← FDA DRUG APPROVALS

FDA NDA · NDA050661

IDAMYCIN

Sponsor: PFIZER

APPLICATION
NDA050661
TYPE
NDA
ORIGINAL APPROVAL
1990-09-27
LATEST ACTION
2022-04-27
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Discontinued

Products

IDAMYCINDiscontinued
IDARUBICIN HYDROCHLORIDE 5MG/VIAL · POWDER · INTRAVENOUS
IDAMYCINDiscontinued
IDARUBICIN HYDROCHLORIDE 20MG/VIAL · POWDER · INTRAVENOUS
IDAMYCINDiscontinued
IDARUBICIN HYDROCHLORIDE 10MG/VIAL · POWDER · INTRAVENOUS

Approval history

2022-04-27Labeling · Supplement 17 · standard — Letter ↗AP
2021-02-10Labeling · Supplement 16 · standard — Letter ↗AP
2019-08-02Labeling · Supplement 15 · standard — Label ↗AP
2014-12-04Labeling · Supplement 14 · standard — Label ↗AP
2002-10-11Labeling · Supplement 8 · standard — Letter ↗AP
2002-09-30Labeling · Supplement 7 · standard — Letter ↗AP
2002-04-02Manufacturing (CMC) · Supplement 11 · priorityAP
2000-11-21Manufacturing (CMC) · Supplement 10 · priorityAP
2000-04-07Manufacturing (CMC) · Supplement 9 · priorityAP
1998-04-22Manufacturing (CMC) · Supplement 6 · priorityAP
1997-09-11Manufacturing (CMC) · Supplement 5 · priorityAP
1996-09-17Manufacturing (CMC) · Supplement 4 · priorityAP
1995-04-25Manufacturing (CMC) · Supplement 3 · priorityAP
1993-06-29Manufacturing (CMC) · Supplement 2 · priorityAP
1991-01-07Labeling · Supplement 1AP
1990-09-27Type 1 - New Molecular Entity · Original · priorityAP
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 →