Zinecard

NDA 20212, held by Pfizer. Dexrazoxane Hydrochloride.

As of Nov 13, 2026, NDA 20212 (Zinecard), held by Pfizer, was first approved by FDA on May 26, 1995, with 11 approved supplements and 0 published complete response letters.

First approved: May 26, 1995
Review: Priority
Supplements approved: 11
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below


Oct 31, 2002	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Letter Label
May 26, 1995	Original applicationNew molecular entity · Priority review	Approved	Review

Products

2 strengths and forms


ZinecardEQ 250MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Dexrazoxane Hydrochloride	DiscontinuedReference drug
ZinecardEQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Dexrazoxane Hydrochloride	DiscontinuedReference drug

All 12 submissions, including labeling and manufacturing supplements


May 12, 2025	Supplement 21Labeling · Standard review	Approved	Letter Label
Jan 6, 2016	Supplement 18Manufacturing · Priority review	Approved	None posted
Apr 18, 2014	Supplement 17Labeling · Standard review	Approved	Label Letter
Oct 3, 2013	Supplement 16Manufacturing · Priority review	Approved	None posted
Apr 11, 2013	Supplement 15Manufacturing · Priority review	Approved	None posted
Jul 3, 2012	Supplement 13Labeling · Standard review	Approved	Label Letter
May 20, 2005	Supplement 8Labeling · Standard review	Approved	Letter Label
Oct 31, 2002	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Letter Label
Oct 31, 2002	Supplement 5Labeling · Priority review	Approved	Label Letter
Oct 31, 2002	Supplement 4Labeling · Priority review	Approved	Letter Label
May 8, 2001	Supplement 3Manufacturing · Priority review	Approved	None posted
May 26, 1995	Original applicationNew molecular entity · Priority review	Approved	Review

Identifiers

Application: NDA 20212
Drugs@FDA: Overview at FDA
Company: Pfizer

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