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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 208623

GALAFOLD (MIGALASTAT HYDROCHLORIDE)
EQ 123MG BASE
Marketing Status: Prescription
Active Ingredient: MIGALASTAT HYDROCHLORIDE
Proprietary Name: GALAFOLD
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 123MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N208623
Product Number: 001
Approval Date: Aug 10, 2018
Applicant Holder Full Name: AMICUS THERAPEUTICS US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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