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FDA NDA · NDA021399

IRESSA

Sponsor: ASTRAZENECA

APPLICATION
NDA021399
TYPE
NDA
ORIGINAL APPROVAL
2003-05-05
LATEST ACTION
2005-06-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

IRESSADiscontinued
GEFITINIB 250MG · TABLET · ORAL

Approval history

2005-06-17Labeling · Supplement 8 · priority — Letter ↗AP
2004-11-19Labeling · Supplement 5 · priority — Letter ↗AP
2004-05-06Labeling · Supplement 3 · priority — Label ↗AP
2003-05-05Type 1 - New Molecular Entity · Original · priority — Review ↗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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