Oxaliplatin

Treats stage III colon cancer. ANDA 204368, held by Qilu Pharm Hainan. Oxaliplatin.

As of Nov 14, 2026, ANDA 204368 (Oxaliplatin), held by Qilu Pharm Hainan, was first approved by FDA on Jun 7, 2016, with 3 approved supplements and 0 published complete response letters.

First approved: Jun 7, 2016
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Oxaliplatin Injection USP, 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 4 submissions below

Date	Submission	Status	Documents
Jun 7, 2016	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	Rx

All 4 submissions, including labeling and manufacturing supplements


Dec 11, 2023	Supplement 16Labeling · Standard review	Approved	None posted
Nov 17, 2021	Supplement 3Labeling · Standard review	Approved	None posted
Nov 17, 2021	Supplement 5Labeling · Standard review	Approved	None posted
Jun 7, 2016	Original application	Approved	None posted

Identifiers

Application: ANDA 204368
Drugs@FDA: Overview at FDA
Company: Qilu Pharmaceutical (Hainan)

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