NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE | N205777 | PURDUE PHARMA LP
| 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 |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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