← FDA DRUG APPROVALS

FDA ANDA · ANDA214194

DEFERASIROX

Sponsor: AMNEAL

APPLICATION
ANDA214194
TYPE
ANDA
ORIGINAL APPROVAL
2021-02-09
LATEST ACTION
2021-08-02
ROUTE
ORAL
DOSAGE FORM
GRANULE
MARKETING STATUS
Discontinued

Products

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

Approval history

2021-08-02Manufacturing (CMC) · Supplement 1AP
2021-02-09UNKNOWN · Original · standardAP
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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →