APPLICATION
ANDA064140
TYPE
ANDA
ORIGINAL APPROVAL
1995-07-28
LATEST ACTION
2014-12-12
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
DOXORUBICIN HYDROCHLORIDEDiscontinued
DOXORUBICIN HYDROCHLORIDE 200MG/100ML · INJECTABLE · INJECTION
DOXORUBICIN HYDROCHLORIDEDiscontinued
DOXORUBICIN HYDROCHLORIDE 2MG/ML · INJECTABLE · INJECTION
Approval history
2014-12-12Labeling · Supplement 35 · standardAP
2013-06-24Labeling · Supplement 27AP
2001-05-08Manufacturing (CMC) · Supplement 7AP
2000-06-08Manufacturing (CMC) · Supplement 5AP
2000-06-08Manufacturing (CMC) · Supplement 3AP
2000-06-08Labeling · Supplement 4AP
1999-10-06Labeling · Supplement 6AP
1996-11-29Labeling · Supplement 2AP
1996-07-24Labeling · Supplement 1AP
1995-07-28OriginalAP
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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