Oxaliplatin

ANDA 78803, held by Actavis Totowa. Oxaliplatin.

As of Nov 14, 2026, ANDA 78803 (Oxaliplatin), held by Actavis Totowa, was first approved by FDA on Aug 8, 2012, with 4 approved supplements and 0 published complete response letters.

First approved: Aug 8, 2012
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Aug 8, 2012	Original application	Approved	None posted

Products

2 strengths and forms


Oxaliplatin50MG/VIAL · injectable;intravenous	Oxaliplatin	Discontinued
Oxaliplatin100MG/VIAL · injectable;intravenous	Oxaliplatin	Discontinued

All 5 submissions, including labeling and manufacturing supplements


Nov 29, 2023	Supplement 7Labeling · Standard review	Approved	None posted
Dec 31, 2015	Supplement 4Labeling · Standard review	Approved	None posted
Dec 31, 2015	Supplement 3Labeling · Standard review	Approved	None posted
Mar 20, 2013	Supplement 2Labeling · Standard review	Approved	None posted
Aug 8, 2012	Original application	Approved	None posted

Identifiers

Application: ANDA 78803
Drugs@FDA: Overview at FDA
Company: Actavis Totowa

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