← FDA DRUG APPROVALS

FDA NDA · NDA203469

ICLUSIG

ponatinib hydrochloride

Sponsor: TAKEDA PHARMS USA

APPLICATION
NDA203469
TYPE
NDA
ORIGINAL APPROVAL
2012-12-14
LATEST ACTION
2025-10-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

ICLUSIG · ReferencePrescription
PONATINIB HYDROCHLORIDE EQ 10MG BASE · TABLET · ORAL
ICLUSIG · ReferencePrescription
PONATINIB HYDROCHLORIDE EQ 45MG BASE · TABLET · ORAL
ICLUSIG · ReferencePrescription
PONATINIB HYDROCHLORIDE EQ 30MG BASE · TABLET · ORAL
ICLUSIG · ReferencePrescription
PONATINIB HYDROCHLORIDE EQ 15MG BASE · TABLET · ORAL

Approval history

2025-10-10Efficacy · Supplement 38 · standard — Label ↗AP
2024-03-19Efficacy · Supplement 37 · priority — Label ↗AP
2022-02-15Efficacy · Supplement 35 · standard — Letter ↗AP
2020-12-18Efficacy · Supplement 34 · priority — Label ↗AP
2020-07-10Labeling · Supplement 33 · standard — Letter ↗AP
2020-06-17Labeling · Supplement 32 · standard — Letter ↗AP
2020-01-10Labeling · Supplement 31 · standard — Letter ↗AP
2018-10-18Labeling · Supplement 30 · standard — Letter ↗AP
2018-05-29REMS · Supplement 29 — Letter ↗AP
2017-12-20Labeling · Supplement 27 · standard — Label ↗AP
2017-12-20Labeling · Supplement 28 · standard — Label ↗AP
2016-11-28Efficacy · Supplement 22 · standard — Letter ↗AP
2016-09-07Labeling · Supplement 24 · standard — Letter ↗AP
2016-08-31Labeling · Supplement 23 · standard — Letter ↗AP
2016-06-02Efficacy · Supplement 21 · standard — Label ↗AP
2015-12-02Labeling · Supplement 20 · standard — Label ↗AP
2015-12-01Manufacturing (CMC) · Supplement 19 · priorityAP
2015-08-24Manufacturing (CMC) · Supplement 18 · priorityAP
2015-05-20Manufacturing (CMC) · Supplement 15 · priorityAP
2015-04-23Manufacturing (CMC) · Supplement 17 · priorityAP
2015-04-17Manufacturing (CMC) · Supplement 16 · priorityAP
2015-02-03Manufacturing (CMC) · Supplement 14 · priorityAP
2015-01-20Manufacturing (CMC) · Supplement 13 · priorityAP
2014-09-09Manufacturing (CMC) · Supplement 12 · priorityAP
2014-08-15Manufacturing (CMC) · Supplement 11 · priorityAP
2014-07-30Manufacturing (CMC) · Supplement 10 · priorityAP
2014-07-24Labeling · Supplement 9 · standard — Label ↗AP
2014-03-27Manufacturing (CMC) · Supplement 6 · priorityAP
2014-01-30Manufacturing (CMC) · Supplement 4 · priorityAP
2013-12-20Labeling · Supplement 7 — Review ↗AP
2013-12-20REMS · Supplement 8 — Label ↗AP
2013-08-12Manufacturing (CMC) · Supplement 3 · priorityAP
2013-06-25Manufacturing (CMC) · Supplement 2 · priorityAP
2012-12-14Type 1 - New Molecular Entity · Original · priority — Review ↗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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