← FDA DRUG APPROVALS

FDA NDA · NDA021588

GLEEVEC

imatinib mesylate

Sponsor: NOVARTIS

APPLICATION
NDA021588
TYPE
NDA
ORIGINAL APPROVAL
2003-04-18
LATEST ACTION
2026-07-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

GLEEVEC · ReferencePrescription
IMATINIB MESYLATE EQ 100MG BASE · TABLET · ORAL
GLEEVEC · ReferencePrescription
IMATINIB MESYLATE EQ 400MG BASE · TABLET · ORAL

Approval history

2026-07-13Labeling · Supplement 67 · standard — Label ↗AP
2026-01-14Labeling · Supplement 65 · standard — Letter ↗AP
2024-03-01Manufacturing (CMC) · Supplement 63 — Letter ↗AP
2022-08-19Labeling · Supplement 62 · standard — Letter ↗AP
2022-03-24Labeling · Supplement 60 · standard — Label ↗AP
2020-08-10Labeling · Supplement 56 · standard — Letter ↗AP
2020-08-10Labeling · Supplement 57 · standard — Letter ↗AP
2018-08-21Labeling · Supplement 53 · standard — Label ↗AP
2017-09-29Labeling · Supplement 52 · standard — Label ↗AP
2017-09-06Labeling · Supplement 51 · 901 required — Label ↗AP
2017-04-24Labeling · Supplement 49 · standard — Label ↗AP
2016-09-27Labeling · Supplement 47 · standard — Label ↗AP
2016-08-25Efficacy · Supplement 45 · standard — Letter ↗AP
2016-08-25Labeling · Supplement 46 · standard — Letter ↗AP
2015-01-30Efficacy · Supplement 42 · standard — Label ↗AP
2014-05-22Labeling · Supplement 40 · standard — Label ↗AP
2013-10-30Labeling · Supplement 39 · standard — Label ↗AP
2013-02-21Labeling · Supplement 38 · standard — Label ↗AP
2013-01-25Efficacy · Supplement 37 · priority — Label ↗AP
2012-01-31Efficacy · Supplement 35 · priority — Letter ↗AP
2011-04-01Labeling · Supplement 31 · standard — Letter ↗AP
2011-04-01Efficacy · Supplement 30 · standard — Letter ↗AP
2009-05-27Labeling · Supplement 28 · standard — Letter ↗AP
2009-05-27Efficacy · Supplement 26 · standard — Letter ↗AP
2009-02-10Labeling · Supplement 27 · standard — Letter ↗AP
2008-12-19Efficacy · Supplement 25 · priority — Letter ↗AP
2008-09-26Labeling · Supplement 21 · standard — Letter ↗AP
2008-09-26Efficacy · Supplement 24 · standard — Letter ↗AP
2008-09-26Labeling · Supplement 22 · standard — Letter ↗AP
2008-04-30Manufacturing (CMC) · Supplement 23 — Letter ↗AP
2007-09-13Efficacy · Supplement 20 · unknown — Letter ↗AP
2006-10-30Labeling · Supplement 9 · standard — Label ↗AP
2006-10-19Efficacy · Supplement 17 · unknown — Review ↗AP
2006-10-19Efficacy · Supplement 13 · standard — Review ↗AP
2006-10-19Efficacy · Supplement 11 · standard — Letter ↗AP
2006-10-19Efficacy · Supplement 14 · unknown — Review ↗AP
2006-10-19Efficacy · Supplement 12 · standard — Label ↗AP
2006-09-27Efficacy · Supplement 16 · priority — Pediatric Medical Review ↗AP
2006-05-31Labeling · Supplement 10 · standard — Label ↗AP
2005-10-20Efficacy · Supplement 8 · unknown — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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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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