APPLICATION
ANDA064097
TYPE
ANDA
ORIGINAL APPROVAL
1994-09-13
LATEST ACTION
2012-07-25
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
DOXORUBICIN HYDROCHLORIDEPrescription
DOXORUBICIN HYDROCHLORIDE 200MG/100ML · INJECTABLE · INJECTION
Approval history
2010-11-18Labeling · Supplement 15AP
2007-02-14Labeling · Supplement 14AP
2003-07-28Labeling · Supplement 9AP
2000-09-19Labeling · Supplement 7AP
1999-08-24Labeling · Supplement 6AP
1998-12-01Labeling · Supplement 5AP
1997-05-23Manufacturing (CMC) · Supplement 2AP
1997-04-30Labeling · Supplement 4AP
1996-07-29Labeling · Supplement 1AP
1994-09-13OriginalAP
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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