APPLICATION
ANDA063097
TYPE
ANDA
ORIGINAL APPROVAL
1990-05-21
LATEST ACTION
2003-08-14
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
DOXORUBICIN HYDROCHLORIDEDiscontinued
DOXORUBICIN HYDROCHLORIDE 50MG/VIAL · INJECTABLE · INJECTION
DOXORUBICIN HYDROCHLORIDEDiscontinued
DOXORUBICIN HYDROCHLORIDE 10MG/VIAL · INJECTABLE · INJECTION
DOXORUBICIN HYDROCHLORIDEDiscontinued
DOXORUBICIN HYDROCHLORIDE 20MG/VIAL · INJECTABLE · INJECTION
Approval history
2003-08-14Labeling · Supplement 21AP
2002-09-19Manufacturing (CMC) · Supplement 18AP
2002-09-18Labeling · Supplement 19AP
2001-02-15Manufacturing (CMC) · Supplement 15AP
2000-08-25Labeling · Supplement 16AP
2000-08-25Labeling · Supplement 17AP
2000-03-30Manufacturing (CMC) · Supplement 14AP
1999-07-13Labeling · Supplement 13AP
1996-04-03Labeling · Supplement 26AP
1996-04-03Labeling · Supplement 11AP
1996-01-29Manufacturing (CMC) · Supplement 8AP
1996-01-29Manufacturing (CMC) · Supplement 6AP
1996-01-29Labeling · Supplement 10AP
1996-01-29Manufacturing (CMC) · Supplement 9AP
1996-01-29Manufacturing (CMC) · Supplement 7AP
1995-06-07Manufacturing (CMC) · Supplement 12AP
1994-07-26Manufacturing (CMC) · Supplement 5AP
1992-03-31Labeling · Supplement 2AP
1992-03-31Manufacturing (CMC) · Supplement 3AP
1990-05-21OriginalAP
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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