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FDA ANDA · ANDA209433

DEFERASIROX

Sponsor: GLENMARK SPECLT

APPLICATION
ANDA209433
TYPE
ANDA
ORIGINAL APPROVAL
2020-01-03
LATEST ACTION
2023-05-19
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

2023-05-19Labeling · Supplement 1 · standardAP
2023-05-19Labeling · Supplement 2 · standardAP
2020-01-03UNKNOWN · Original · standardAP
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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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