APPLICATION
ANDA203560
TYPE
ANDA
ORIGINAL APPROVAL
2016-01-26
LATEST ACTION
2025-10-21
ROUTE
ORAL
DOSAGE FORM
TABLET, FOR SUSPENSION
MARKETING STATUS
Prescription
Products
DEFERASIROXPrescription
DEFERASIROX 250MG · TABLET, FOR SUSPENSION · ORAL
DEFERASIROXPrescription
DEFERASIROX 500MG · TABLET, FOR SUSPENSION · ORAL
DEFERASIROXPrescription
DEFERASIROX 125MG · TABLET, FOR SUSPENSION · ORAL
Approval history
2025-10-21Labeling · Supplement 5 · standardAP
2025-10-21Labeling · Supplement 8 · standardAP
2025-10-21Labeling · Supplement 6 · standardAP
2025-10-21Labeling · Supplement 4 · standardAP
2025-10-21Labeling · Supplement 14 · standardAP
2025-10-21Labeling · Supplement 12 · standardAP
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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