APPLICATION
ANDA062921
TYPE
ANDA
ORIGINAL APPROVAL
1989-03-17
LATEST ACTION
2018-01-19
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
DOXORUBICIN HYDROCHLORIDEPrescription
DOXORUBICIN HYDROCHLORIDE 50MG/VIAL · INJECTABLE · INJECTION
DOXORUBICIN HYDROCHLORIDEPrescription
DOXORUBICIN HYDROCHLORIDE 10MG/VIAL · INJECTABLE · INJECTION
DOXORUBICIN HYDROCHLORIDEPrescription
DOXORUBICIN HYDROCHLORIDE 20MG/VIAL · INJECTABLE · INJECTION
Approval history
2018-01-19Manufacturing (CMC) · Supplement 26AP
2010-11-18Labeling · Supplement 20AP
2007-02-15Labeling · Supplement 18AP
2003-07-28Labeling · Supplement 15AP
2000-09-19Labeling · Supplement 14AP
1999-08-24Labeling · Supplement 13AP
1998-12-01Labeling · Supplement 12AP
1997-04-30Labeling · Supplement 11AP
1996-10-31Manufacturing (CMC) · Supplement 5AP
1996-07-29Labeling · Supplement 10AP
1995-02-24Labeling · Supplement 8AP
1995-02-24Manufacturing (CMC) · Supplement 9AP
1993-11-16Manufacturing (CMC) · Supplement 7AP
1993-07-28Labeling · Supplement 6AP
1993-05-27Manufacturing (CMC) · Supplement 4AP
1992-06-08Manufacturing (CMC) · Supplement 3AP
1992-02-03Manufacturing (CMC) · Supplement 2AP
1989-10-05Manufacturing (CMC) · Supplement 1AP
1989-03-17OriginalAP
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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