APPLICATION
NDA018768
TYPE
NDA
ORIGINAL APPROVAL
1983-11-10
LATEST ACTION
2002-11-05
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
VEPESID · ReferenceDiscontinued
ETOPOSIDE 20MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
2000-10-25Manufacturing (CMC) · Supplement 46 · priorityAP
2000-02-02Manufacturing (CMC) · Supplement 44 · priorityAP
1998-12-15Manufacturing (CMC) · Supplement 40 · priorityAP
1995-12-11Manufacturing (CMC) · Supplement 37 · priorityAP
1995-08-08Manufacturing (CMC) · Supplement 36 · priorityAP
1995-06-27Manufacturing (CMC) · Supplement 35 · priorityAP
1995-05-17Manufacturing (CMC) · Supplement 27 · priorityAP
1993-12-20Manufacturing (CMC) · Supplement 31 · priorityAP
1993-08-30Manufacturing (CMC) · Supplement 32 · priorityAP
1993-08-24Manufacturing (CMC) · Supplement 28 · priorityAP
1993-07-23Labeling · Supplement 30 · standardAP
1991-11-01Labeling · Supplement 26AP
1991-11-01Labeling · Supplement 25AP
1990-09-04Manufacturing (CMC) · Supplement 24 · priorityAP
1990-04-04Manufacturing (CMC) · Supplement 23 · priorityAP
1989-04-10Manufacturing (CMC) · Supplement 22 · priorityAP
1988-04-28Manufacturing (CMC) · Supplement 15 · priorityAP
1988-02-11Manufacturing (CMC) · Supplement 18 · priorityAP
1988-01-25Labeling · Supplement 17AP
1987-05-20Labeling · Supplement 16AP
1987-03-19Manufacturing (CMC) · Supplement 14 · priorityAP
1986-12-22Labeling · Supplement 13AP
1986-11-06Manufacturing (CMC) · Supplement 9 · priorityAP
1986-10-29Manufacturing (CMC) · Supplement 12 · priorityAP
1986-09-04Efficacy · Supplement 7AP
1986-08-26Labeling · Supplement 10AP
1986-06-30Manufacturing (CMC) · Supplement 11 · priorityAP
1985-03-12Manufacturing (CMC) · Supplement 6 · priorityAP
1985-03-06Labeling · Supplement 5AP
1985-03-06Labeling · Supplement 3AP
1985-03-06Labeling · Supplement 4AP
1985-03-06Labeling · Supplement 2AP
1984-08-21Manufacturing (CMC) · Supplement 1 · priorityAP
1983-11-10Type 1 - New Molecular Entity · Original · priorityAP
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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