Pradaxa

Treats venous thromboembolic events (VTE). NDA 214358, held by Boehringer Ingelheim. Dabigatran Etexilate Mesylate.

As of Nov 14, 2026, NDA 214358 (Pradaxa), held by Boehringer Ingelheim, was first approved by FDA on Jun 21, 2021, with 4 approved supplements and 0 published complete response letters.

First approved: Jun 21, 2021
Review: Priority
Supplements approved: 4
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

PRADAXA Oral Pellets are a direct thrombin inhibitor indicated: For the treatment of venous thromboembolic events (VTE) in pediatric patients aged 3 months to less than 12 years of age who have been treated with a parenteral anticoagulant for at least 5 days To reduce the risk of recurrence of VTE in pediatric patients aged 3 months to less than 12 years of age who have been previously treated 1.1 Treatment of Venous Thromboembolic Events in Pediatric Patients PRADAXA Oral Pellets are indicated for the treatment of venous thromboembolic events (VTE) in pediatric patients aged 3 months to less than 12 years of age who have been treated with a parenteral anticoagulant for at least 5 days. 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Jun 21, 2021	Original applicationNew dosage form · Priority review	Approved	Review Letter Label

Products

6 strengths and forms


PradaxaEQ 20MG BASE/PACKET · pellets;oral	Dabigatran Etexilate Mesylate	DiscontinuedReference drug
PradaxaEQ 30MG BASE/PACKET · pellets;oral	Dabigatran Etexilate Mesylate	DiscontinuedReference drug
PradaxaEQ 40MG BASE/PACKET · pellets;oral	Dabigatran Etexilate Mesylate	DiscontinuedReference drug
PradaxaEQ 50MG BASE/PACKET · pellets;oral	Dabigatran Etexilate Mesylate	DiscontinuedReference drug
PradaxaEQ 110MG BASE/PACKET · pellets;oral	Dabigatran Etexilate Mesylate	DiscontinuedReference drug
PradaxaEQ 150MG BASE/PACKET · pellets;oral	Dabigatran Etexilate Mesylate	DiscontinuedReference drug

All 5 submissions, including labeling and manufacturing supplements


Jun 17, 2025	Supplement 9Labeling · Standard review	Approved	Label Letter Medication Guide
Nov 14, 2023	Supplement 7Labeling · Standard review	Approved	Letter Label
Mar 25, 2022	Supplement 1Labeling · Standard review	Approved	Label Letter
Mar 4, 2022	Supplement 2Manufacturing · Standard review	Approved	None posted
Jun 21, 2021	Original applicationNew dosage form · Priority review	Approved	Review Letter Label

Identifiers

Application: NDA 214358
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