NDA 022514

BOEHRINGER INGELHEIM

FDA Drug Application

Application #022514

Documents

• Letter: 2010-03-24
• Label: 2010-03-26
• Review: 2010-09-03
• Other Important Information from FDA: 2012-09-19
• Summary Review: 2010-09-03

Application Sponsors

NDA 022514

BOEHRINGER INGELHEIM

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005

Application Products

001	TABLET, EXTENDED RELEASE; ORAL	0.375MG	0	MIRAPEX ER	PRAMIPEXOLE DIHYDROCHLORIDE
002	TABLET, EXTENDED RELEASE; ORAL	0.75MG	0	MIRAPEX ER	PRAMIPEXOLE DIHYDROCHLORIDE
003	TABLET, EXTENDED RELEASE; ORAL	1.5MG	0	MIRAPEX ER	PRAMIPEXOLE DIHYDROCHLORIDE
004	TABLET, EXTENDED RELEASE; ORAL	3MG	0	MIRAPEX ER	PRAMIPEXOLE DIHYDROCHLORIDE
005	TABLET, EXTENDED RELEASE; ORAL	4.5MG	0	MIRAPEX ER	PRAMIPEXOLE DIHYDROCHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form

ORIG

1

AP

2010-03-19

STANDARD

Submissions Property Types

ORIG

1

Null

6

CDER Filings

Accessdata Error

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