APPLICATION
ANDA074351
TYPE
ANDA
ORIGINAL APPROVAL
1995-08-30
LATEST ACTION
2002-04-10
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
ETOPOSIDEDiscontinued
ETOPOSIDE 20MG/ML · INJECTABLE · INJECTION
Approval history
2002-04-10Manufacturing (CMC) · Supplement 2AP
2002-03-12Manufacturing (CMC) · Supplement 3AP
1999-07-28Manufacturing (CMC) · Supplement 1AP
1995-08-30OriginalAP
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.