APPLICATION
ANDA203738
TYPE
ANDA
ORIGINAL APPROVAL
2017-02-28
LATEST ACTION
2025-07-01
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
FLUDARABINE PHOSPHATEDiscontinued
FLUDARABINE PHOSPHATE 50MG/2ML (25MG/ML) · INJECTABLE · INJECTION
Approval history
2025-07-01Labeling · Supplement 3 · standardAP
2017-02-28UNKNOWN · OriginalAP
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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