APPLICATION
ANDA212995
TYPE
ANDA
ORIGINAL APPROVAL
2019-12-30
LATEST ACTION
2024-11-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
DEFERASIROXPrescription
DEFERASIROX 180MG · TABLET · ORAL
DEFERASIROXPrescription
DEFERASIROX 90MG · TABLET · ORAL
DEFERASIROXPrescription
DEFERASIROX 360MG · TABLET · ORAL
Approval history
2024-11-07Labeling · Supplement 2 · standardAP
2020-06-15UNKNOWN · Original · standardAP
2020-04-13Labeling · Supplement 1 · standardAP
2019-12-30UNKNOWN · 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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