APPLICATION
ANDA090101
TYPE
ANDA
ORIGINAL APPROVAL
2008-11-26
LATEST ACTION
2013-04-29
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued, Prescription
Products
IRINOTECAN HYDROCHLORIDEDiscontinued
IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) · INJECTABLE · INJECTION
IRINOTECAN HYDROCHLORIDEDiscontinued
IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) · INJECTABLE · INJECTION
IRINOTECAN HYDROCHLORIDEPrescription
IRINOTECAN HYDROCHLORIDE 500MG/25ML (20MG/ML) · INJECTABLE · INJECTION
Approval history
2013-04-29Labeling · Supplement 17 · standardAP
2013-04-29Labeling · Supplement 18 · standardAP
2008-11-26OriginalAP
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.
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