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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 215211

Marketing Status: Prescription
Active Ingredient: MIGLUSTAT
Proprietary Name: OPFOLDA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 65MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N215211
Product Number: 001
Approval Date: Sep 28, 2023
Applicant Holder Full Name: AMICUS THERAPEUTICS US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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