APPLICATION
ANDA216229
TYPE
ANDA
ORIGINAL APPROVAL
2022-09-22
LATEST ACTION
2024-03-19
ROUTE
ORAL
DOSAGE FORM
GRANULE
MARKETING STATUS
Prescription
Products
DEFERASIROXPrescription
DEFERASIROX 360MG · GRANULE · ORAL
DEFERASIROXPrescription
DEFERASIROX 90MG · GRANULE · ORAL
DEFERASIROXPrescription
DEFERASIROX 180MG · GRANULE · ORAL
Approval history
2024-03-19Labeling · Supplement 2 · standardAP
2023-03-16Manufacturing (CMC) · Supplement 1 · unknownAP
2022-09-22UNKNOWN · Original · 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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