Pradaxa

Lowers the risk of stroke and systemic embolism. NDA 22512, held by Boehringer Ingelheim. Dabigatran Etexilate Mesylate.

As of Nov 14, 2026, NDA 22512 (Pradaxa), held by Boehringer Ingelheim, was first approved by FDA on Oct 19, 2010, with 31 approved supplements and 0 published complete response letters.

First approved: Oct 19, 2010
Review: Priority
Supplements approved: 31
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

PRADAXA Capsules is a direct thrombin inhibitor indicated: To reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5-10 days To reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated For the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery For the treatment of venous thromboembolic events (VTE) in pediatric patients 8 to less than 18 years of age who have been treated with a parenteral anticoagulant for at least 5…

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 32 submissions below


Jun 21, 2021	Supplement 41Efficacy (new indication or use) · Priority review	Approved	Patient Package Insert Letter Label
Nov 20, 2015	Supplement 28Efficacy (new indication or use) · Standard review	Approved	Label Letter
Apr 4, 2014	Supplement 18Efficacy (new indication or use) · Standard review	Approved	Letter Label
Oct 19, 2010	Original applicationNew molecular entity · Priority review	Approved	Summary Review Review Label Letter

Products

3 strengths and forms


PradaxaEQ 75MG BASE · capsule;oral	Dabigatran Etexilate Mesylate	RxReference drug
PradaxaEQ 150MG BASE · capsule;oral	Dabigatran Etexilate Mesylate	RxReference drug
PradaxaEQ 110MG BASE · capsule;oral	Dabigatran Etexilate Mesylate	RxReference drug

All 32 submissions, including labeling and manufacturing supplements


Jun 17, 2025	Supplement 49Labeling · Standard review	Approved	Label Letter Medication Guide
Nov 17, 2023	Supplement 47Labeling · Standard review	Approved	Label Letter
Jun 21, 2021	Supplement 41Efficacy (new indication or use) · Priority review	Approved	Patient Package Insert Letter Label
Apr 20, 2021	Supplement 42Labeling · Standard review	Approved	Letter Label
Jul 1, 2020	Supplement 39Labeling · Standard review	Approved	Letter Label
Nov 22, 2019	Supplement 38Labeling · Standard review	Approved	Letter Label
Mar 13, 2018	Supplement 35Labeling · Standard review	Approved	Label Letter
Jul 28, 2016	Supplement 33Manufacturing · Priority review	Approved	None posted
Nov 20, 2015	Supplement 28Efficacy (new indication or use) · Standard review	Approved	Label Letter
Oct 23, 2015	Supplement 32Labeling · Standard review	Approved	Label Letter
Sep 10, 2015	Supplement 27Labeling · Standard review	Approved	Letter Label
Aug 26, 2015	Supplement 31Labeling · Standard review	Approved	Label Letter
Apr 7, 2015	Supplement 26Manufacturing · Priority review	Approved	None posted
Jan 15, 2015	Supplement 24Labeling · Standard review	Approved	Letter Label
Sep 4, 2014	Supplement 25Labeling · Standard review	Approved	Label Letter
Aug 14, 2014	Supplement 23Labeling · Standard review	Approved	Letter Label
Jul 25, 2014	Supplement 22Manufacturing · Priority review	Approved	None posted
Apr 16, 2014	Supplement 20Manufacturing · Priority review	Approved	None posted
Apr 4, 2014	Supplement 18Efficacy (new indication or use) · Standard review	Approved	Letter Label
Dec 10, 2013	Supplement 21Labeling · Standard review	Approved	Letter Label
Oct 18, 2013	Supplement 19Manufacturing · Priority review	Approved	None posted
Apr 25, 2013	Supplement 17Labeling · Standard review	Approved	Letter Label
Dec 19, 2012	Supplement 16Labeling · Standard review	Approved	Letter Label
Nov 20, 2012	Supplement 15Manufacturing · Priority review	Approved	None posted
Nov 2, 2012	Supplement 14Labeling	Approved	Letter Label
May 31, 2012	Supplement 11Labeling	Approved	Review Label Letter
Apr 27, 2012	Supplement 10Labeling	Approved	Letter Label
Jan 17, 2012	Supplement 9Labeling	Approved	Label Letter
Nov 9, 2011	Supplement 7Labeling	Approved	Letter Label
Apr 5, 2011	Supplement 5REMS	Approved	Letter
Mar 4, 2011	Supplement 4Labeling	Approved	Review Letter Label
Oct 19, 2010	Original applicationNew molecular entity · Priority review	Approved	Summary Review Review Label Letter

Identifiers

Application: NDA 22512
Drugs@FDA: Overview at FDA
Company: Boehringer Ingelheim Pharmaceuticals, Inc.

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters