APPLICATION
ANDA076661
TYPE
ANDA
ORIGINAL APPROVAL
2004-04-28
LATEST ACTION
2015-06-14
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
FLUDARABINE PHOSPHATEPrescription
FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) · INJECTABLE · INJECTION
Approval history
2015-06-14Labeling · Supplement 14AP
2004-04-28OriginalAP
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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