← FDA DRUG APPROVALS

FDA ANDA · ANDA090016

IRINOTECAN HYDROCHLORIDE

Sponsor: HISUN PHARM HANGZHOU

APPLICATION
ANDA090016
TYPE
ANDA
ORIGINAL APPROVAL
2009-01-28
LATEST ACTION
2009-01-28
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

IRINOTECAN HYDROCHLORIDEDiscontinued
IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) · INJECTABLE · INJECTION
IRINOTECAN HYDROCHLORIDEDiscontinued
IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) · INJECTABLE · INJECTION

Approval history

2009-01-28OriginalAP
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 →