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 · 16 docket documents 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, Kaplan and Becker, LLP) |
Citizen Petition from Kleinfeld Kaplan & Becker, LLP (KKB) FDA-2015-P-2120 · 10 docket documents Kleinfeld Kaplan & Becker, LLP, on behalf of Purdue Pharma L.P., filed this citizen petition under 21 C.F.R. sections 10.30, 314.50(i), 314.52, 314.54, and Section 505(b) of the Federal Food, Drug, and Cosmetic Act concerning Pfizer's Section 505(b)(2) NDA for AL0-02 (oxycodone extended-release). Pu | 505(q) | 2015-06-15 | Denied | Kleinfeld Kaplan & Becker, LLP (KKB) |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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