APPLICATION
ANDA074529
TYPE
ANDA
ORIGINAL APPROVAL
1996-07-24
LATEST ACTION
2012-01-31
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
ETOPOSIDEPrescription
ETOPOSIDE 20MG/ML · INJECTABLE · INJECTION
Approval history
2012-01-31Labeling · Supplement 43AP
2002-08-29Manufacturing (CMC) · Supplement 13AP
2002-04-11Labeling · Supplement 14AP
2001-03-14Labeling · Supplement 12AP
2000-08-09Labeling · Supplement 11AP
1999-11-19Labeling · Supplement 10AP
1999-11-19Manufacturing (CMC) · Supplement 9AP
1997-05-09Manufacturing (CMC) · Supplement 5AP
1997-05-09Manufacturing (CMC) · Supplement 3AP
1997-05-09Labeling · Supplement 1AP
1997-05-09Manufacturing (CMC) · Supplement 4AP
1997-05-09Manufacturing (CMC) · Supplement 2AP
1996-12-12Manufacturing (CMC) · Supplement 7AP
1996-12-12Manufacturing (CMC) · Supplement 8AP
1996-12-12Manufacturing (CMC) · Supplement 6AP
1996-07-24OriginalAP
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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