U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Orange Book Home

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for ANDA 077854

Expand all

PRAMIPEXOLE DIHYDROCHLORIDE (PRAMIPEXOLE DIHYDROCHLORIDE)
0.125MG
Marketing Status: Discontinued
Active Ingredient: PRAMIPEXOLE DIHYDROCHLORIDE
Proprietary Name: PRAMIPEXOLE DIHYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.125MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A077854
Product Number: 001
Approval Date: Oct 8, 2010
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
PRAMIPEXOLE DIHYDROCHLORIDE (PRAMIPEXOLE DIHYDROCHLORIDE)
0.25MG
Marketing Status: Discontinued
Active Ingredient: PRAMIPEXOLE DIHYDROCHLORIDE
Proprietary Name: PRAMIPEXOLE DIHYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.25MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A077854
Product Number: 002
Approval Date: Oct 8, 2010
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
PRAMIPEXOLE DIHYDROCHLORIDE (PRAMIPEXOLE DIHYDROCHLORIDE)
0.5MG
Marketing Status: Discontinued
Active Ingredient: PRAMIPEXOLE DIHYDROCHLORIDE
Proprietary Name: PRAMIPEXOLE DIHYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A077854
Product Number: 003
Approval Date: Oct 8, 2010
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
PRAMIPEXOLE DIHYDROCHLORIDE (PRAMIPEXOLE DIHYDROCHLORIDE)
1MG
Marketing Status: Discontinued
Active Ingredient: PRAMIPEXOLE DIHYDROCHLORIDE
Proprietary Name: PRAMIPEXOLE DIHYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A077854
Product Number: 004
Approval Date: Oct 8, 2010
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
PRAMIPEXOLE DIHYDROCHLORIDE (PRAMIPEXOLE DIHYDROCHLORIDE)
1.5MG
Marketing Status: Discontinued
Active Ingredient: PRAMIPEXOLE DIHYDROCHLORIDE
Proprietary Name: PRAMIPEXOLE DIHYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A077854
Product Number: 005
Approval Date: Oct 8, 2010
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
Back to Top