Oxaliplatin

ANDA 78818, held by Sun Pharm. Oxaliplatin.

As of Nov 14, 2026, ANDA 78818 (Oxaliplatin), held by Sun Pharm, was first approved by FDA on Aug 7, 2009, with 1 approved supplement and 0 published complete response letters.

First approved: Aug 7, 2009
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
Aug 7, 2009	Original application	Approved	None posted

Products

2 strengths and forms


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

All 2 submissions, including labeling and manufacturing supplements


Mar 20, 2013	Supplement 2Labeling · Standard review	Approved	Letter Label
Aug 7, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 78818
Drugs@FDA: Overview at FDA
Company: Sun 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