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FDA NDA · NDA021335

GLEEVEC

Sponsor: NOVARTIS

APPLICATION
NDA021335
TYPE
NDA
ORIGINAL APPROVAL
2001-05-10
LATEST ACTION
2003-10-31
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

GLEEVEC · ReferenceDiscontinued
IMATINIB MESYLATE EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
GLEEVEC · ReferenceDiscontinued
IMATINIB MESYLATE EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL

Approval history

2003-10-31Labeling · Supplement 6 · priority — Review ↗AP
2003-05-20Efficacy · Supplement 3 · priority — Label ↗AP
2002-12-20Efficacy · Supplement 4 · priority — Label ↗AP
2002-02-01Efficacy · Supplement 1 · priority — Label ↗AP
2002-01-22Manufacturing (CMC) · Supplement 2 · priority — Label ↗AP
2001-05-10Type 1 - New Molecular Entity · Original · priority — Other Important Information from FDA ↗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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