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