OXALIPLATIN | N022160 | TEVA PHARMACEUTICALS USA
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Lachman Consultant Services, Inc. - Citizen Petition FDA-2010-P-0581 · 5 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 Oxaliplatin Injection 5 mg/mL, subject of NDA 022160 held by Teva, as a second reference-listed drug in the Orange Book so that ANDA applicants coul | Other | 2011-01-25 | Granted | — |
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whether Eloxatin (Oxaliplatin for Injection), 50 mg and 100 mg per vial, approved under NDA 21-492, was voluntarily withdrawn or withheld from sale for reasons of saf | 505(q) | 2008-08-21 | Withdrawn | — |
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50 mg and 100 mg sterile lyophilized powder vials, approved under NDA 21-492 by Sanofi Aventis US, was voluntarily withdrawn from sale for safety or effectiveness | 505(q) | 2008-06-19 | Granted | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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