Deferoxamine Mesylate

Treats acute iron intoxication. ANDA 76019, held by Hospira. Deferoxamine Mesylate.

As of Nov 15, 2026, ANDA 76019 (Deferoxamine Mesylate), held by Hospira, was first approved by FDA on Mar 17, 2004, with 7 approved supplements and 0 published complete response letters.

First approved: Mar 17, 2004
Supplements approved: 7
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Deferoxamine mesylate for injection is an iron-chelating agent indicated:

As an adjunct to standard measures for the treatment of acute iron intoxication.
For the treatment of transfusional iron overload in patients with chronic anemia. Limitations of Use Deferoxamine mesylate for injection is not indicated for the treatment of primary hemochromatosis (since phlebotomy is the method of choice for removing excess iron in this disorder). 1.1 Acute Iron Intoxication Deferoxamine Mesylate for injection is indicated as an adjunct to standard measures for the treatment of acute iron intoxication. 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Mar 17, 2004	Original application	Approved	Review Letter

Products

2 strengths and forms


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

All 8 submissions, including labeling and manufacturing supplements


Nov 9, 2026	Supplement 33Labeling · Standard review	Approved	None posted
May 8, 2025	Supplement 30Labeling · Standard review	Approved	None posted
Oct 23, 2023	Supplement 20Labeling · Standard review	Approved	None posted
Oct 23, 2023	Supplement 27Labeling · Standard review	Approved	None posted
Nov 8, 2016	Supplement 14Labeling · Standard review	Approved	None posted
Dec 3, 2009	Supplement 11Labeling	Approved	None posted
Dec 14, 2007	Supplement 8Labeling	Approved	None posted
Mar 17, 2004	Original application	Approved	Review Letter

Identifiers

Application: ANDA 76019
Drugs@FDA: Overview at FDA
Company: Hospira

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