Oxaliplatin

Treats stage III colon cancer. ANDA 207325, held by Gland. Oxaliplatin.

As of Nov 14, 2026, ANDA 207325 (Oxaliplatin), held by Gland, was first approved by FDA on Feb 10, 2017, with 2 approved supplements and 0 published complete response letters.

First approved: Feb 10, 2017
Review: Standard
Supplements approved: 2
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 3 submissions below

Date	Submission	Status	Documents
Feb 10, 2017	Original application	Approved	None posted

Products

3 strengths and forms


Oxaliplatin50MG/10ML (5MG/ML) · injectable;intravenous	Oxaliplatin	Rx
Oxaliplatin100MG/20ML (5MG/ML) · injectable;intravenous	Oxaliplatin	Rx
Oxaliplatin200MG/40ML (5MG/ML) · injectable;intravenous	Oxaliplatin	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Dec 11, 2023	Supplement 9Labeling · Standard review	Approved	None posted
Dec 15, 2021	Supplement 4Labeling · Standard review	Approved	None posted
Feb 10, 2017	Original application	Approved	None posted

Identifiers

Application: ANDA 207325
Drugs@FDA: Overview at FDA
Company: Gland Pharma

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