APPLICATION
ANDA074290
TYPE
ANDA
ORIGINAL APPROVAL
1995-07-17
LATEST ACTION
2013-01-08
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
ETOPOSIDEPrescription
ETOPOSIDE 20MG/ML · INJECTABLE · INJECTION
Approval history
2013-01-08Labeling · Supplement 20 · standardAP
2001-12-18Manufacturing (CMC) · Supplement 11AP
2001-06-05Manufacturing (CMC) · Supplement 7AP
2001-06-05Manufacturing (CMC) · Supplement 8AP
2001-04-03Manufacturing (CMC) · Supplement 10AP
2000-09-19Labeling · Supplement 9AP
2000-08-03Manufacturing (CMC) · Supplement 6AP
1998-10-26Manufacturing (CMC) · Supplement 5AP
1996-11-20Manufacturing (CMC) · Supplement 3AP
1996-11-20Manufacturing (CMC) · Supplement 1AP
1996-11-20Manufacturing (CMC) · Supplement 4AP
1995-07-17OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.