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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020667

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MIRAPEX (PRAMIPEXOLE DIHYDROCHLORIDE)
0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: PRAMIPEXOLE DIHYDROCHLORIDE
Proprietary Name: MIRAPEX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020667
Product Number: 001
Approval Date: Jul 1, 1997
Applicant Holder Full Name: BOEHRINGER INGELHEIM
Marketing Status:  Discontinued
Patent and Exclusivity Information
MIRAPEX (PRAMIPEXOLE DIHYDROCHLORIDE)
0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: PRAMIPEXOLE DIHYDROCHLORIDE
Proprietary Name: MIRAPEX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020667
Product Number: 002
Approval Date: Jul 1, 1997
Applicant Holder Full Name: BOEHRINGER INGELHEIM
Marketing Status:  Discontinued
Patent and Exclusivity Information
MIRAPEX (PRAMIPEXOLE DIHYDROCHLORIDE)
0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: PRAMIPEXOLE DIHYDROCHLORIDE
Proprietary Name: MIRAPEX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020667
Product Number: 006
Approval Date: Feb 12, 1998
Applicant Holder Full Name: BOEHRINGER INGELHEIM
Marketing Status:  Discontinued
Patent and Exclusivity Information
MIRAPEX (PRAMIPEXOLE DIHYDROCHLORIDE)
0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: PRAMIPEXOLE DIHYDROCHLORIDE
Proprietary Name: MIRAPEX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020667
Product Number: 007
Approval Date: Jul 30, 2007
Applicant Holder Full Name: BOEHRINGER INGELHEIM
Marketing Status:  Discontinued
Patent and Exclusivity Information
MIRAPEX (PRAMIPEXOLE DIHYDROCHLORIDE)
1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: PRAMIPEXOLE DIHYDROCHLORIDE
Proprietary Name: MIRAPEX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020667
Product Number: 003
Approval Date: Jul 1, 1997
Applicant Holder Full Name: BOEHRINGER INGELHEIM
Marketing Status:  Discontinued
Patent and Exclusivity Information
MIRAPEX (PRAMIPEXOLE DIHYDROCHLORIDE)
1.25MG
Marketing Status: Discontinued
Active Ingredient: PRAMIPEXOLE DIHYDROCHLORIDE
Proprietary Name: MIRAPEX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1.25MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N020667
Product Number: 004
Approval Date: Jul 1, 1997
Applicant Holder Full Name: BOEHRINGER INGELHEIM
Marketing Status:  Discontinued
Patent and Exclusivity Information
MIRAPEX (PRAMIPEXOLE DIHYDROCHLORIDE)
1.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: PRAMIPEXOLE DIHYDROCHLORIDE
Proprietary Name: MIRAPEX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020667
Product Number: 005
Approval Date: Jul 1, 1997
Applicant Holder Full Name: BOEHRINGER INGELHEIM
Marketing Status:  Discontinued
Patent and Exclusivity Information
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