OXALIPLATIN | N021492 | SANOFI AVENTIS US LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Sicor Pharmaceuticals, Inc. FDA-2006-P-0085 · 6 docket documents Sicor Pharmaceuticals, Inc. filed this citizen petition on July 24, 2006, requesting that the FDA determine whether Sanofi Aventis's Eloxatin (Oxaliplatin for Injection) in 50 mg/vial and 100 mg/vial strengths under NDA 21-492 was voluntarily withdrawn for safety or effectiveness reasons, and to con | 505(q) | 2009-03-24 | Open | Sicor Pharmaceuticals, Inc. |
Citizen Petition from Frommer, Lawrence & Haug, LLP FDA-2006-P-0069 · 6 docket documents This document is an FDA approval letter for Sanofi-Synthelabo's NDA 21-492 for Eloxatin (oxaliplatin) for Injection, approved under accelerated approval regulations on August 9, 2002, for use in combination with infusional 5-FU/LV to treat metastatic colorectal cancer in patients whose disease recur | Other | 2009-03-17 | Open | Frommer, Lawrence & Haug, LLP |
Sanofi-aventis US LLP - Citizen Petition FDA-2006-P-0025 · 18 docket documents Sanofi-aventis US LLC filed this citizen petition under sections 505(b) and 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA require applicants seeking to market generic versions of Eloxatin (oxaliplatin injection) containing added acids or conjugate bases other than oxalic | 505(q) | 2008-11-17 | Partially Denied | — |
Strides Arcolab Limited - Citizen Petition FDA-2008-P-0461 · 3 docket documents Strides Arcolab Limited filed this citizen petition pursuant to 21 CFR 10.25 and 10.30 requesting that the FDA Commissioner determine whether Eloxatin (Oxaliplatin for Injection), 50 mg and 100 mg per vial, approved under NDA 21-492, was voluntarily withdrawn or withheld from sale for reasons of saf | 505(q) | 2008-08-21 | Withdrawn | — |
Citizen Petition from AAC Consulting Group FDA-2006-P-0006 · 6 docket documents AAC Consulting Group on behalf of a client submitted this petition under section 505(j)(2)(C) requesting that the FDA determine the discontinued lyophilized powder formulation of Eloxatin (Oxaliplatin for injection) in 50 mg and 100 mg vials is suitable for submission as an Abbreviated New Drug Appl | Other | 2008-08-12 | Granted | AAC Consulting Group |
Rothwell, Figg, Ernst & Manbeck, P.C. - Citizen Petition FDA-2006-P-0201 · 6 docket documents Rothwell, Figg, Ernst & Manbeck, P.C. filed this petition requesting that the FDA determine whether Eloxatin (Oxaliplatin for Injection) 50 mg and 100 mg sterile lyophilized powder vials, approved under NDA 21-492 by Sanofi Aventis US, was voluntarily withdrawn from sale for safety or effectiveness | 505(q) | 2008-06-19 | Granted | — |
Citizen Petition from Regulus Pharmaceutical Consulting, Inc. FDA-2007-P-0247 · 7 docket documents Regulus Pharmaceutical Consulting, Inc. filed this petition requesting that the FDA determine whether Eloxatin (oxaliplatin for injection) lyophilized powder, 50 and 100 mg vials, approved under NDA 21-492 and held by Sanofi-Aventis US, was withdrawn from sale for safety or effectiveness reasons, an | 505(q) | 2008-05-15 | Open | Regulus Pharmaceutical Consulting, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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