Oxaliplatin

Treats stage III colon cancer. ANDA 78817, held by Sandoz. Oxaliplatin.

As of Nov 14, 2026, ANDA 78817 (Oxaliplatin), held by Sandoz, was first approved by FDA on Jan 24, 2011, with 6 approved supplements and 0 published complete response letters.

First approved: Jan 24, 2011
Supplements approved: 6
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Oxaliplatin injection, 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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below


Jan 24, 2011	Original application	Approved	Review
Jan 24, 2011	Original application	Tentative approval	None posted

Products

2 strengths and forms


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

All 8 submissions, including labeling and manufacturing supplements


Nov 28, 2023	Supplement 27Labeling · Standard review	Approved	None posted
Nov 18, 2021	Supplement 25Labeling · Standard review	Approved	None posted
Dec 11, 2015	Supplement 7Labeling · Standard review	Approved	None posted
Dec 11, 2015	Supplement 8Labeling · Standard review	Approved	None posted
Dec 11, 2015	Supplement 16Labeling · Standard review	Approved	None posted
Feb 27, 2013	Supplement 1Labeling	Approved	None posted
Jan 24, 2011	Original application	Approved	Review
Jan 24, 2011	Original application	Tentative approval	None posted

Identifiers

Application: ANDA 78817
Drugs@FDA: Overview at FDA
Company: Sandoz

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