NDA 21492, held by Sanofi Aventis US. Oxaliplatin.
As of Nov 14, 2026, NDA 21492 (Eloxatin), held by Sanofi Aventis US, was first approved by FDA on Aug 9, 2002, with 12 approved supplements and 0 published complete response letters.
| May 21, 2008 | Supplement 10Efficacy (new indication or use) · Standard review | Approved | |
| Jan 10, 2007 | Supplement 8Efficacy (new indication or use) · Priority review | Approved | |
| Nov 4, 2004 | Supplement 4Efficacy (new indication or use) | Approved | |
| Jan 9, 2004 | Supplement 2Efficacy (new indication or use) · Priority review | Approved | |
| Aug 9, 2002 | Original applicationNew molecular entity · Priority review | Approved |
| Eloxatin50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;intravenous | Oxaliplatin | DiscontinuedReference drug |
| Eloxatin100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;intravenous | Oxaliplatin | DiscontinuedReference drug |
| Apr 6, 2020 | Supplement 16Labeling · Standard review | Approved | |
| Oct 1, 2015 | Supplement 14Labeling · Standard review | Approved | |
| Oct 12, 2012 | Supplement 13Labeling · Standard review | Approved | |
| Dec 28, 2011 | Supplement 12Labeling | Approved | |
| Mar 13, 2009 | Supplement 11Labeling · Standard review | Approved | |
| May 21, 2008 | Supplement 10Efficacy (new indication or use) · Standard review | Approved | |
| Jan 10, 2007 | Supplement 8Efficacy (new indication or use) · Priority review | Approved | |
| Mar 9, 2006 | Supplement 6Labeling · Standard review | Approved | |
| Nov 4, 2004 | Supplement 4Efficacy (new indication or use) | Approved | |
| Nov 4, 2004 | Supplement 5Labeling · Standard review | Approved | |
| Jan 9, 2004 | Supplement 2Efficacy (new indication or use) · Priority review | Approved | |
| Jan 14, 2003 | Supplement 1Labeling · Standard review | Approved | |
| Aug 9, 2002 | Original applicationNew molecular entity · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
