Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 212489

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ONGENTYS (OPICAPONE)
25MG
Marketing Status: Prescription
Active Ingredient: OPICAPONE
Proprietary Name: ONGENTYS
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 25MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N212489
Product Number: 001
Approval Date: Apr 24, 2020
Applicant Holder Full Name: NEUROCRINE BIOSCIENCES INC
Marketing Status:  Prescription
Patent and Exclusivity Information
ONGENTYS (OPICAPONE)
50MG
Marketing Status: Prescription
Active Ingredient: OPICAPONE
Proprietary Name: ONGENTYS
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 50MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N212489
Product Number: 002
Approval Date: Apr 24, 2020
Applicant Holder Full Name: NEUROCRINE BIOSCIENCES INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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