← FDA DRUG APPROVALS

FDA ANDA · ANDA074227

ETOPOSIDE

Sponsor: PHARMACHEMIE BV

APPLICATION
ANDA074227
TYPE
ANDA
ORIGINAL APPROVAL
1996-02-22
LATEST ACTION
2002-07-16
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

ETOPOSIDEDiscontinued
ETOPOSIDE 20MG/ML · INJECTABLE · INJECTION

Approval history

2002-07-16Manufacturing (CMC) · Supplement 4AP
1998-05-13Manufacturing (CMC) · Supplement 1AP
1998-05-13Manufacturing (CMC) · Supplement 2AP
1996-02-22OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →