APPLICATION
ANDA200771
TYPE
ANDA
ORIGINAL APPROVAL
2012-02-14
LATEST ACTION
2020-08-24
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription, Discontinued
Products
IRINOTECAN HYDROCHLORIDEPrescription
IRINOTECAN HYDROCHLORIDE 100MG/5ML · INJECTABLE · INJECTION
IRINOTECAN HYDROCHLORIDEDiscontinued
IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) · INJECTABLE · INJECTION
IRINOTECAN HYDROCHLORIDEDiscontinued
IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) · INJECTABLE · INJECTION
Approval history
2020-08-24Labeling · Supplement 6 · standardAP
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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