Deferoxamine Mesylate

ANDA 78086, held by Hikma. Deferoxamine Mesylate.

As of Nov 15, 2026, ANDA 78086 (Deferoxamine Mesylate), held by Hikma, was first approved by FDA on May 30, 2007, with 2 approved supplements and 0 published complete response letters.

First approved: May 30, 2007
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
May 30, 2007	Original application	Approved	None posted

Products

2 strengths and forms


Deferoxamine Mesylate500MG/VIAL · injectable;injection	Deferoxamine Mesylate	Discontinued
Deferoxamine Mesylate2GM/VIAL · injectable;injection	Deferoxamine Mesylate	Discontinued

All 3 submissions, including labeling and manufacturing supplements


May 26, 2011	Supplement 5Labeling	Approved	None posted
Dec 3, 2009	Supplement 1Labeling	Approved	None posted
May 30, 2007	Original application	Approved	None posted

Identifiers

Application: ANDA 78086
Drugs@FDA: Overview at FDA
Company: Hikma

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