Details for New Drug Application (NDA): 020667

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NDA 020667 describes MIRAPEX, which is a drug marketed by Boehringer Ingelheim and is included in two NDAs. There are two patents protecting this drug and five Paragraph IV challenges. Additional details are available on the MIRAPEX profile page.

The generic ingredient in MIRAPEX is pramipexole dihydrochloride. There are twenty-five drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the pramipexole dihydrochloride profile page.

Summary for 020667

Tradename:	MIRAPEX
Applicant:	Boehringer Ingelheim
Ingredient:	pramipexole dihydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	0.125MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jul 1, 1997	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	0.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jul 1, 1997	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jul 1, 1997	TE:		RLD:	Yes

Expired US Patents for NDA 020667

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	MIRAPEX	pramipexole dihydrochloride	TABLET;ORAL	020667-005	Jul 1, 1997	⤷ Subscribe	⤷ Subscribe
Boehringer Ingelheim	MIRAPEX	pramipexole dihydrochloride	TABLET;ORAL	020667-006	Feb 12, 1998	⤷ Subscribe	⤷ Subscribe
Boehringer Ingelheim	MIRAPEX	pramipexole dihydrochloride	TABLET;ORAL	020667-003	Jul 1, 1997	⤷ Subscribe	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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