← FDA DRUG APPROVALS

FDA NDA · NDA020212

ZINECARD

Sponsor: PFIZER

APPLICATION
NDA020212
TYPE
NDA
ORIGINAL APPROVAL
1995-05-26
LATEST ACTION
2025-05-12
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

ZINECARD · ReferenceDiscontinued
DEXRAZOXANE HYDROCHLORIDE EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
ZINECARD · ReferenceDiscontinued
DEXRAZOXANE HYDROCHLORIDE EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION

Approval history

2025-05-12Labeling · Supplement 21 · standard — Letter ↗AP
2016-01-06Manufacturing (CMC) · Supplement 18 · priorityAP
2014-04-18Labeling · Supplement 17 · standard — Label ↗AP
2013-10-03Manufacturing (CMC) · Supplement 16 · priorityAP
2013-04-11Manufacturing (CMC) · Supplement 15 · priorityAP
2012-07-03Labeling · Supplement 13 · standard — Letter ↗AP
2005-05-20Labeling · Supplement 8 · standard — Letter ↗AP
2002-10-31Labeling · Supplement 5 · priority — Label ↗AP
2002-10-31Efficacy · Supplement 6 · standard — Letter ↗AP
2002-10-31Labeling · Supplement 4 · priority — Letter ↗AP
2001-05-08Manufacturing (CMC) · Supplement 3 · priorityAP
1995-05-26Type 1 - New Molecular Entity · Original · priority — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →