← FDA DRUG APPROVALS

FDA NDA · NDA202570

XALKORI

crizotinib

Sponsor: PF PRISM CV

APPLICATION
NDA202570
TYPE
NDA
ORIGINAL APPROVAL
2011-08-26
LATEST ACTION
2023-09-07
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

XALKORI · ReferencePrescription
CRIZOTINIB 250MG · CAPSULE · ORAL
XALKORI · ReferencePrescription
CRIZOTINIB 200MG · CAPSULE · ORAL

Approval history

2023-09-07Efficacy · Supplement 36 · standard — Label ↗AP
2022-07-14Efficacy · Supplement 33 · priority — Label ↗AP
2021-09-22Labeling · Supplement 31 · standard — Label ↗AP
2021-01-14Efficacy · Supplement 30 · priority — Label ↗AP
2019-06-25Labeling · Supplement 28 · standard — Letter ↗AP
2018-12-06Labeling · Supplement 27 · standard — Label ↗AP
2018-11-30Efficacy · Supplement 26 · standard — Label ↗AP
2018-02-07Labeling · Supplement 23 · standard — Label ↗AP
2018-02-07Labeling · Supplement 24 · standard — Letter ↗AP
2017-07-21Labeling · Supplement 21 · standard — Label ↗AP
2017-04-28Efficacy · Supplement 19 · standard — Label ↗AP
2017-01-24Labeling · Supplement 20 · standard — Label ↗AP
2016-04-29Labeling · Supplement 17 · standard — Label ↗AP
2016-04-28Labeling · Supplement 18 · standard — Label ↗AP
2016-03-11Efficacy · Supplement 16 · priority — Letter ↗AP
2015-12-07Manufacturing (CMC) · Supplement 15 · priorityAP
2015-09-14Efficacy · Supplement 14 · standard — Label ↗AP
2015-03-20Labeling · Supplement 13 · standard — Letter ↗AP
2014-08-26Manufacturing (CMC) · Supplement 12 · priorityAP
2014-05-28Labeling · Supplement 11 · standard — Label ↗AP
2014-02-14Manufacturing (CMC) · Supplement 10 · priorityAP
2013-11-20Efficacy · Supplement 6 · standard — Label ↗AP
2013-10-07Labeling · Supplement 9 · standard — Label ↗AP
2013-10-07Labeling · Supplement 7 · standard — Label ↗AP
2013-09-13Manufacturing (CMC) · Supplement 8 · priorityAP
2013-03-12Manufacturing (CMC) · Supplement 5 · priorityAP
2013-02-28Labeling · Supplement 4 · standard — Letter ↗AP
2012-02-24Labeling · Supplement 3 · standard — Label ↗AP
2012-02-17Labeling · Supplement 2 · standard — Label ↗AP
2011-08-26Type 1 - New Molecular Entity · Original · priority — Summary 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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