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FDA ANDA · ANDA210945

DEFERASIROX

Sponsor: MSN

APPLICATION
ANDA210945
TYPE
ANDA
ORIGINAL APPROVAL
2019-11-20
LATEST ACTION
2024-12-17
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

2024-12-17Labeling · Supplement 7 · standardAP
2021-03-01Manufacturing (CMC) · Supplement 2 · unknownAP
2021-03-01Labeling · Supplement 5 · standardAP
2021-03-01Labeling · Supplement 3 · standardAP
2020-06-16UNKNOWN · Original · standard — Letter ↗AP
2019-11-20UNKNOWN · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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