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PRADAXA

NDA · New Drug Application · Sponsor: BOEHRINGER INGELHEIM · Approved 2010-10-19

Drug application

FDA Application #

NDA022512

Application type

New Drug Application

Brand name

PRADAXA

Generic name

DABIGATRAN ETEXILATE MESYLATE

Active ingredients

DABIGATRAN ETEXILATE MESYLATE

Dosage form

CAPSULE

Route

ORAL

Marketing status

Prescription

Sponsor

BOEHRINGER INGELHEIM

Manufacturer

Boehringer Ingelheim Pharmaceuticals Inc.

First approval

2010-10-19

Source

Authoritative

Drugs@FDA application overview

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