Oxaliplatin

Treats stage III colon cancer. ANDA 78813, held by Hospira Worldwide. Oxaliplatin.

As of Nov 14, 2026, ANDA 78813 (Oxaliplatin), held by Hospira Worldwide, was first approved by FDA on Aug 7, 2009, with 3 approved supplements and 0 published complete response letters.

First approved: Aug 7, 2009
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Oxaliplatin, in combination with infusional fluorouracil and leucovorin, is indicated for:

adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor.
treatment of advanced colorectal cancer. Oxaliplatin is a platinum-based drug used in combination with infusional fluorouracil and leucovorin, which is

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Aug 7, 2009	Original application	Approved	Review

Products

2 strengths and forms


Oxaliplatin50MG/10ML (5MG/ML) · injectable;intravenous	Oxaliplatin	Rx
Oxaliplatin100MG/20ML (5MG/ML) · injectable;intravenous	Oxaliplatin	Rx

All 4 submissions, including labeling and manufacturing supplements


Dec 11, 2023	Supplement 15Labeling · Standard review	Approved	None posted
Nov 18, 2021	Supplement 10Labeling · Standard review	Approved	None posted
Jun 24, 2016	Supplement 8Labeling · Standard review	Approved	None posted
Aug 7, 2009	Original application	Approved	Review

Identifiers

Application: ANDA 78813
Drugs@FDA: Overview at FDA
Company: Hospira Worldwide

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