APPLICATION
ANDA062926
TYPE
ANDA
ORIGINAL APPROVAL
1989-04-13
LATEST ACTION
2001-05-24
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
RUBEXDiscontinued
DOXORUBICIN HYDROCHLORIDE 50MG/VIAL · INJECTABLE · INJECTION
RUBEXDiscontinued
DOXORUBICIN HYDROCHLORIDE 100MG/VIAL · INJECTABLE · INJECTION
RUBEXDiscontinued
DOXORUBICIN HYDROCHLORIDE 10MG/VIAL · INJECTABLE · INJECTION
Approval history
2001-05-24Labeling · Supplement 7AP
2000-11-02Manufacturing (CMC) · Supplement 8AP
2000-05-11Manufacturing (CMC) · Supplement 5AP
1999-08-24Labeling · Supplement 4AP
1998-12-01Labeling · Supplement 3AP
1997-07-11Labeling · Supplement 2AP
1996-07-24Labeling · Supplement 1AP
1989-04-13OriginalAP
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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