APPLICATION
ANDA078188
TYPE
ANDA
ORIGINAL APPROVAL
2008-02-27
LATEST ACTION
2011-03-16
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
2011-03-16Labeling · Supplement 5AP
2010-06-21Labeling · Supplement 2AP
2009-05-26Labeling · Supplement 4AP
2008-02-27OriginalAP
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.