APPLICATION
ANDA078610
TYPE
ANDA
ORIGINAL APPROVAL
2009-02-11
LATEST ACTION
2011-09-07
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
FLUDARABINE PHOSPHATEPrescription
FLUDARABINE PHOSPHATE 50MG/VIAL · INJECTABLE · INJECTION
Approval history
2011-09-07Labeling · Supplement 3AP
2010-05-24Labeling · Supplement 1AP
2009-02-11OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.