APPLICATION
ANDA063336
TYPE
ANDA
ORIGINAL APPROVAL
1995-02-28
LATEST ACTION
2002-09-19
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
DOXORUBICIN HYDROCHLORIDEDiscontinued
DOXORUBICIN HYDROCHLORIDE 2MG/ML · INJECTABLE · INJECTION
DOXORUBICIN HYDROCHLORIDEDiscontinued
DOXORUBICIN HYDROCHLORIDE 200MG/100ML · INJECTABLE · INJECTION
Approval history
2002-09-19Manufacturing (CMC) · Supplement 7AP
2000-08-25Labeling · Supplement 5AP
2000-08-25Labeling · Supplement 6AP
2000-03-30Manufacturing (CMC) · Supplement 4AP
1999-07-13Labeling · Supplement 3AP
1996-04-03Labeling · Supplement 2AP
1995-11-01Manufacturing (CMC) · Supplement 1AP
1995-02-28OriginalAP
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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