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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 208277

FYCOMPA (PERAMPANEL)
0.5MG/ML
Marketing Status: Prescription
Active Ingredient: PERAMPANEL
Proprietary Name: FYCOMPA
Dosage Form; Route of Administration: SUSPENSION; ORAL
Strength: 0.5MG/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N208277
Product Number: 001
Approval Date: Apr 29, 2016
Applicant Holder Full Name: EISAI INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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