Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022421

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MIRAPEX ER (PRAMIPEXOLE DIHYDROCHLORIDE)
0.375MG
Marketing Status: Prescription

Active Ingredient: PRAMIPEXOLE DIHYDROCHLORIDE
Proprietary Name: MIRAPEX ER
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 0.375MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N022421
Product Number: 001
Approval Date: Feb 19, 2010
Applicant Holder Full Name: BOEHRINGER INGELHEIM PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

MIRAPEX ER (PRAMIPEXOLE DIHYDROCHLORIDE)
0.75MG
Marketing Status: Prescription

Active Ingredient: PRAMIPEXOLE DIHYDROCHLORIDE
Proprietary Name: MIRAPEX ER
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 0.75MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N022421
Product Number: 002
Approval Date: Feb 19, 2010
Applicant Holder Full Name: BOEHRINGER INGELHEIM PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

MIRAPEX ER (PRAMIPEXOLE DIHYDROCHLORIDE)
1.5MG
Marketing Status: Prescription

Active Ingredient: PRAMIPEXOLE DIHYDROCHLORIDE
Proprietary Name: MIRAPEX ER
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 1.5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N022421
Product Number: 003
Approval Date: Feb 19, 2010
Applicant Holder Full Name: BOEHRINGER INGELHEIM PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

MIRAPEX ER (PRAMIPEXOLE DIHYDROCHLORIDE)
2.25MG
Marketing Status: Prescription

Active Ingredient: PRAMIPEXOLE DIHYDROCHLORIDE
Proprietary Name: MIRAPEX ER
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 2.25MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N022421
Product Number: 006
Approval Date: Jun 17, 2011
Applicant Holder Full Name: BOEHRINGER INGELHEIM PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

MIRAPEX ER (PRAMIPEXOLE DIHYDROCHLORIDE)
3MG
Marketing Status: Prescription

Active Ingredient: PRAMIPEXOLE DIHYDROCHLORIDE
Proprietary Name: MIRAPEX ER
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 3MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N022421
Product Number: 004
Approval Date: Feb 19, 2010
Applicant Holder Full Name: BOEHRINGER INGELHEIM PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

MIRAPEX ER (PRAMIPEXOLE DIHYDROCHLORIDE)
3.75MG
Marketing Status: Prescription

Active Ingredient: PRAMIPEXOLE DIHYDROCHLORIDE
Proprietary Name: MIRAPEX ER
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 3.75MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N022421
Product Number: 007
Approval Date: Jun 17, 2011
Applicant Holder Full Name: BOEHRINGER INGELHEIM PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

MIRAPEX ER (PRAMIPEXOLE DIHYDROCHLORIDE)
4.5MG
Marketing Status: Prescription

Active Ingredient: PRAMIPEXOLE DIHYDROCHLORIDE
Proprietary Name: MIRAPEX ER
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 4.5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N022421
Product Number: 005
Approval Date: Feb 19, 2010
Applicant Holder Full Name: BOEHRINGER INGELHEIM PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information