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PRADAXA

NDA · New Drug Application · Sponsor: BOEHRINGER INGELHEIM · Approved 2021-06-21

Drug application

FDA Application #

NDA214358

Application type

New Drug Application

Brand name

PRADAXA

Generic name

DABIGATRAN ETEXILATE

Active ingredients

DABIGATRAN ETEXILATE MESYLATE

Dosage form

PELLETS

Route

ORAL

Marketing status

Prescription

Sponsor

BOEHRINGER INGELHEIM

Manufacturer

Boehringer Ingelheim Pharmaceuticals, Inc.

First approval

2021-06-21

Source

Authoritative

Drugs@FDA application overview

Machine

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