Product Details for ANDA 090781
PRAMIPEXOLE DIHYDROCHLORIDE (PRAMIPEXOLE DIHYDROCHLORIDE)
0.125MG
Marketing Status: Prescription
0.25MG
Marketing Status: Prescription
0.5MG
Marketing Status: Prescription
0.75MG
Marketing Status: Prescription
1MG
Marketing Status: Prescription
1.5MG
Marketing Status: Prescription
0.125MG
Marketing Status: Prescription
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: AB
Application Number: A090781
Product Number: 001
Approval Date: Oct 8, 2010
Applicant Holder Full Name: GLENMARK PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
PRAMIPEXOLE DIHYDROCHLORIDE (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: AB
Application Number: A090781
Product Number: 001
Approval Date: Oct 8, 2010
Applicant Holder Full Name: GLENMARK PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
0.25MG
Marketing Status: Prescription
Active Ingredient: PRAMIPEXOLE DIHYDROCHLORIDE
Proprietary Name: PRAMIPEXOLE DIHYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.25MG
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AB
Application Number: A090781
Product Number: 002
Approval Date: Oct 8, 2010
Applicant Holder Full Name: GLENMARK PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
PRAMIPEXOLE DIHYDROCHLORIDE (PRAMIPEXOLE DIHYDROCHLORIDE)
Proprietary Name: PRAMIPEXOLE DIHYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.25MG
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AB
Application Number: A090781
Product Number: 002
Approval Date: Oct 8, 2010
Applicant Holder Full Name: GLENMARK PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
0.5MG
Marketing Status: Prescription
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: AB
Application Number: A090781
Product Number: 003
Approval Date: Oct 8, 2010
Applicant Holder Full Name: GLENMARK PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
PRAMIPEXOLE DIHYDROCHLORIDE (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: AB
Application Number: A090781
Product Number: 003
Approval Date: Oct 8, 2010
Applicant Holder Full Name: GLENMARK PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
0.75MG
Marketing Status: Prescription
Active Ingredient: PRAMIPEXOLE DIHYDROCHLORIDE
Proprietary Name: PRAMIPEXOLE DIHYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.75MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A090781
Product Number: 006
Approval Date: Sep 11, 2015
Applicant Holder Full Name: GLENMARK PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
PRAMIPEXOLE DIHYDROCHLORIDE (PRAMIPEXOLE DIHYDROCHLORIDE)
Proprietary Name: PRAMIPEXOLE DIHYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.75MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A090781
Product Number: 006
Approval Date: Sep 11, 2015
Applicant Holder Full Name: GLENMARK PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
1MG
Marketing Status: Prescription
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: AB
Application Number: A090781
Product Number: 004
Approval Date: Oct 8, 2010
Applicant Holder Full Name: GLENMARK PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
PRAMIPEXOLE DIHYDROCHLORIDE (PRAMIPEXOLE DIHYDROCHLORIDE)
Proprietary Name: PRAMIPEXOLE DIHYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A090781
Product Number: 004
Approval Date: Oct 8, 2010
Applicant Holder Full Name: GLENMARK PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
1.5MG
Marketing Status: Prescription
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: AB
Application Number: A090781
Product Number: 005
Approval Date: Oct 8, 2010
Applicant Holder Full Name: GLENMARK PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: PRAMIPEXOLE DIHYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A090781
Product Number: 005
Approval Date: Oct 8, 2010
Applicant Holder Full Name: GLENMARK PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information