Dexrazoxane Hydrochloride

For metastatic breast cancer. ANDA 200752, held by Eugia Pharma. Dexrazoxane Hydrochloride.

As of Nov 15, 2026, ANDA 200752 (Dexrazoxane Hydrochloride), held by Eugia Pharma, was first approved by FDA on Oct 19, 2011, with 2 approved supplements and 0 published complete response letters.

First approved: Oct 19, 2011
Supplements approved: 2
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Dexrazoxane for injection is indicated for reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration in women with metastatic breast cancer who have received a cumulative doxorubicin dose of 300 mg/m 2 and who will continue to receive doxorubicin therapy to maintain tumor control. Do not use with the initiation of doxorubicin therapy.

Full prescribing information on DailyMed ↗

Approvals and New Uses

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

Date	Submission	Status	Documents
Oct 19, 2011	Original application	Approved	None posted

Products

2 strengths and forms


Dexrazoxane HydrochlorideEQ 250MG BASE/VIAL · injectable;injection	Dexrazoxane Hydrochloride	Rx
Dexrazoxane HydrochlorideEQ 500MG BASE/VIAL · injectable;injection	Dexrazoxane Hydrochloride	Rx

All 3 submissions, including labeling and manufacturing supplements


May 19, 2015	Supplement 2Labeling · Standard review	Approved	None posted
May 19, 2015	Supplement 4Labeling · Standard review	Approved	None posted
Oct 19, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 200752
Drugs@FDA: Overview at FDA
Company: Eugia 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