APPLICATION
ANDA064212
TYPE
ANDA
ORIGINAL APPROVAL
1998-06-23
LATEST ACTION
2001-12-10
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
DAUNORUBICIN HYDROCHLORIDEDiscontinued
DAUNORUBICIN HYDROCHLORIDE EQ 20MG BASE/VIAL · INJECTABLE · INJECTION
DAUNORUBICIN HYDROCHLORIDEDiscontinued
DAUNORUBICIN HYDROCHLORIDE EQ 50MG BASE/VIAL · INJECTABLE · INJECTION
Approval history
2001-12-10Labeling · Supplement 5AP
1999-05-03Labeling · Supplement 4AP
1999-05-03Manufacturing (CMC) · Supplement 2AP
1999-05-03Manufacturing (CMC) · Supplement 3AP
1999-05-03Manufacturing (CMC) · Supplement 1AP
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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