Eloxatin

NDA 21759, held by Sanofi Aventis US. Oxaliplatin.

As of Nov 14, 2026, NDA 21759 (Eloxatin), held by Sanofi Aventis US, was first approved by FDA on Jan 31, 2005, with 14 approved supplements and 0 published complete response letters.

First approved: Jan 31, 2005
Review: Standard
Supplements approved: 14
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
Jan 31, 2005	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Letter Label

Products

3 strengths and forms


Eloxatin50MG/10ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;intravenous	Oxaliplatin	DiscontinuedReference drug
Eloxatin100MG/20ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;intravenous	Oxaliplatin	DiscontinuedReference drug
Eloxatin200MG/40ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;intravenous	Oxaliplatin	DiscontinuedReference drug

All 15 submissions, including labeling and manufacturing supplements


Jun 23, 2023	Supplement 24Labeling · Standard review	Approved	Label Letter
Apr 6, 2020	Supplement 23Labeling · Standard review	Approved	Label Letter
Dec 9, 2016	Supplement 21Manufacturing · Standard review	Approved	None posted
Oct 1, 2015	Supplement 19Labeling · Standard review	Approved	Label Letter
Jan 20, 2015	Supplement 18Manufacturing · Standard review	Approved	None posted
Nov 15, 2013	Supplement 17Manufacturing · Standard review	Approved	None posted
Jul 16, 2013	Supplement 16Labeling · Standard review	Approved	Letter Label
Oct 12, 2012	Supplement 15Labeling · Standard review	Approved	Letter Label
Dec 28, 2011	Supplement 12Labeling	Approved	Letter Label
Jul 22, 2009	Supplement 10Manufacturing	Approved	None posted
Mar 13, 2009	Supplement 9Labeling · Standard review	Approved	Label Letter
May 21, 2008	Supplement 8Labeling · Standard review	Approved	Letter
Nov 17, 2006	Supplement 6Manufacturing	Approved	None posted
Mar 9, 2006	Supplement 1Labeling · Standard review	Approved	Letter Label
Jan 31, 2005	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21759
Drugs@FDA: Overview at FDA
Company: sanofi-aventis US

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