APPLICATION
ANDA076349
TYPE
ANDA
ORIGINAL APPROVAL
2003-08-28
LATEST ACTION
2011-12-08
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
FLUDARABINE PHOSPHATEPrescription
FLUDARABINE PHOSPHATE 50MG/VIAL · INJECTABLE · INJECTION
Approval history
2011-12-08Labeling · Supplement 14AP
2011-03-21Labeling · Supplement 4AP
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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