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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022250

Marketing Status: Prescription
Active Ingredient: DALFAMPRIDINE
Proprietary Name: AMPYRA
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 10MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N022250
Product Number: 001
Approval Date: Jan 22, 2010
Applicant Holder Full Name: ACORDA THERAPEUTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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