Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 212797

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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: A212797
Product Number: 001
Approval Date: Jun 11, 2021
Applicant Holder Full Name: XIAMEN LP PHARMACUETICAL CO 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: A212797
Product Number: 002
Approval Date: Jun 11, 2021
Applicant Holder Full Name: XIAMEN LP PHARMACUETICAL CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information