ROXICODONE

FDA-2000-P-0580 · 4 docket documents

King & Spalding filed this citizen petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA Commissioner declare that abbreviated new drug applications may be submitted for combination oxycodone hydrochloride/acetaminophen tablet products in four streng

FDA-2005-P-0009 · 7 docket documents

Lachman Consultant Services, Inc. submitted this petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine that an Abbreviated New Drug Application may be submitted for Oxycodone Hydrochloride 7.5 mg Tablets, a new dosage strength based on the

FDA-1999-P-3513 · 5 docket documents

King & Spalding filed this Section 505(j)(2)(C) citizen petition requesting that the FDA determine a liquid formulation containing 7.5 mg oxycodone hydrochloride and 500 mg acetaminophen per 15 mL is suitable for evaluation under an abbreviated new drug application (ANDA), based on the approved tabl

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

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

FDA-2013-P-0425 · 3 docket documents

Rhodes Technologies, through counsel, filed this citizen petition pursuant to sections 355 and 701 of the Federal Food, Drug, and Cosmetic Act requesting that the FDA maintain the current limit of not more than 10 parts per million of 14-hydroxycodeinone impurity in oxycodone hydrochloride active ph

FDA-2001-P-0238 · 5 docket documents

Lachman Consultant Services, Inc. filed this petition on behalf of a client requesting that the FDA determine whether Oxycontin (Oxycodone Hydrochloride) Extended-Release Tablets 160 mg, approved under NDA 20-553 and manufactured by Purdue Fredrick, Inc., was voluntarily withdrawn from marketing for

FDA-2012-P-1180 · 4 docket documents

Lannett Company, Inc. filed this petition under Section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA Commissioner determine that an Abbreviated New Drug Application for Oxycodone Hydrochloride Extended-Release Capsules may be submitted and considered bioequivalent to th

FDA-2012-P-0939 · 6 docket documents

Purdue Pharma L.P. filed this citizen petition pursuant to 21 C.F.R. §§ 10.30, 314.94, 314.127, and Section 505 of the Federal Food, Drug, and Cosmetic Act requesting that FDA require all abbreviated new drug applications citing the reformulated OxyContin (NDA # 22-272, oxycodone hydrochloride exten

FDA-2012-P-1009 · 3 docket documents

Pfizer Inc., as the successor in interest to King Pharmaceuticals and sponsor of the Oxecta (oxycodone hydrochloride) NDA 20-2080, filed this citizen petition on September 21, 2012, requesting that the FDA refrain from permitting abbreviated new drug applications to rely on Oxecta as a reference lis

FDA-2012-P-0760 · 3 docket documents

Purdue Pharma L.P. filed this citizen petition under 21 C.F.R. §§ 10.30, 314.94, 314.127, Part 320, and Section 505 of the FDCA regarding abbreviated new drug applications citing reformulated OxyContin (oxycodone hydrochloride extended-release) NDA #22-272 as the Reference Listed Drug. Purdue reques

FDA-2012-P-0189 · 6 docket documents

Lannett Company Inc. and its subsidiary Cody Laboratories Inc. filed this citizen petition under Sections 201 and 505 of the Federal Food, Drug, and Cosmetic Act requesting that the FDA affirm the grandfather status of oxycodone hydrochloride (Lannett's Oxycodone Hydrochloride Oral Concentrate Solut

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

FDA-2010-P-0526 · 14 docket documents

Lachman Consultant Services, Inc. filed this citizen petition pursuant to 21 CFR 10.30 and 314.161, requesting that the FDA determine whether Oxycontin (oxycodone hydrochloride) Extended-release Tablets in strengths of 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg, 80 mg, and 160 mg (NDA 20-553) by Purdu

FDA-2010-P-0393 · 8 docket documents

The Troy and Alana Pack Foundation and affiliated organizations filed this citizen petition under 21 CFR 10.30 and 21 USC § 355 requesting that the FDA issue a public statement clarifying that there is insufficient clinical evidence to support claims that the reformulated OxyContin (controlled-relea

FDA-2009-P-0399 · 6 docket documents

Regulus Pharmaceutical Consulting, Inc. filed this citizen petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Oxycodone Hydrochloride Tablets 2.5 mg suitable for submission as an abbreviated new drug application (ANDA), with Roxicodone (Oxy

FDA-2009-P-0203 · 5 docket documents

Lachman Consultant Services, Inc., filed this citizen petition on behalf of an unnamed client pursuant to Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Oxycodone Hydrochloride and Acetaminophen Effervescent Tablets in strengths of 2.5 mg/500 mg, 5 m

FDA-2008-P-0598 · 6 docket documents

Vintage Pharmaceuticals filed this suitability petition on November 14, 2008, pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act, requesting that the FDA declare Oxycodone Hydrochloride Capsules, 5 mg suitable for submission under an Abbreviated New Drug Application, with th

FDA-1999-P-2921 · 12 docket documents

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

FDA-2007-P-0352 · 4 docket documents

On May 22, 2007, Sheppard Mullin Richter & Hampton LLP filed a citizen petition on behalf of Purdue Pharma LP requesting that the FDA determine that oxycodone hydrochloride extended release tablets in 15mg, 30mg, and 60mg strengths (NDA No. 020553) were voluntarily withdrawn for reasons other than s