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FDA NDA · NDA202155

ELIQUIS

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APPLICATION
NDA202155
TYPE
NDA
ORIGINAL APPROVAL
2012-12-28
LATEST ACTION
2026-06-24
ROUTE
ORAL
DOSAGE FORM
TABLET, FOR SUSPENSION, TABLET
MARKETING STATUS
Prescription

Products

ELIQUIS · ReferencePrescription
APIXABAN 0.5MG · TABLET, FOR SUSPENSION · ORAL
ELIQUIS · ReferencePrescription
APIXABAN 2.5MG · TABLET · ORAL
ELIQUIS · ReferencePrescription
APIXABAN 5MG · TABLET · ORAL

Approval history

2026-06-24Labeling · Supplement 42 · standard — Letter ↗AP
2025-04-17Efficacy · Supplement 39 · priority — Letter ↗AP
2025-04-17Efficacy · Supplement 40 · priority — Letter ↗AP
2021-10-12Labeling · Supplement 34 · standard — Label ↗AP
2021-04-20Labeling · Supplement 32 · standard — Letter ↗AP
2019-11-26Labeling · Supplement 24 · standard — Letter ↗AP
2019-06-03Labeling · Supplement 21 · standard — Label ↗AP
2018-06-28Labeling · Supplement 20 · standard — Label ↗AP
2018-02-09Labeling · Supplement 18 · standard — Label ↗AP
2017-11-29Labeling · Supplement 17 · standard — Label ↗AP
2016-07-20Labeling · Supplement 12 · standard — Label ↗AP
2016-05-03Manufacturing (CMC) · Supplement 13 · priority — Review ↗AP
2016-03-02REMS · Supplement 14 — Letter ↗AP
2015-09-10Labeling · Supplement 11 · standard — Letter ↗AP
2015-06-16Labeling · Supplement 10 · standard — Label ↗AP
2015-05-01Manufacturing (CMC) · Supplement 8 · priorityAP
2015-03-09Manufacturing (CMC) · Supplement 5 · priorityAP
2014-08-21Efficacy · Supplement 6 · standard — Letter ↗AP
2014-08-12REMS · Supplement 9 — Label ↗AP
2014-04-30Manufacturing (CMC) · Supplement 7 · priorityAP
2014-03-13Efficacy · Supplement 3 · standard — Label ↗AP
2014-01-30Labeling · Supplement 2 · standard — Label ↗AP
2013-10-31Labeling · Supplement 4 · standard — Label ↗AP
2013-07-16Manufacturing (CMC) · Supplement 1 · priorityAP
2012-12-28Type 1 - New Molecular Entity · Original · priority — Letter ↗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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