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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 213444

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PRAMIPEXOLE DIHYDROCHLORIDE (PRAMIPEXOLE DIHYDROCHLORIDE)
0.375MG
Marketing Status: Prescription
Active Ingredient: PRAMIPEXOLE DIHYDROCHLORIDE
Proprietary Name: PRAMIPEXOLE DIHYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 0.375MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A213444
Product Number: 001
Approval Date: Feb 3, 2022
Applicant Holder Full Name: NOVAST LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
PRAMIPEXOLE DIHYDROCHLORIDE (PRAMIPEXOLE DIHYDROCHLORIDE)
0.75MG
Marketing Status: Prescription
Active Ingredient: PRAMIPEXOLE DIHYDROCHLORIDE
Proprietary Name: PRAMIPEXOLE DIHYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 0.75MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A213444
Product Number: 002
Approval Date: Feb 3, 2022
Applicant Holder Full Name: NOVAST LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
PRAMIPEXOLE DIHYDROCHLORIDE (PRAMIPEXOLE DIHYDROCHLORIDE)
1.5MG
Marketing Status: Prescription
Active Ingredient: PRAMIPEXOLE DIHYDROCHLORIDE
Proprietary Name: PRAMIPEXOLE DIHYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 1.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A213444
Product Number: 003
Approval Date: Feb 3, 2022
Applicant Holder Full Name: NOVAST LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
PRAMIPEXOLE DIHYDROCHLORIDE (PRAMIPEXOLE DIHYDROCHLORIDE)
2.25MG
Marketing Status: Prescription
Active Ingredient: PRAMIPEXOLE DIHYDROCHLORIDE
Proprietary Name: PRAMIPEXOLE DIHYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 2.25MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A213444
Product Number: 004
Approval Date: Feb 3, 2022
Applicant Holder Full Name: NOVAST LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
PRAMIPEXOLE DIHYDROCHLORIDE (PRAMIPEXOLE DIHYDROCHLORIDE)
3MG
Marketing Status: Prescription
Active Ingredient: PRAMIPEXOLE DIHYDROCHLORIDE
Proprietary Name: PRAMIPEXOLE DIHYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 3MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A213444
Product Number: 005
Approval Date: Feb 3, 2022
Applicant Holder Full Name: NOVAST LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
PRAMIPEXOLE DIHYDROCHLORIDE (PRAMIPEXOLE DIHYDROCHLORIDE)
3.75MG
Marketing Status: Prescription
Active Ingredient: PRAMIPEXOLE DIHYDROCHLORIDE
Proprietary Name: PRAMIPEXOLE DIHYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 3.75MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A213444
Product Number: 006
Approval Date: Feb 3, 2022
Applicant Holder Full Name: NOVAST LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
PRAMIPEXOLE DIHYDROCHLORIDE (PRAMIPEXOLE DIHYDROCHLORIDE)
4.5MG
Marketing Status: Prescription
Active Ingredient: PRAMIPEXOLE DIHYDROCHLORIDE
Proprietary Name: PRAMIPEXOLE DIHYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 4.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A213444
Product Number: 007
Approval Date: Feb 3, 2022
Applicant Holder Full Name: NOVAST LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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