← FDA DRUG APPROVALS

FDA ANDA · ANDA078818

OXALIPLATIN

Sponsor: SUN PHARM

APPLICATION
ANDA078818
TYPE
ANDA
ORIGINAL APPROVAL
2009-08-07
LATEST ACTION
2013-03-20
ROUTE
INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

OXALIPLATINDiscontinued
OXALIPLATIN 100MG/VIAL · INJECTABLE · INTRAVENOUS
OXALIPLATINDiscontinued
OXALIPLATIN 50MG/VIAL · INJECTABLE · INTRAVENOUS

Approval history

2013-03-20Labeling · Supplement 2 · standardLabelAP
2009-08-07OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA 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 →