APPLICATION
ANDA077915
TYPE
ANDA
ORIGINAL APPROVAL
2008-02-27
LATEST ACTION
2023-05-15
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
IRINOTECAN HYDROCHLORIDEPrescription
IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) · INJECTABLE · INJECTION
IRINOTECAN HYDROCHLORIDEPrescription
IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) · INJECTABLE · INJECTION
Approval history
2023-05-15Labeling · Supplement 13 · standardAP
2023-05-15Labeling · Supplement 14 · standardAP
2020-06-19Labeling · Supplement 11 · standardAP
2020-06-19Labeling · Supplement 7 · standardAP
2020-06-19Labeling · Supplement 10 · standardAP
2015-01-02Labeling · Supplement 6 · standardAP
2013-01-24Labeling · Supplement 4 · standardAP
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.
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