APPLICATION
ANDA077790
TYPE
ANDA
ORIGINAL APPROVAL
2007-04-06
LATEST ACTION
2009-06-22
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
FLUDARABINE PHOSPHATEDiscontinued
FLUDARABINE PHOSPHATE 50MG/VIAL · INJECTABLE · INJECTION
Approval history
2009-06-22Labeling · Supplement 3AP
2008-06-28Labeling · Supplement 1AP
2007-04-06OriginalAP
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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