Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 208944

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GOCOVRI (AMANTADINE HYDROCHLORIDE)
EQ 68.5MG BASE Marketing Status: Prescription

Active Ingredient: AMANTADINE HYDROCHLORIDE
Proprietary Name: GOCOVRI
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: EQ 68.5MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N208944
Product Number: 001
Approval Date: Aug 24, 2017
Applicant Holder Full Name: ADAMAS PHARMA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

GOCOVRI (AMANTADINE HYDROCHLORIDE)
EQ 137MG BASE Marketing Status: Prescription

Active Ingredient: AMANTADINE HYDROCHLORIDE
Proprietary Name: GOCOVRI
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: EQ 137MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N208944
Product Number: 002
Approval Date: Aug 24, 2017
Applicant Holder Full Name: ADAMAS PHARMA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

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