Oxaliplatin

ANDA 208523, held by Chartwell Molecular. Oxaliplatin.

As of Nov 14, 2026, ANDA 208523 (Oxaliplatin), held by Chartwell Molecular, was first approved by FDA on Feb 10, 2017, with 1 approved supplement and 0 published complete response letters.

First approved: Feb 10, 2017
Review: Standard
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

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

Products

2 strengths and forms


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

All 2 submissions, including labeling and manufacturing supplements


Mar 3, 2021	Supplement 1Labeling · Standard review	Approved	None posted
Feb 10, 2017	Original application	Approved	None posted

Identifiers

Application: ANDA 208523
Drugs@FDA: Overview at FDA
Company: Chartwell Molecular

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