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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 210158

DALFAMPRIDINE (DALFAMPRIDINE)
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: A210158
Product Number: 001
Approval Date: Mar 11, 2019
Applicant Holder Full Name: MICRO LABS LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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