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Last Updated: November 21, 2024

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:DISCNDosage:TABLET;ORALStrength0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Jul 1, 1997TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Jul 1, 1997TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Jul 1, 1997TE:RLD:Yes

Expired US Patents for NDA 020667

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim MIRAPEX pramipexole dihydrochloride TABLET;ORAL 020667-003 Jul 1, 1997 ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim MIRAPEX pramipexole dihydrochloride TABLET;ORAL 020667-007 Jul 30, 2007 ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim MIRAPEX pramipexole dihydrochloride TABLET;ORAL 020667-006 Feb 12, 1998 ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim MIRAPEX pramipexole dihydrochloride TABLET;ORAL 020667-001 Jul 1, 1997 ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim MIRAPEX pramipexole dihydrochloride TABLET;ORAL 020667-005 Jul 1, 1997 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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