APPLICATION
ANDA090675
TYPE
ANDA
ORIGINAL APPROVAL
2011-12-16
LATEST ACTION
2025-05-23
ROUTE
INTRAVENOUS, 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
2025-05-23Labeling · Supplement 13 · standardAP
2025-05-23Labeling · Supplement 5 · standardAP
2025-05-23Labeling · Supplement 11 · standardAP
2025-05-23Labeling · Supplement 10 · standardAP
2013-04-29Labeling · Supplement 1AP
2011-12-16Labeling · Supplement 19AP
2011-12-16Labeling · Supplement 17AP
2011-12-16OriginalAP
2011-12-16Efficacy · Supplement 18AP
2011-12-16Labeling · Supplement 16AP
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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