ap | 505(q) | 2015-12-31 | Denied | Purdue Pharma L.P. (Kleinfeld |
Citizen Petition from Purdue Pharma LP FDA-1999-P-2921 Purdue Pharma LP filed this citizen petition under Section 505 of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare the October 26, 1998 approval of Roxane Laboratories' NDA 20-932 for Roxicodone (oxycodone HCl) Sustained Release Tablets null and void, arguing that the applica | 505(q) | 2008-07-02 | Granted | Purdue Pharma LP |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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