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FDA NDA · NDA021986

DASATINIB

Sponsor: BRISTOL MYERS SQUIBB

APPLICATION
NDA021986
TYPE
NDA
ORIGINAL APPROVAL
2006-06-28
LATEST ACTION
2024-07-31
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

SPRYCEL · ReferencePrescription
DASATINIB 80MG · TABLET · ORAL
SPRYCEL · ReferencePrescription
DASATINIB 70MG · TABLET · ORAL
SPRYCEL · ReferencePrescription
DASATINIB 20MG · TABLET · ORAL
SPRYCEL · ReferencePrescription
DASATINIB 140MG · TABLET · ORAL
SPRYCEL · ReferencePrescription
DASATINIB 100MG · TABLET · ORAL
SPRYCEL · ReferencePrescription
DASATINIB 50MG · TABLET · ORAL

Approval history

2024-07-31Labeling · Supplement 28 · standard — Letter ↗AP
2023-02-08Labeling · Supplement 27 · standard — Letter ↗AP
2021-06-29Labeling · Supplement 25 · standard — Letter ↗AP
2018-12-21Efficacy · Supplement 21 · priority — Label ↗AP
2018-11-15Labeling · Supplement 23 · standard — Label ↗AP
2017-11-09Efficacy · Supplement 20 · priority — Label ↗AP
2017-08-10Labeling · Supplement 19 · standard — Label ↗AP
2016-09-27Labeling · Supplement 18 · standard — Label ↗AP
2015-08-12Efficacy · Supplement 16 · standard — Letter ↗AP
2015-08-12Labeling · Supplement 17 · standard — Letter ↗AP
2015-01-26Manufacturing (CMC) · Supplement 15 · priorityAP
2014-04-10Labeling · Supplement 14 · standard — Letter ↗AP
2013-06-17Efficacy · Supplement 13 · standard — Label ↗AP
2011-10-07Labeling · Supplement 9 · unknown — Letter ↗AP
2011-10-07Labeling · Supplement 10 · unknown — Letter ↗AP
2010-10-28Efficacy · Supplement 7 · standard — Label ↗AP
2010-10-28Efficacy · Supplement 8 · priority — Letter ↗AP
2010-07-28Labeling · Supplement 5 · standard — Letter ↗AP
2009-05-21Efficacy · Supplement 4 · unknown — Letter ↗AP
2008-05-30Manufacturing (CMC) · Supplement 3 — Letter ↗AP
2007-11-08Efficacy · Supplement 1 · priority — Review ↗AP
2007-11-08Efficacy · Supplement 2 · unknown — Label ↗AP
2006-06-28Type 1 - New Molecular Entity · Original · priority — Label ↗AP
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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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