APPLICATION
NDA050484
TYPE
NDA
ORIGINAL APPROVAL
1979-12-19
LATEST ACTION
1994-09-01
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
CERUBIDINEDiscontinued
DAUNORUBICIN HYDROCHLORIDE EQ 20MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
1994-09-01Manufacturing (CMC) · Supplement 6 · priorityAP
1993-04-22Labeling · Supplement 5 · priorityAP
1992-03-11Labeling · Supplement 4 · priorityAP
1987-03-06Efficacy · Supplement 3 · priorityAP
1982-12-03Labeling · Supplement 2 · priorityAP
1980-02-26Labeling · Supplement 1 · priorityAP
1979-12-19Type 1 - New Molecular Entity · Original · priorityAP
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.
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