APPLICATION
ANDA076078
TYPE
ANDA
ORIGINAL APPROVAL
2002-05-28
LATEST ACTION
2025-09-29
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
IFOSFAMIDEPrescription
IFOSFAMIDE 3GM/VIAL · INJECTABLE · INJECTION
IFOSFAMIDEPrescription
IFOSFAMIDE 1GM/VIAL · INJECTABLE · INJECTION
Approval history
2025-09-29Labeling · Supplement 19 · standardAP
2024-08-19Labeling · Supplement 11 · standardAP
2024-08-19Labeling · Supplement 17 · 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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