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FDA ANDA · ANDA211641

DEFERASIROX

Sponsor: SUN PHARM

APPLICATION
ANDA211641
TYPE
ANDA
ORIGINAL APPROVAL
2020-01-02
LATEST ACTION
2024-12-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

DEFERASIROXDiscontinued
DEFERASIROX 360MG · TABLET · ORAL
DEFERASIROXDiscontinued
DEFERASIROX 180MG · TABLET · ORAL
DEFERASIROXDiscontinued
DEFERASIROX 90MG · TABLET · ORAL

Approval history

2024-12-16Labeling · Supplement 2 · standardAP
2020-06-15UNKNOWN · Original · standard — Letter ↗AP
2020-05-14Labeling · Supplement 1 · standardAP
2020-01-02UNKNOWN · 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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