← FDA DRUG APPROVALS

FDA NDA · NDA022512

PRADAXA

dabigatran etexilate mesylate

Sponsor: BOEHRINGER INGELHEIM

APPLICATION
NDA022512
TYPE
NDA
ORIGINAL APPROVAL
2010-10-19
LATEST ACTION
2025-06-17
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

PRADAXA · ReferencePrescription
DABIGATRAN ETEXILATE MESYLATE EQ 110MG BASE · CAPSULE · ORAL
PRADAXA · ReferencePrescription
DABIGATRAN ETEXILATE MESYLATE EQ 75MG BASE · CAPSULE · ORAL
PRADAXA · ReferencePrescription
DABIGATRAN ETEXILATE MESYLATE EQ 150MG BASE · CAPSULE · ORAL

Approval history

2025-06-17Labeling · Supplement 49 · standard — Label ↗AP
2023-11-17Labeling · Supplement 47 · standard — Letter ↗AP
2021-06-21Efficacy · Supplement 41 · priority — Label ↗AP
2021-04-20Labeling · Supplement 42 · standard — Letter ↗AP
2020-07-01Labeling · Supplement 39 · standard — Label ↗AP
2019-11-22Labeling · Supplement 38 · standard — Label ↗AP
2018-03-13Labeling · Supplement 35 · standard — Label ↗AP
2016-07-28Manufacturing (CMC) · Supplement 33 · priorityAP
2015-11-20Efficacy · Supplement 28 · standard — Letter ↗AP
2015-10-23Labeling · Supplement 32 · standard — Label ↗AP
2015-09-10Labeling · Supplement 27 · standard — Label ↗AP
2015-08-26Labeling · Supplement 31 · standard — Label ↗AP
2015-04-07Manufacturing (CMC) · Supplement 26 · priorityAP
2015-01-15Labeling · Supplement 24 · standard — Label ↗AP
2014-09-04Labeling · Supplement 25 · standard — Label ↗AP
2014-08-14Labeling · Supplement 23 · standard — Label ↗AP
2014-07-25Manufacturing (CMC) · Supplement 22 · priorityAP
2014-04-16Manufacturing (CMC) · Supplement 20 · priorityAP
2014-04-04Efficacy · Supplement 18 · standard — Label ↗AP
2013-12-10Labeling · Supplement 21 · standard — Label ↗AP
2013-10-18Manufacturing (CMC) · Supplement 19 · priorityAP
2013-04-25Labeling · Supplement 17 · standard — Letter ↗AP
2012-12-19Labeling · Supplement 16 · standard — Label ↗AP
2012-11-20Manufacturing (CMC) · Supplement 15 · priorityAP
2012-11-02Labeling · Supplement 14 · unknown — Label ↗AP
2012-05-31Labeling · Supplement 11 · unknown — Review ↗AP
2012-04-27Labeling · Supplement 10 · unknown — Label ↗AP
2012-01-17Labeling · Supplement 9 · unknown — Label ↗AP
2011-11-09Labeling · Supplement 7 · unknown — Label ↗AP
2011-04-05REMS · Supplement 5 — Letter ↗AP
2011-03-04Labeling · Supplement 4 · unknown — Label ↗AP
2010-10-19Type 1 - New Molecular Entity · Original · priority — Other Important Information from FDA ↗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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