APPLICATION
ANDA206935
TYPE
ANDA
ORIGINAL APPROVAL
2017-05-26
LATEST ACTION
2024-03-20
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
IRINOTECAN HYDROCHLORIDEPrescription
IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) · INJECTABLE · INJECTION
IRINOTECAN HYDROCHLORIDEPrescription
IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) · INJECTABLE · INJECTION
Approval history
2024-03-20Labeling · Supplement 8 · standardAP
2020-05-21Labeling · Supplement 6 · standardAP
2020-05-21Labeling · Supplement 4 · standardAP
2017-05-26UNKNOWN · 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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