APPLICATION
ANDA208718
TYPE
ANDA
ORIGINAL APPROVAL
2018-12-28
LATEST ACTION
2022-10-28
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
IRINOTECAN HYDROCHLORIDEPrescription
IRINOTECAN HYDROCHLORIDE 300MG/15ML (20MG/ML) · INJECTABLE · INJECTION
IRINOTECAN HYDROCHLORIDEPrescription
IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) · INJECTABLE · INJECTION
IRINOTECAN HYDROCHLORIDEPrescription
IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) · INJECTABLE · INJECTION
Approval history
2022-10-28Labeling · Supplement 8 · standardAP
2022-10-28Labeling · Supplement 10 · standardAP
2020-06-12Labeling · Supplement 5 · standardAP
2018-12-28UNKNOWN · Original · 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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