APPLICATION
ANDA063277
TYPE
ANDA
ORIGINAL APPROVAL
1995-10-26
LATEST ACTION
2025-06-03
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
DOXORUBICIN HYDROCHLORIDEPrescription
DOXORUBICIN HYDROCHLORIDE 2MG/ML · INJECTABLE · INJECTION
Approval history
2025-06-03Labeling · Supplement 31 · standardAP
2025-06-03Labeling · Supplement 32 · standardAP
2025-06-03Labeling · Supplement 24 · standardAP
2014-11-05Labeling · Supplement 20 · standardAP
2007-05-14Labeling · Supplement 14AP
2002-12-05Manufacturing (CMC) · Supplement 12AP
2000-07-20Manufacturing (CMC) · Supplement 10AP
2000-07-20Manufacturing (CMC) · Supplement 9AP
2000-07-20Manufacturing (CMC) · Supplement 8AP
1999-01-28Labeling · Supplement 7AP
1997-01-10Manufacturing (CMC) · Supplement 4AP
1997-01-10Manufacturing (CMC) · Supplement 2AP
1997-01-10Labeling · Supplement 5AP
1997-01-10Manufacturing (CMC) · Supplement 3AP
1997-01-10Manufacturing (CMC) · Supplement 1AP
1996-11-29Labeling · Supplement 6AP
1995-10-26OriginalAP
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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