Oxaliplatin

ANDA 78812, held by Sandoz. Oxaliplatin.

As of Nov 14, 2026, ANDA 78812 (Oxaliplatin), held by Sandoz, 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

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	None posted

Products

2 strengths and forms


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

All 4 submissions, including labeling and manufacturing supplements


Sep 10, 2015	Supplement 3Labeling · Standard review	Approved	None posted
Sep 10, 2015	Supplement 6Labeling · Standard review	Approved	None posted
Feb 28, 2013	Supplement 2Labeling · Standard review	Approved	None posted
Aug 7, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 78812
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