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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 204595

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FELBAMATE (FELBAMATE)
400MG
Marketing Status: Prescription
Active Ingredient: FELBAMATE
Proprietary Name: FELBAMATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 400MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204595
Product Number: 001
Approval Date: Jan 11, 2016
Applicant Holder Full Name: ALVOGEN INC
Marketing Status:  Prescription
Patent and Exclusivity Information
FELBAMATE (FELBAMATE)
600MG
Marketing Status: Prescription
Active Ingredient: FELBAMATE
Proprietary Name: FELBAMATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 600MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204595
Product Number: 002
Approval Date: Jan 11, 2016
Applicant Holder Full Name: ALVOGEN INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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