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MIRAPEX ER

NDA · New Drug Application · Sponsor: BOEHRINGER INGELHEIM · Approved 2010-03-19

Drug application

FDA Application #

NDA022514

Application type

New Drug Application

Brand name

MIRAPEX ER

Generic name

Pramipexole Dihydrochloride

Active ingredients

PRAMIPEXOLE DIHYDROCHLORIDE

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

Marketing status

Prescription

Sponsor

BOEHRINGER INGELHEIM

First approval

2010-03-19

Source

Authoritative

Drugs@FDA application overview

Machine

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