Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 206863

10MG Marketing Status: Prescription

Active Ingredient: DALFAMPRIDINE
Proprietary Name: DALFAMPRIDINE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A206863
Product Number: 001
Approval Date: Jul 11, 2018
Applicant Holder Full Name: ACCORD HEALTHCARE INC
Marketing Status:  Prescription
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